STELARA

Package leaflet: Information for the user

STELARA 130 mg concentrate for solution for infusion

ustekinumab
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
This leaflet has been written for people who are taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Stelara is and what it is used for
2. What you need to know before using Stelara
3. How Stelara will be used
4. Possible side effects
5. How to store Stelara
6. Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is
Stelara contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific target proteins in the body.
Stelara belongs to a group of medicines called "immunosuppressants". These medicines partially reduce the activity of the immune system.

What Stelara is used for
Stelara is used to treat the following inflammatory diseases:

• moderate to severe Crohn's disease in adults and children weighing at least 40 kg;
• moderate to severe ulcerative colitis in adults.

Crohn's disease
Crohn's disease is an inflammatory bowel disease. If you have Crohn's disease, you will first be treated with other medicines. If you do not respond adequately or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory bowel disease. If you have ulcerative colitis, you will first be treated with other medicines. If you do not respond adequately or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

2. What you should know before using Stelara

Do not use Stelara

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below)
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using Stelara.
Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check your health status before starting treatment. Make sure to inform your doctor about any medical conditions you have before treatment. Also, inform your doctor if you have recently been in contact with someone who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Stelara. If your doctor believes you are at risk for tuberculosis, you may be given medication to treat it.
Be aware of serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Stelara. See "Serious side effects" in section 4 for a complete list of these side effects.
Before using Stelara, contact your doctor

• If you have ever had an allergic reaction to Stelara. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Stelara partially weaken the immune system, which may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you currently have or recently had an infection or have abnormal openings in the skin (fistulas).
• If you have ever had any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments can also partially reduce immune system activity. The concomitant use of these therapies with Stelara has not been studied. However, it may increase the likelihood of conditions related to immune system weakening.
• If you are using or have ever used injections for allergy treatment – it is not known whether Stelara may affect them.
• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before starting treatment with Stelara.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in areas of skin exposed to sunlight, or if you experience joint pain.
Heart attack and stroke
In a study of patients with psoriasis treated with Stelara, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or unusual sensations on one side of the body, facial drooping, or speech or vision disturbances.
Children and adolescents
Stelara is not recommended for the treatment of children weighing less than 40 kg with Crohn’s disease, nor for children and adolescents under 18 years of age with ulcerative colitis, as it has not been studied in these age groups.
Other medicines, vaccines, and Stelara
Inform your doctor or pharmacist:

• if you are currently taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be administered while you are using Stelara.
• if you received Stelara during pregnancy, inform your child’s pediatrician about the Stelara treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Stelara during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s pediatrician.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
• No increased risk of congenital malformations has been observed in newborns exposed to Stelara in utero. However, experience with Stelara in pregnant women is limited. Therefore, it is preferable to avoid using Stelara during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Stelara and for at least 15 weeks after stopping treatment with Stelara.
• Stelara can cross the placenta and reach the unborn child. If you received Stelara during pregnancy, your child may have an increased risk of developing infections.
• If you received Stelara during pregnancy, it is important to inform your child’s pediatrician and other healthcare providers before your child receives any vaccine. If you received Stelara during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the pediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Stelara. You cannot do both.

Driving and using machines
Stelara has no or negligible effect on the ability to drive vehicles or operate machinery.
Stelara contains sodium
Stelara contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially "sodium-free".
However, before Stelara is administered, it is mixed with a solution containing sodium. Speak with your doctor if you are on a low-salt diet.
Stelara contains polysorbate 80
STELARA contains 10.8 mg of polysorbate 80 (E433) per dose, equivalent to 0.40 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How Stelara will be used

Stelara is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.
Stelara 130 mg concentrate for solution for infusion will be administered by your doctor through an intravenous infusion (a drip into a vein in the arm) for at least one hour. Discuss with your doctor when you should have your infusions and follow-up appointments.

How much Stelara is administered
Your doctor will decide how much Stelara you need and for how long.

Adults from 18 years of age

• Your doctor will calculate the recommended intravenous infusion dose based on your body weight.

Body weight Dose
≤55 kg 260 mg

55 kg to ≤85 kg 390 mg
85 kg 520 mg

• 8 weeks after the initial intravenous dose, you will receive the next dose of 90 mg of Stelara as an injection under the skin (subcutaneous injection), followed by maintenance doses every 12 weeks.

Children with Crohn's disease weighing at least 40 kg

• Your doctor will calculate the recommended intravenous infusion dose based on body weight.

Body weight Dose
≥40 to ≤55 kg 260 mg

55 kg to ≤85 kg 390 mg
85 kg 520 mg

• 8 weeks after the initial intravenous dose, you will receive the next dose of 90 mg of Stelara as an injection under the skin (subcutaneous injection), followed by maintenance doses every 12 weeks.

How Stelara is administered
The first dose of Stelara for the treatment of Crohn's disease or ulcerative colitis is administered by your doctor via an intravenous infusion (a drip into a vein in the arm).
Inform your doctor if you have any questions about the use of Stelara.

If you forget to use Stelara
If you forget or miss your scheduled dose, contact your doctor to arrange a new appointment.

If you stop using Stelara
Stopping treatment with Stelara is not dangerous. However, if you discontinue treatment, your symptoms may return.

If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Some patients may experience serious side effects that may require urgent treatment.
Allergic reactions – these may require urgent treatment, so contact your doctor or seek emergency medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking Stelara (occurring in up to 1 in 1,000 patients). Signs include:

  • Difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or lightheadedness
  • Swelling of the face, lips, mouth or throat.

• Common signs of an allergic reaction include rash and hives (occurring in up to 1 in 100 patients).

Infusion-related reactions – If you are being treated for Crohn’s disease or ulcerative colitis,
your first dose of Stelara is given as an intravenous infusion. Some patients have experienced severe allergic reactions during the infusion.
Allergic lung reactions and lung inflammation have been reported rarely in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, or fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use Stelara again.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections and common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Stelara may reduce your body’s ability to fight infections. Some infections may become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). In patients treated with ustekinumab, opportunistic infections of the brain (encephalitis, meningitis), lungs and eyes have been reported.
You should be alert for signs of infection while using Stelara. These include:

• Fever, flu-like symptoms, night sweats, weight loss
• Feeling tired or short of breath, persistent cough
• Warm, red, painful skin, or a painful blistering rash
• Burning sensation when urinating
• Diarrhea
• Vision problems or loss of vision
• Headache, stiff neck, sensitivity to light, nausea or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be symptoms of infections such as chest infections, skin infections, herpes zoster or opportunistic infections, which may lead to serious complications. Contact your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Stelara until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell’s palsy"), which is usually temporary
• Worsening of psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a rash with small red or purple bumps, fever or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching and pain (bullous pemphigoid)
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on sun-exposed skin areas, sometimes with joint pain)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Stelara

• Stelara 130 mg concentrate for solution for infusion is administered in a hospital or clinic setting, and patients do not need to handle or store it.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Keep the vial in the outer packaging to protect the medicine from light.
• Do not shake Stelara vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after “Exp.”. The expiry date refers to the last day of the month.
• If the liquid has changed colour, is cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of Stelara and contents of the container”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been shaken vigorously.
• If the seal is broken.

Stelara is for single use only. Any unused diluted solution for infusion remaining in the vial and syringe must be discarded according to local regulations.

6. Package contents and other information

What Stelara contains

• The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
• The excipients are: disodium edetate dihydrate (E385), L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Stelara and contents of the pack
Stelara is a clear concentrate for solution for infusion, colourless to pale yellow. It is supplied in a
carton pack containing one single dose in a 30 mL glass vial. Each vial contains 130 mg of
ustekinumab in 26 mL of concentrate for solution for infusion.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands
For further information on this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: + 32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]
България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11
[email protected] [email protected]
Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]
Danmark Malta
Janssen-Cilag A/S AM MANGION LTD.
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]
Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected] [email protected]
Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: + 47 24 12 65 00
[email protected] [email protected]
Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000
España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: + 48 22 237 60 00
[email protected]
France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]
Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]
Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]
Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor hf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]
Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]
Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Tηλ: +357 22 207 700 Tfn +46 8 626 50 00
[email protected]
Latvija United Kingdom (Northern Ireland)
UAB "JOHNSON & JOHNSON" filiāle Janssen Sciences Ireland UC
Latvijā Tel: +44 1 494 567 444
Tel: +371 678 93561 [email protected]
[email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu.

---

The following information is intended exclusively for healthcare professionals.

Traceability
In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product must be clearly recorded.
Instructions for dilution.
STELARA concentrate for solution for infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique.

1. Calculate the dose and the number of STELARA vials required based on the patient's body weight (see section 3, Table 1, Table 2). Each 26 mL vial of STELARA contains 130 mg of ustekinumab.
2. Remove and discard a volume of 9 mg/mL (0.9%) sodium chloride solution from the 250 mL infusion bag equal to the volume of STELARA to be added (discard 26 mL of sodium chloride solution for each required STELARA vial; for 2 vials, discard 52 mL; for 3 vials, discard 78 mL; for 4 vials, discard 104 mL).
3. Withdraw 26 mL of STELARA from each required vial and add it to the 250 mL infusion bag. The final volume in the infusion bag must be 250 mL. Gently mix.
4. Visually inspect the diluted solution before infusion. Do not use if visible opaque particles, discoloration, or foreign particles are observed.
5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion must be completed within eight hours of dilution in the infusion bag.
6. Use a single infusion set with an in-line sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometers).
7. Each vial is for single use only, and any unused medicinal product must be disposed of in accordance with local regulations.

Storage
If necessary, the diluted infusion solution can be stored at room temperature.
The infusion must be completed within 8 hours after dilution in the infusion bag. Do not freeze.

Package leaflet: Information for the user

STELARA 45 mg solution for injection

ustekinumab
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet has been written for people taking this medicine. If you are the parent or caregiver of a child who is to be given Stelara, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Stelara is and what it is used for
2. What you need to know before using Stelara
3. How to use Stelara
4. Possible side effects
5. How to store Stelara
6. Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is
Stelara contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific target proteins in the body.
Stelara belongs to a group of medicines called "immunosuppressants". These medicines partially reduce the activity of the immune system.

What Stelara is used for
Stelara is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn's disease in adults and children weighing at least 40 kg
• moderate to severe ulcerative colitis in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Stelara will reduce inflammation and other signs of the disease.
Stelara is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or in whom these treatments have not worked.
Stelara is used in children and adolescents from 6 years of age with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not been effective.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these treatments, you may be given Stelara to:

• reduce the signs and symptoms of the disease
• improve physical function
• slow down joint damage.

Crohn's disease
Crohn's disease is an inflammatory bowel disease. If you have Crohn's disease, you will first be treated with other medications. If you do not respond adequately or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory bowel disease. If you have ulcerative colitis, you will first be treated with other medicines. If you do not respond adequately or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

2. What you should know before using Stelara

Do not use Stelara

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or
pharmacist before using Stelara.
Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check your health status
before each treatment. Make sure to inform your doctor, before each treatment, about any medical
conditions you have. In addition, inform your doctor if you have recently been in contact with people
who may have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis
before administering Stelara. If your doctor believes you are at risk of tuberculosis, you may be given
medicines to treat tuberculosis.

Be aware of serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You should pay
attention to certain signs of illness while taking Stelara. See “Serious side effects” in section 4 for a
complete list of these side effects.

Contact your doctor before using Stelara:

• If you have ever had an allergic reaction to Stelara. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants such as Stelara partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you currently have or have recently had an infection.
• If you have ever had any new or changed lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The concomitant use of these therapies with Stelara has not been

studied. However, it may increase the likelihood of conditions related to a weakened immune system.

• If you are using or have ever used injections for allergy treatment – it is not known whether Stelara may affect them.
• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or
pharmacist before starting treatment with Stelara.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including
cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if
you develop a red, raised, scaly rash, sometimes with a darker border, in sun-exposed areas of skin or if
you experience joint pain.

Heart attack and stroke
In a study of psoriasis patients treated with Stelara, heart attacks and strokes were observed. Your
doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately
managed. Seek immediate medical attention if you develop chest pain, weakness or a strange sensation
on one side of the body, facial drooping, or speech or vision problems.

Children and adolescents
Stelara is not recommended for the treatment of children under 6 years of age with psoriasis, children
with Crohn’s disease weighing less than 40 kg, or children under 18 years of age with psoriatic arthritis
or ulcerative colitis, as it has not been studied in these age groups.

Other medicines, vaccines, and Stelara
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Stelara.
• if you received Stelara during pregnancy, inform your child's paediatrician about the Stelara treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Stelara during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child's paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you might be pregnant, or are planning a pregnancy, ask your doctor for advice before taking this medicine.
• In newborns exposed to Stelara in the womb, no increased risk of congenital malformations has been observed. However, experience with Stelara in pregnant women is limited. Therefore, it is preferable to avoid using Stelara during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Stelara and for at least 15 weeks after stopping treatment with Stelara.
• Stelara can cross the placenta and reach the unborn child. If you received Stelara during pregnancy, your child may have an increased risk of developing infections.
• If you received Stelara during pregnancy, it is important to inform your child's paediatrician and other healthcare providers before your child receives any vaccine. If you received Stelara during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child's paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Stelara. You cannot do both.

Driving and using machines
Stelara has no effect or has a negligible effect on the ability to drive or use machines.

Stelara contains polysorbate 80
STELARA contains 0.02 mg of polysorbate 80 (E433) per dose, equivalent to 0.04 mg/mL. Polysorbates
may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Stelara

Stelara is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Stelara is indicated.
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor. Discuss with your doctor when you should receive your injections and follow-up appointments.

How much Stelara is administered

Your doctor will decide how much Stelara you need and for how long.

Adults from 18 years of age

Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Stelara. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by subsequent doses every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease or ulcerative colitis

• During treatment, the first dose of approximately 6 mg/kg of Stelara is administered by your doctor via an intravenous infusion (IV infusion) into the arm.
• Eight weeks after the initial dose, you will receive the next dose of 90 mg of Stelara, followed by subsequent doses every 12 weeks via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Stelara may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age

Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Stelara to be injected, to ensure the correct dose is administered. The correct dose depends on the child’s body weight at the time of each administration.
• If body weight is less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Stelara.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Stelara.
• Four weeks after the initial dose, the next dose should be administered, followed by subsequent doses every 12 weeks.

Children weighing at least 40 kg

Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Stelara is administered by your doctor via an intravenous infusion (IV infusion) into the arm.
• Eight weeks after the initial dose, you will receive the next dose of 90 mg of Stelara, followed by subsequent doses every 12 weeks via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Stelara may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Stelara is administered

Stelara is administered via subcutaneous injection (“subcutaneously”). At the beginning of treatment, medical or nursing staff may administer Stelara to you.

• However, you and your doctor may decide whether you can self-inject Stelara. In this case, you will be trained on how to self-inject Stelara.
• For instructions on how to inject Stelara, see “Instructions for Administration” at the end of this leaflet. Inform your doctor if you have any questions about self-injection.

If you use more Stelara than you should

If you have used or received too much Stelara, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.

If you forget to use Stelara

If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.

If you stop using Stelara

Stopping treatment with Stelara is not dangerous. However, if you stop treatment, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Some patients may experience serious side effects that may require urgent treatment.
Allergic reactions – these may require urgent treatment, so contact your doctor or seek
immediate medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking Stelara (affecting up to 1 in 1,000 patients). Signs include: difficulty breathing or swallowing, low blood pressure (which may cause dizziness or a feeling of lightheadedness), or swelling of the face, lips, mouth, or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients
receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as
cough, shortness of breath, or fever.
If you experience a severe allergic reaction, your doctor may decide that you should no longer use Stelara.
Infections – these may require urgent treatment, so contact your doctor immediately if you
notice any of the following signs.

• Nasal, throat infections, and common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Stelara may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis), or parasites, including infections that primarily occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.
You should be aware of signs of infection while taking Stelara. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• visual disturbances or loss of vision
• headache, neck stiffness, sensitivity to light, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be symptoms of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which can have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Stelara until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may
be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin
conditions. If you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching, and pain (bullous pemphigoid)
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on sun-exposed areas of skin, sometimes accompanied by joint pain)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Stelara

• Keep this medicine out of the sight and reach of children.
• Store in the refrigerator (2°C - 8°C). Do not freeze.
• Keep the vial in the outer packaging to protect the medicine from light.
• Do not shake Stelara vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton following “Exp.”. The expiry date refers to the last day of the month.
• If the liquid has changed colour, is cloudy, or if you see floating foreign particles (see section 6 “Description of the appearance of Stelara and contents of the pack”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been vigorously shaken.
• If the seal is broken.

Stelara is for single use only. Any unused product remaining in the vial and syringe must be
discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Stelara contains

• The active substance is ustekinumab. Each vial contains 45 mg of ustekinumab in 0.5 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Stelara and contents of the pack
Stelara is a solution for injection, from clear to slightly opalescent (pearl-like appearance), colourless to pale yellow. The solution may contain a few small translucent or white protein particles. It is supplied in a cardboard pack containing 1 single dose in a 2 mL glass vial. Each vial contains one dose of ustekinumab 45 mg in 0.5 mL of solution for injection.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: +32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]
България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Tel: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11
[email protected] [email protected]
Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]
Danmark Malta
Janssen-Cilag A/S AM MANGION LTD.
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]
Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected] [email protected]
Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]
Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tel: +30 210 80 90 000
España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]
France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]
Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]
Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]
Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor hf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]
Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]
Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Tel: +357 22 207 700 Tfn +46 8 626 50 00
[email protected]
Latvija United Kingdom (Northern Ireland)
UAB "JOHNSON & JOHNSON" filiāle Janssen Sciences Ireland UC
Latvijā Tel: +44 1 494 567 444
Tel: +371 678 93561 [email protected]
[email protected]
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.
Instructions for administration
At the beginning of treatment, your doctor will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Stelara. In this case, you will be taught how to self-administer Stelara. Inform your doctor if you have any questions about self-injection.

• Do not mix Stelara with other injectable liquids.
• Do not shake Stelara vials, as vigorous shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously.

1. Check the number of vials and prepare materials

Take out the vial(s) from the refrigerator. Leave the vial(s) outside the refrigerator for about 30 minutes. This will allow the liquid to reach a comfortable temperature for injection (room temperature).
Check the following:

• the number of vials and the dose are correct; if your dose is 45 mg or less, you will use one 45 mg Stelara vial; if your dose is 90 mg, you will use two 45 mg Stelara vials and will need to perform two injections. Choose two different body sites for these injections (for example, one injection in the right thigh and the other injection in the left thigh), and perform the injections one after the other. Use a new needle and a new syringe for each injection
• the medicine is the correct one
• the medicine has not expired
• the vial is not damaged and the cap is intact
• the solution in the vial is clear or slightly opalescent (pearl-like appearance) and colorless or pale yellow
• the liquid does not have a changed or cloudy color and does not contain foreign particles
• it has not been frozen.

Children with pediatric psoriasis and a body weight below 60 kg require a dose lower than 45 mg. Be certain of the appropriate amount (volume) to withdraw from the vial and the type of syringe needed for dosing. If you do not know the amount of medicine or the type of syringe to use, contact your doctor for further instructions.
Gather all necessary supplies and place them on a clean surface. You should have a syringe, needle, antiseptic wipes, a cotton ball or gauze, and a sharps container (see Figure 1).

Figure 1

2. Choose and prepare the injection site

Choose an injection site (see Figure 2).

• Stelara is administered by subcutaneous injection (under the skin).
• A suitable injection site is the upper thigh or the area around the abdomen (abdominal area), at least 5 cm away from the navel.
• If possible, avoid areas of skin affected by psoriasis.
• If someone is assisting you during the injection, the upper arm may also be used as an injection site.

Figure 2
Preparing the injection site

• Wash your hands thoroughly with soap and warm water.
• Clean the injection site on the skin with an antiseptic swab.
• Do not touch this area again before giving the injection.

3. Prepare the dose:

• Remove the cap from the top of the vial (see Figure 3).

Figure 3

• Do not remove the stopper.
• Clean the stopper with an antiseptic swab.
• Place the vial on a flat surface.
• Take the syringe and remove the needle protective cap.
• Do not touch the needle, and do not let the needle touch anything.
• Push the needle through the rubber stopper.
• Turn the vial and syringe upside down.
• Pull the plunger of the syringe to draw up the prescribed amount of liquid.
• It is important that the needle tip remains always submerged in the liquid to prevent air bubbles from entering the syringe (see Figure 4).

Figure 4

• Remove the needle from the vial.
• Hold the syringe with the needle pointing upwards to check whether any air bubbles are present.
• If there are air bubbles, gently tap the side of the syringe until the air bubbles rise to the top of the syringe (see Figure 5).

Figure 5

• Then push the plunger slowly until all air has been expelled (but do not expel the liquid).
• Do not place the syringe down and avoid letting the needle touch anything.

4. Inject the dose

• Gently pinch a clean area of skin between your thumb and index finger. Do not squeeze too forcefully.
• Insert the needle into the pinched skin.
• Push the plunger with your thumb until all the liquid has been injected. Press slowly and steadily, keeping the skin gently pinched.
• When the plunger reaches the end of the syringe, remove the needle and release the skin.

5. After the injection

• Press an antiseptic swab on the injection site for a few seconds after the injection.
• There may be a small amount of blood or fluid at the injection site. This is normal.
• You may press a cotton ball or gauze pad on the injection site and hold it for 10 seconds.
• Do not rub the skin at the injection site: you may cover the injection site with a small plaster, if necessary.

6. Disposal

• Used syringes and needles must be placed in a puncture-resistant container, such as a sharps container. For your safety and the safety of others, never reuse needles or syringes. Dispose of the sharps container according to local regulations.
• Empty vials, antiseptic swabs, and other devices may be discarded in regular waste.

Package leaflet: information for the user

STELARA 45 mg solution for injection in pre-filled syringe

ustekinumab
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet is intended for people who are taking this medicine. If you are a parent or caregiver of a child who is to be given Stelara, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Stelara is and what it is used for
2. What you need to know before using Stelara
3. How to use Stelara
4. Possible side effects
5. How to store Stelara
6. Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is
Stelara contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognise and bind to specific target proteins in the body.
Stelara belongs to a group of medicines called "immunosuppressants". These medicines reduce the activity of the immune system to some extent.

What Stelara is used for
Stelara is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults and children weighing at least 40 kg
• moderate to severe ulcerative colitis in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Stelara will reduce inflammation and other signs of the disease.
Stelara is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or in whom these treatments have not worked.
Stelara is used in children and adolescents from 6 years of age with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not been effective.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Stelara to:

• reduce the signs and symptoms of the disease.
• improve physical function.
• slow down joint damage.

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medications. If you do not respond sufficiently or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory bowel disease. If you have ulcerative colitis, you will first be treated with other medicines. If you do not respond sufficiently or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

2. What you should know before using Stelara

Do not use Stelara

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the above conditions apply to you, talk to your doctor or pharmacist before using Stelara.
Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check your health status before each treatment. Make sure to inform your doctor, before each treatment, about any medical conditions you have. Also, inform your doctor if you have recently been in contact with people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Stelara. If your doctor believes you are at risk of tuberculosis, you may be given medications to treat it.
Be aware of serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Stelara. See "Serious side effects" in section 4 for a complete list of these side effects.
Before using Stelara, contact your doctor

• If you have ever had an allergic reaction to Stelara. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Stelara partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changing skin lesions within the area of psoriasis or on normal skin.
• If you have ever had an allergic reaction to latex or to the Stelara injection – the container of this medicinal product contains latex, which may cause severe allergic reactions in people sensitive to latex. See "Be aware of serious side effects" in section 4 for signs of an allergic reaction.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The concomitant use of these therapies with Stelara has not been studied. However, it could increase the likelihood of conditions related to a weakened immune system.
• If you are using or have ever used injections for allergy treatment – it is not known whether Stelara may affect them.
• If you are aged 65 years or older – you may have a higher chance of getting infections.

If you are unsure whether any of the above conditions apply to you, talk to your doctor or pharmacist before starting treatment with Stelara.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on areas of skin exposed to sunlight, or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with Stelara, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or unusual sensations on one side of the body, facial drooping, or speech or vision abnormalities.
Children and adolescents
Stelara is not recommended for the treatment of children with psoriasis under 6 years of age, children with Crohn's disease weighing less than 40 kg, or children under 18 years of age with psoriatic arthritis or ulcerative colitis, as it has not been studied in these age groups.
Other medicines, vaccines and Stelara
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) must not be given while you are using Stelara.
• if you received Stelara during pregnancy, inform your child’s pediatrician about the Stelara treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Stelara during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless the child’s pediatrician recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.

• No increased risk of congenital malformations has been observed in infants exposed to Stelara in utero. However, experience with Stelara in pregnant women is limited. Therefore, it is preferable to avoid using Stelara during pregnancy.

• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Stelara and for at least 15 weeks after stopping treatment.

• Stelara can pass to the unborn child through the placenta. If you received Stelara during pregnancy, your baby may have an increased risk of developing infections.

• If you received Stelara during pregnancy, it is important to inform your child’s pediatrician and other healthcare providers before your child receives any vaccine. If you received Stelara during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless the child’s pediatrician recommends otherwise.

• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Stelara. You cannot do both.

Driving and using machines
Stelara has no effect or a negligible effect on the ability to drive vehicles or operate machinery.
Stelara contains polysorbate 80
STELARA contains 0.02 mg of polysorbate 80 (E433) per dose, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Stelara

Stelara is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Stelara is indicated.
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor. Discuss with your doctor when you should receive your injections and follow-up appointments.

How much Stelara is administered

Your doctor will decide how much Stelara you need and for how long.

Adults from 18 years of age

Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Stelara. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by subsequent doses every 12 weeks. The following doses are usually the same as the initial dose.

Crohn’s disease or ulcerative colitis

• During treatment, the first dose of approximately 6 mg/kg of Stelara is administered by your doctor via an intravenous infusion (IV infusion) into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Stelara, followed by subcutaneous injections (under the skin) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Stelara may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age

Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Stelara to be injected to ensure the correct dose is administered. The correct dose depends on the child's body weight at the time each dose is given.
• A 45 mg vial is available if a dose lower than 45 mg is required.
• If body weight is less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Stelara.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Stelara.
• Four weeks after the initial dose, you will receive the next dose, followed by subsequent doses every 12 weeks.

Children weighing at least 40 kg

Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Stelara is administered by your doctor via an intravenous infusion (IV infusion) into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Stelara, followed by subcutaneous injections (under the skin) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Stelara may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Stelara is administered

Stelara is administered by subcutaneous injection ("subcutaneously").
At the beginning of treatment, medical or nursing staff may administer Stelara to you.

• However, you and your doctor may decide whether you can self-inject Stelara. In this case, you will be trained on how to self-inject Stelara.
• For instructions on how to inject Stelara, see “Instructions for administration” at the end of this leaflet. Inform your doctor if you have any questions about self-injection.

If you use more Stelara than you should

If you have used or received too much Stelara, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.

If you forget to use Stelara

If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.

If you stop using Stelara

It is not dangerous to stop using Stelara. However, if you discontinue treatment, your symptoms may return.

If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Some patients may experience serious side effects that may require treatment.

Allergic reactions – these may require urgent treatment, so contact your doctor or seek emergency medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking Stelara (affecting up to 1 in 1,000 patients). Signs include: difficulty breathing or swallowing, low blood pressure which may cause dizziness or lightheadedness, or swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath and fever.

If you experience a severe allergic reaction, your doctor may decide that you should no longer use Stelara.

Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Stelara may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs and eyes have been reported in patients treated with ustekinumab.

You should be alert for signs of infection while taking Stelara. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warm, red and painful skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• visual disturbances or loss of vision
• headache, neck stiffness, sensitivity to light, nausea or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster or opportunistic infections, which may have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Stelara until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.

Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, you must inform your doctor immediately.

Other side effects

Common side effects (may affect up to 1 in 10 people)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (may affect up to 1 in 100 people)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (may affect up to 1 in 1,000 people)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever or joint pain (vasculitis)

Very rare side effects (may affect up to 1 in 10,000 people)

• Blistering skin rash with possible redness, itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on sun-exposed areas of skin, sometimes with joint pain).

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.

Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Stelara

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Stelara may also be stored at room temperature up to 30°C for a single period of up to 30 days, remaining in the outer packaging to protect from light. Record the date when the pre-filled syringe is first removed from the refrigerator and the date when it should be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a syringe has been stored at room temperature (up to 30°C), it must not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the pre-filled syringes of Stelara. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after EXP or Exp. The expiry date refers to the last day of the month.
• If the liquid has changed colour, appears cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Stelara and contents of the container”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been shaken vigorously. Stelara is for single use only. Any unused product remaining in the syringe must be discarded.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Stelara contains

• The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
• The other ingredients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

What Stelara looks like and contents of the pack
Stelara is a solution for injection that ranges from clear to slightly opalescent (pearl-like appearance), colourless to pale yellow. The solution may contain a few small translucent or white protein particles. It is supplied in a cardboard pack containing 1 single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe contains a dose of ustekinumab 45 mg in 0.5 mL of solution for injection.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: +32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD.
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor hf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Tηλ: +357 22 207 700 Tfn +46 8 626 50 00
[email protected]

Latvija United Kingdom (Northern Ireland)
UAB "JOHNSON & JOHNSON" filiāle Janssen Sciences Ireland UC
Latvijā Tel: +44 1 494 567 444
Tel: +371 678 93561 [email protected]
[email protected]

More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Instructions for administration
At the beginning of treatment, your doctor will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Stelara. If so, you will be taught how to self-inject Stelara. Inform your doctor if you have any questions about self-injection.

• Do not mix Stelara with other injectable liquids.
• Do not shake the pre-filled syringes of Stelara, as vigorous shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously.

Figure 1 shows the appearance of the pre-filled syringe.

Figure 1

1. Check the number of prefilled syringes and prepare the materials

Prepare for the use of the prefilled syringes.

• Remove the prefilled syringe or syringes from the refrigerator. Leave the prefilled syringe outside the carton for about half an hour. This will allow the liquid to reach a comfortable temperature for injection (room temperature). Do not remove the needle protective cap while waiting for the syringe to reach room temperature.
• Hold the prefilled syringe by its barrel with the needle covered and pointing upwards.
• Do not hold the syringe by the plunger head, plunger rod, needle safety clip, or needle protective cap.
• Under no circumstances should you pull back the plunger.
• Do not remove the needle cap from the prefilled syringe until ready to use.
• Do not touch the activation clip for needle safety (as indicated by the asterisk * in Figure 1) to prevent premature covering of the needle by the needle safety clip.

Inspect the prefilled syringe to ensure that:

• the number of prefilled syringes and the dose are correct; if your dose is 45 mg, you will use one 45 mg Stelara prefilled syringe; if your dose is 90 mg, you will use two 45 mg Stelara prefilled syringes and must perform two separate injections. Choose two different injection sites for these injections (e.g., one injection in the right thigh and the other in the left thigh), and administer the injections one after the other
• the medicine is the correct one
• the medicine has not expired
• the prefilled syringe is not damaged
• the solution in the prefilled syringe is clear or slightly opalescent (pearl-like appearance) and colorless to pale yellow
• the liquid in the prefilled syringe is not discolored or cloudy and does not contain foreign particles
• the solution in the prefilled syringe has not been frozen

Gather all necessary supplies and place them on a clean surface. You will need antiseptic swabs, a cotton ball or gauze, and a sharps container.

2. Choose and prepare the injection site

Choose an injection site (see Figure 2).

• Stelara is administered by subcutaneous injection (under the skin).
• Suitable injection sites are the upper thigh or the abdominal area (abdomen), at least 5 cm away from the navel.
• If possible, avoid areas of skin affected by psoriasis.
• If someone is assisting you with the injection, the upper arm may also be used as an injection site.

Figure 2
Preparing the injection site

• Wash your hands thoroughly with soap and warm water.
• Clean the injection site on the skin using an antiseptic swab.
• Do not touch this area again before giving the injection.

3. Remove the needle protective cap (see Figure 3)

• The needle protective cap must not be removed until you are ready to inject the dose.
• Take the pre-filled syringe and hold it by the barrel with one hand.
• Remove and discard the needle protective cap. Do not touch the plunger during this step.

Figure 3

• If you notice an air bubble in the pre-filled syringe or a drop of liquid at the needle tip, this is normal. Do not remove them.
• Do not touch the needle and avoid letting the needle touch any surface.
• Do not use the pre-filled syringe if it is removed from its packaging without the needle protective cap in place. If this happens, consult your doctor or pharmacist.
• Inject the contents immediately after removing the needle protective cap.

4. Inject the dose

• Hold the pre-filled syringe in one hand between the middle finger and index finger, with the thumb placed on top of the plunger head. Use the other hand to gently pinch the cleaned area of skin between the thumb and index finger. Do not pinch too tightly.
• Do not pull back the plunger in any way.
• With one quick motion, insert the needle into the skin as far as possible (see Figure 4).

Figure 4

• Inject all the liquid by pushing the plunger until the plunger head is completely within the needle guard wings (see Figure 5).

Figure 5

• Push the plunger until it reaches the end of its travel, and continue to keep pressure on the plunger head while withdrawing the needle and gently releasing the skin (see Figure 6).

Figure 6

• Slowly remove your thumb from the plunger head, allowing the empty syringe to move upward so that the needle is completely covered by the needle guard wings, as shown in Figure 7.

Figure 7

5. After the injection

• Press a sterile swab on the injection site for a few seconds after the injection.
• There may be a small amount of blood or fluid at the injection site. This is normal.
• You may press a cotton ball or gauze pad on the injection site and hold it for 10 seconds.
• Do not rub the skin at the injection site: you may cover the injection site with a small plaster, if needed.

6. Disposal

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 8). For your health and safety and for the safety of others, never reuse the syringe. Dispose of the sharps container according to local regulations.
• Antiseptic swabs and other devices may be disposed of in regular waste.

Figure 8

Package leaflet: information for the user

STELARA 90 mg solution for injection in pre-filled syringe

ustekinumab
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet is intended for people who are taking this medicine. If you are a parent or caregiver administering Stelara to a child, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Stelara is and what it is used for
2. What you need to know before using Stelara
3. How to use Stelara
4. Possible side effects
5. How to store Stelara
6. Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is
Stelara contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific target proteins in the body.
Stelara belongs to a group of medicines called "immunosuppressants". These medicines partially reduce the activity of the immune system.

What Stelara is used for
Stelara is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults and children weighing at least 40 kg
• moderate to severe ulcerative colitis in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Stelara will reduce inflammation and other signs of the disease.
Stelara is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or in whom these treatments have not worked.
Stelara is used in children and adolescents from 6 years of age with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not been effective.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Stelara to:

• reduce the signs and symptoms of the disease
• improve physical function
• slow down joint damage

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medications. If you do not respond sufficiently or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory bowel disease. If you have ulcerative colitis, you will first be treated with other medicines. If you do not respond sufficiently or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

2. What you should know before using Stelara

Do not use Stelara

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or
pharmacist before using Stelara.
Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check your health status
before each treatment. Make sure to inform your doctor about any medical conditions you have before
each treatment. Also, tell your doctor if you have recently been in contact with people who might have
had tuberculosis. Your doctor will examine you and carry out tests for tuberculosis before administering
Stelara. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat it.
Be aware of serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You should be aware
of certain signs of illness while taking Stelara. See “Serious side effects” in section 4 for a complete list
of these side effects.
Contact your doctor before using Stelara

• If you have ever had an allergic reaction to Stelara. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Stelara partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you have ever had an allergic reaction to latex or to the Stelara injection – the container of this medicinal product contains latex, which may cause severe allergic reactions in people sensitive to latex. See “Be aware of serious side effects” in section 4 for signs of an allergic reaction.
• If you are receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The use of these therapies together with Stelara has not been studied. However, it could increase the risk of conditions related to a weakened immune system.
• If you are using or have ever used allergy shots (injections for the treatment of allergies) – it is not known whether Stelara may affect them.
• If you are aged 65 years or older – you may have a higher chance of getting infections.

If you are unsure whether any of the above conditions apply to you, talk to your doctor or
pharmacist before starting treatment with Stelara.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including
cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you
develop a red, raised, scaly rash, sometimes with a darker border, on sun-exposed areas of skin, or if you
have joint pain.
Heart attack and stroke
In a study of patients with psoriasis treated with Stelara, heart attacks and strokes were observed. Your
doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately
managed. Seek immediate medical attention if you develop chest pain, weakness or a strange sensation
on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Stelara is not recommended for the treatment of children under 6 years of age with psoriasis, children
with Crohn’s disease weighing less than 40 kg, or children under 18 years of age with psoriatic arthritis
or ulcerative colitis, as it has not been studied in these age groups.
Other medicines, vaccines and Stelara
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Stelara.
• if you received Stelara during pregnancy, inform your child’s paediatrician about the Stelara treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Stelara during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.

• In newborns exposed to Stelara in the womb, no increased risk of congenital malformations has been observed. However, experience with Stelara in pregnant women is limited. Therefore, it is preferable to avoid using Stelara during pregnancy.

• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Stelara and for at least 15 weeks after stopping treatment with Stelara.

• Stelara can pass to the unborn child through the placenta. If you received Stelara during pregnancy, your child may have an increased risk of developing an infection.

• If you received Stelara during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Stelara during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, ask your doctor for advice. You and your doctor will decide whether you should breastfeed or use Stelara. You cannot do both.

Driving and using machines
Stelara has no or negligible effect on the ability to drive or use machines.
Stelara contains polysorbate 80
STELARA contains 0.04 mg of polysorbate 80 (E433) per dose, equivalent to 0.04 mg/mL. Polysorbates
may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Stelara

Stelara is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Stelara is indicated.
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor. Discuss with your doctor when you should receive your injections and follow-up visits.

How much Stelara is administered

Your doctor will decide how much Stelara you need and for how long.

Adults from 18 years of age

Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Stelara. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease or ulcerative colitis

• During treatment, the first dose of approximately 6 mg/kg of Stelara is administered by your doctor as an intravenous infusion into a vein in the arm (intravenous infusion). Eight weeks after the initial dose, you will receive the next dose of 90 mg of Stelara, followed by subcutaneous injections (subcutaneous route) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Stelara may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age

Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Stelara to be injected to ensure the correct dose is administered. The correct dose will depend on the child’s body weight at the time each dose is given.
• A 45 mg vial is available if a dose lower than 45 mg is required.
• If body weight is less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Stelara.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Stelara.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks.

Children weighing at least 40 kg

Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Stelara is administered by your doctor as an intravenous infusion into a vein in the arm (intravenous infusion). Eight weeks after the initial dose, you will receive the next dose of 90 mg of Stelara, followed by subcutaneous injections (subcutaneous route) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Stelara may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Stelara is administered

Stelara is administered by subcutaneous injection (“subcutaneous route”).
At the beginning of treatment, medical or nursing staff may administer Stelara to you.

• However, you and your doctor may decide whether you can self-inject Stelara. In this case, you will be trained on how to self-inject Stelara.
• For instructions on how to inject Stelara, see “Instructions for administration” at the end of this patient information leaflet. Inform your doctor if you have any questions about self-injection.

If you use more Stelara than you should

If you have used or received too much Stelara, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.

If you forget to use Stelara

If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.

If you stop using Stelara

Stopping treatment with Stelara is not dangerous. However, if you discontinue treatment, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Some patients may experience serious side effects that may require treatment.
Allergic reactions – these may require urgent treatment, so contact your doctor or seek urgent medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking Stelara (affecting up to 1 in 1,000 patients). Signs include:
  o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of lightheadedness, or
  o swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include rash and hives (urticaria) (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, or fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use Stelara again.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue under the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Stelara may reduce your ability to fight infections. Some infections may become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs and eyes have been reported in patients treated with ustekinumab.
You should be alert for signs of infection while using Stelara. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• visual disturbance or loss of vision
• headache, neck stiffness, sensitivity to light, nausea or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster or opportunistic infections, which may have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Stelara until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, you must inform your doctor immediately.
Other side effects
Common side effects (affecting up to 1 in 10 people)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affecting up to 1 in 100 people)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affecting up to 1 in 1,000 people)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever or joint pain (vasculitis)

Very rare side effects (affecting up to 1 in 10,000 people)

• Blistering skin rash with possible redness, itching and pain (bullous pemphigoid)
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash on areas of skin exposed to sunlight, sometimes with joint pain)

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Stelara

• Keep this medicine out of the sight and reach of children.
• Store in the refrigerator (2°C – 8°C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Stelara may also be stored at room temperature up to 30°C for a single period of maximum 30 days, remaining in the outer packaging to protect them from light. Record the date when the pre-filled syringe is first removed from the refrigerator and the date by which it must be discarded in the space provided on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a syringe has been stored at room temperature (up to 30°C), it must not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the pre-filled syringes of Stelara. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after EXP or Exp. The expiry date refers to the last day of the month.
• If the solution has changed colour, is cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of Stelara and contents of the pack”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been shaken vigorously. Stelara is for single use only. Any unused product remaining in the syringe must be discarded.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Stelara contains

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Stelara and contents of the pack
Stelara is a solution for injection ranging from clear to slightly opalescent (pearl-like appearance), colourless to pale yellow. The solution may contain a few small translucent or white protein particles. It is supplied in a cardboard pack containing one single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe contains one dose of ustekinumab 90 mg in 1 mL of solution for injection.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: + 32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD.
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: + 47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: + 48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 21 43 68 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor hf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Tηλ: +357 22 207 700 Tfn +46 8 626 50 00
[email protected]

Latvija United Kingdom (Northern Ireland)
UAB "JOHNSON & JOHNSON" filiāle Janssen Sciences Ireland UC
Latvijā Tel: +44 1 494 567 444
Tel: +371 678 93561 [email protected]
[email protected]

More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

Instructions for administration

At the beginning of treatment, your doctor will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Stelara. In this case, you will be taught how to self-administer Stelara. Inform your doctor if you have any questions about self-injection.

• Do not mix Stelara with other injectable liquids.
• Do not shake the pre-filled syringes of Stelara, as vigorous shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously.

Figure 1 shows the appearance of the pre-filled syringe.

Figure 1

1. Check the number of prefilled syringes and prepare materials

Prepare for the use of prefilled syringes.

• Remove the prefilled syringe or prefilled syringes from the refrigerator. Leave the prefilled syringe outside the carton for about half an hour. This will allow the liquid to reach a comfortable injection temperature (room temperature). Do not remove the needle protective cap while waiting for the syringe to reach room temperature.
• Hold the prefilled syringe by its barrel with the covered needle pointing upwards.
• Do not hold it by the plunger rod, plunger, needle safety clip, or needle protective cap.
• Under no circumstances should the plunger be pulled back.
• Do not remove the needle cap from the prefilled syringe until ready to use.
• Do not touch the safety clip activation clip (as indicated by the asterisk * in Figure 1) to prevent premature needle coverage by the needle safety clip.

Inspect the prefilled syringe to ensure that:

• the number of prefilled syringes and the dose are correct; or if your dose is 90 mg, you will use one 90 mg Stelara prefilled syringe
• the medicine is the correct one
• the medicine has not expired
• the prefilled syringe is not damaged
• the solution in the prefilled syringe is clear or slightly opalescent (pearl-like appearance) and colorless to pale yellow
• the liquid in the prefilled syringe does not have a changed or cloudy color and does not contain foreign particles
• the solution in the prefilled syringe has not been frozen.

Gather all necessary supplies and place them on a clean surface. You will need antiseptic wipes, a cotton ball or gauze, and a sharps container.

2. Choose and prepare the injection site

Choose a site for the injection (see Figure 2).

• Stelara is administered by subcutaneous injection (under the skin).
• A suitable injection site is the upper thigh or the abdominal area (abdomen), at least 5 cm away from the navel.
• If possible, avoid areas of skin affected by psoriasis.
• If someone is assisting you during the injection, the upper arm may also be used as an injection site.

Figure 2
Preparing the injection site.

• Wash your hands thoroughly with soap and warm water.
• Clean the injection site on the skin with an antiseptic swab.
• Do not touch this area again before giving the injection.

3. Remove the needle protective cap (see Figure 3)

• The needle protective cap must not be removed until you are ready to inject the dose.
• Take the pre-filled syringe and hold it by the barrel with one hand.
• Remove and discard the needle protective cap. Do not touch the plunger during this step.

Figure 3

• If you notice an air bubble in the pre-filled syringe or a drop of liquid at the tip of the needle, this is normal. Do not remove them.
• Do not touch the needle and avoid contact between the needle and any surface.
• Do not use the pre-filled syringe if it is removed without the needle protective cap in place. If this happens, consult your doctor or pharmacist.
• Inject the contents immediately after removing the needle protective cap.

4. Inject the dose

• Hold the pre-filled syringe with one hand between the middle finger and index finger, placing the thumb on top of the plunger. Use the other hand to gently pinch the cleaned area of skin between the thumb and index finger. Do not squeeze too tightly.
• Do not pull back the plunger in any way.
• With one quick motion, insert the needle into the skin as far as possible (see Figure 4).

Figure 4

• Inject all the liquid by pushing the plunger until the plunger head is completely within the needle guard wings (see Figure 5).

Figure 5

• Push the plunger until it reaches the end of its travel, and continue to keep pressure on the plunger head while withdrawing the needle and gently releasing the skin (see Figure 6).

Figure 6

• Slowly remove your thumb from the plunger head, allowing the empty syringe to move upward so that the needle is completely covered by the needle guard wings, as shown in Figure 7.

Figure 7

5. After the injection

• Press an antiseptic swab on the injection site for a few seconds after the injection.
• There may be a small amount of blood or fluid at the injection site. This is normal.
• You may press a cotton ball or gauze pad on the injection site and hold it for 10 seconds.
• Do not rub the skin at the injection site: you may cover the injection site with a small plaster, if necessary.

6. Disposal

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 8). For your safety and the safety of others, never reuse the syringe. Dispose of the sharps container according to local regulations.
• Antiseptic swabs and other devices may be discarded in regular waste.

Figure 8

Package leaflet: Information for the user

STELARA 45 mg solution for injection in a prefilled pen

ustekinumab
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet has been written for people who are taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Stelara is and what it is used for
2. What you need to know before using Stelara
3. How to use Stelara
4. Possible side effects
5. How to store Stelara
6. Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is
Stelara contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific target proteins in the body.
Stelara belongs to a group of medicines called "immunosuppressants". These medicines partially reduce the activity of the immune system.

What Stelara is used for
Stelara administered via a pre-filled pen is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults)
• psoriatic arthritis (in adults)
• moderate to severe Crohn's disease in adults
• moderate to severe ulcerative colitis in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Stelara will reduce inflammation and other signs of the disease.
Stelara administered via a pre-filled pen is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate or phototherapy, or in whom these treatments are ineffective.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Stelara to:

• reduce the signs and symptoms of the disease.
• improve physical function.
• slow down joint damage.

Crohn's disease
Crohn's disease is an inflammatory bowel disease. If you have Crohn's disease, you will first be treated with other medications. If you do not respond adequately or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory bowel disease. If you have ulcerative colitis, you will first be treated with other medicines. If you do not respond adequately or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Stelara

Do not use Stelara

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or
pharmacist before using Stelara.
Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check your health status
before each treatment. Make sure to inform your doctor, before each treatment, about any medical
conditions you have. In addition, inform your doctor if you have recently been in contact with people
who may have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis
before administering Stelara. If your doctor believes you are at risk of tuberculosis, you may be given
medicines to treat tuberculosis.
Be aware of serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You should pay
attention to certain signs of illness while taking Stelara. See “Serious side effects” in section 4 for a
complete list of these side effects.
Before using Stelara, contact your doctor

• If you have ever had an allergic reaction to Stelara. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants such as Stelara partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you have ever had an allergic reaction to latex or to the Stelara injection – the container of this medicinal product contains latex, which may cause severe allergic reactions in people who are sensitive to latex. See “Be aware of serious side effects” in section 4 for signs of an allergic reaction.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The concomitant use of these therapies with Stelara has not been

studied. However, it may increase the likelihood of conditions related to immune system weakening.

• If you are using or have ever used injections for the treatment of allergies – it is not known whether Stelara may affect them.
• If you are 65 years of age or older – you may have an increased risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or
pharmacist before starting treatment with Stelara.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including
cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you
develop a red, raised, scaly rash, sometimes with a darker border, in sun-exposed areas of skin or if you
experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with Stelara, heart attacks and strokes were observed. Your
doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately
managed. Seek immediate medical attention if you develop chest pain, weakness or a numb sensation
on one side of the body, facial drooping, or speech or vision disturbances.
Children and adolescents
The Stelara pre-filled pen is not recommended for use in children and adolescents under 18 years of
age with psoriasis or Crohn’s disease, as it has not been studied in this age group. For children from
6 years of age (and adolescents) with psoriasis, the pre-filled syringe or vial should be used instead. For
children with Crohn’s disease weighing at least 40 kg, the infusion solution, vial, or pre-filled syringe
should be used instead.
Stelara is not recommended for the treatment of children and adolescents under 18 years of age with
psoriatic arthritis or ulcerative colitis, or for children with Crohn’s disease weighing less than 40 kg, as
it has not been studied in these age groups.
Other medicines, vaccines and Stelara
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are about to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Stelara.
• if you received Stelara during pregnancy, inform your child’s paediatrician about the Stelara treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Stelara during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• In newborns exposed to Stelara in the womb, no increased risk of congenital malformations has been observed. However, experience with Stelara in pregnant women is limited. Therefore, it is preferable to avoid using Stelara during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Stelara and for at least 15 weeks after stopping Stelara treatment.
• Stelara can pass to the unborn child through the placenta. If you received Stelara during pregnancy, your child may have an increased risk of developing an infection.
• If you received Stelara during pregnancy, it is important that you inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Stelara during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Stelara. You cannot do both.

Driving and using machines
Stelara has no or negligible effect on the ability to drive vehicles or operate machinery.
Stelara contains polysorbate 80
STELARA contains 0.02 mg of polysorbate 80 (E433) per dose, equivalent to 0.04 mg/mL. Polysorbates
may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Stelara

Stelara is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Stelara is indicated.
Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor. Discuss with your doctor when you should receive your injections and follow-up visits.

How much Stelara is administered

Your doctor will decide how much Stelara you need and for how long.

Adults from 18 years of age

Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Stelara. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease or ulcerative colitis

• During treatment, the first dose of approximately 6 mg/kg of Stelara is administered by your doctor as an intravenous infusion (IV infusion) into a vein in your arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Stelara, followed by subcutaneous injections (under the skin) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Stelara may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Stelara is administered

Stelara is administered by subcutaneous injection ("subcutaneously").
At the beginning of treatment, medical or nursing staff may administer Stelara to you.

• However, you and your doctor may decide whether you can self-inject Stelara. In this case, you will be trained on how to inject Stelara yourself.
• For instructions on how to inject Stelara, see “Instructions for administration” at the end of this leaflet. Inform your doctor if you have any questions about self-injection.

If you use more Stelara than you should

If you have used or received too much Stelara, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.

If you forget to use Stelara

If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.

If you stop using Stelara

Stopping treatment with Stelara is not dangerous. However, if you discontinue treatment, your symptoms may return.

If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Some patients may experience serious side effects that may require treatment.
Allergic reactions – these may require urgent treatment, so contact your doctor or seek
immediate medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking Stelara (affecting up to 1 in 1,000 patients). Signs include: difficulty breathing or swallowing, low blood pressure (which may cause dizziness or lightheadedness), or swelling of the face, lips, mouth, or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

Allergic lung reactions and lung inflammation have been reported rarely in patients receiving
ustekinumab. Inform your doctor immediately if you develop symptoms such as cough,
shortness of breath, or fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use Stelara again.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice
any of the following signs.

• Nasal, throat infections, and common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Stelara may reduce your body's ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis bacteria), or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.
You should be aware of signs of infection while using Stelara. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning when urinating
• diarrhoea
• visual disturbance or loss of vision
• headache, neck stiffness, light sensitivity, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be symptoms of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which can have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Stelara until the infection resolves. Also, inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be
symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions.
If you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching, and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash on areas of skin exposed to sunlight, sometimes with joint pain).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Stelara

• Keep this medicine out of the sight and reach of children.
• Store in the refrigerator (2°C - 8°C). Do not freeze.
• Keep the pre-filled pen in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled pens of Stelara may also be stored at room temperature up to 30°C for a single period of up to 30 days, remaining in the outer packaging to protect them from light. Record the date when the pre-filled pen is first removed from the refrigerator and the date when it should be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiration date printed on the packaging. Once a pre-filled pen has been stored at room temperature (up to 30°C), it must not be returned to the refrigerator. Dispose of the pre-filled pen if it is not used within 30 days at room temperature or by the original expiration date, whichever comes first.
• Do not shake the Stelara pre-filled pens. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton following EXP or "Scad". The expiry date refers to the last day of the month.
• If the liquid has changed colour, is cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of Stelara and contents of the pack”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been shaken vigorously.

Stelara is for single use only. Any unused product remaining in the pre-filled pen must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. OTHER INFORMATION

What Stelara contains

• The active substance is ustekinumab. Each pre-filled pen contains 45 mg of ustekinumab in 0.5 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Stelara and contents of the pack

Stelara is a solution for injection that ranges from clear to slightly opalescent (pearl-like appearance), colourless to pale yellow. The solution may contain a few small translucent or white protein particles. It is supplied in a cardboard pack containing one single dose in a 1 mL glass pre-filled pen. Each pre-filled pen contains one dose of ustekinumab 45 mg in 0.5 mL of solution for injection.

Marketing Authorisation Holder

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer

Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: +32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD.
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor hf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Tηλ: +357 22 207 700 Tfn +46 8 626 50 00
[email protected]

Latvija United Kingdom (Northern Ireland)
UAB "JOHNSON & JOHNSON" filiāle Janssen Sciences Ireland UC
Latvijā Tel: +44 1 494 567 444
Tel: +371 678 93561 [email protected]
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Instructions for use

Stelara

(ustekinumab)
Injection, for subcutaneous use
Prefilled Pen

These “Instructions for Use” contain information on how to inject Stelara.
Important
Stelara is available in a single-dose prefilled pen containing either a 45 mg dose or a 90 mg dose.
To inject the full dose during administration, push the grip all the way down until the purple
plunger is no longer visible. DO NOT LIFT THE PREFILLED PEN DURING INJECTION!
Otherwise, the prefilled pen will lock and the full dose cannot be injected.
If your doctor determines that you or a caregiver may be able to administer your Stelara injections at home, you must receive training on the correct way to prepare and inject Stelara using the prefilled pen. Do not attempt to self-inject this medicine until you have been trained by your doctor.
Each prefilled pen can only be used once. Dispose of it after use (see step 3), even if medicine remains inside.
Do not reuse the prefilled pen.
Read these Instructions for Use before using the Stelara prefilled pen and each time you receive a new prefilled pen. There may be new information. This document does not replace discussions with your doctor about your medical condition or treatment.
If you are unable to administer the injection yourself:

• ask your doctor or nurse for help, or
• ask someone who has been trained by a doctor or nurse to administer the injections to you.

To reduce the risk of accidental needle sticks, each prefilled pen has a needle shield that automatically covers and locks over the needle once the injection is complete and the pen is lifted. Do not lift the prefilled pen during injection until the injection is fully complete.
The needle cap inside the lower cap of the prefilled pen contains latex. Do not handle the needle cap if you are allergic to latex.
Also, please read the Patient Information Leaflet carefully before starting the injection and discuss any questions you may have with your doctor or nurse.

Storage Information
Store in the refrigerator at 2°C – 8°C. If necessary, store at room temperature protected from light and below 30°C for up to 30 days. Do not return to the refrigerator once stored at room temperature.
Do not freeze the prefilled pen.
Keep the prefilled pen and all medicines out of the reach of children.
Do not shake the prefilled pen. The Stelara medicine may be damaged if shaken. Do not use the prefilled pen if it has been shaken. Obtain a new prefilled pen.
Store the prefilled pen in its outer packaging to protect it from light and physical damage.

Need help?
Call your doctor to discuss any questions you may have. For further assistance or to share your feedback, refer to the Patient Information Leaflet for contact details of the local representative.
Parts of the prefilled pen for injection

1. Preparation for Stelara Injection

Prepare the carton package(s)
If stored in the refrigerator, remove the pre-filled pen(s) from the refrigerator and place them on a flat surface.
Allow to sit at room temperature for at least 30 minutes before use.
Do not heat it in any other way.
If your dose is 45 mg, you will receive one 45 mg pre-filled pen.
If your dose is 90 mg, you will receive either one 90 mg pre-filled pen or two 45 mg pre-filled pens.
If you receive two 45 mg pre-filled pens, follow steps 1 to 3 for both injections.
Choose a different injection site for the second injection.

Check the expiration date (“Exp.”) and seals on the carton package(s)
Do not use the pre-filled pen if the seals on the package are broken or if the expiration date has passed.
Do not use the pre-filled pen if it has been stored at room temperature for longer than 30 days or at a temperature above 30°C. Contact your doctor or pharmacist for a new pre-filled pen.

Choose an injection site
Select one of the following areas for injection:

• front of the thighs
• lower abdomen (excluding an area within a 5 cm radius around the navel)
  If someone else is administering the injection, the following area may also be used:
• back of the upper arms

Do not inject the solution into areas of skin that are painful, bruised, red, or hardened.
Use a different injection site for each injection.

Wash your hands
Wash your hands thoroughly with soap and lukewarm water.
Clean the injection site
Clean the chosen injection site with an alcohol swab and allow it to dry.
Do not touch, fan, or blow on the injection site after cleaning.

Inspect the liquid in the viewing window
Choose a clean, flat, and well-lit work surface.
Remove the pre-filled pen from its packaging and check for any damage.
Inspect the liquid in the viewing window. It should be from clear to slightly opalescent and colorless to pale yellow, and may contain small white or transparent particles and one or more air bubbles. This is normal.
Do not administer the injection if the liquid is frozen, cloudy, discolored, or contains large particles. Contact your doctor or pharmacist to obtain another pre-filled pen.

2. Stelara Injection

Remove the lower cap
Once the cap has been removed, do not touch the needle shield. It is normal to see a few drops
of liquid.
Inject Stelara within 5 minutes after removing the cap.
Do not reattach the cap. This could damage the needle.
Do not use a pre-filled pen if it has been dropped after removing the cap. Contact your doctor or
pharmacist to obtain another pre-filled pen.

Hold the pen vertically against the skin. Push the plunger all the way down until the
purple cylinder is completely gone.
DO NOT LIFT THE PRE-FILLED PEN during injection!
Doing so will cause the needle shield to lock, showing a yellow stripe, and the full dose
will not be delivered.
You may hear a click when the injection starts. Continue pressing.
If you feel resistance, keep pushing. This is normal.
The medicine is injected as you press down. Administer the injection at a speed that is comfortable for you.

click
Confirmation that the injection is complete
The injection is complete when:

• The purple cylinder is no longer visible.
• The plunger cannot be pressed further.
• You may hear a click.

Lift the pen upward
The yellow stripe indicates that the needle shield is locked in place.

3. After the injection

Disposal of the prefilled pen
Place the used prefilled pen into a sharps disposal container immediately after use.
Do not dispose of (throw away) used prefilled pens in household waste.
Do not recycle the used sharps disposal container.

Checking the injection site
There may be a small amount of blood or liquid at the injection site. This is normal. Press a cotton ball or gauze pad against the injection site until any bleeding stops.
Do not rub the injection site.
If needed, cover the injection site with a plaster (bandage).
If you are receiving two 45 mg prefilled pens for a 90 mg dose, repeat steps 1 to 3 with the second prefilled pen. Choose a different injection site for the second injection.

Package leaflet: Information for the user

STELARA 90 mg solution for injection in a pre-filled pen

ustekinumab
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet is intended for people who are taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Stelara is and what it is used for
2. What you need to know before using Stelara
3. How to use Stelara
4. Possible side effects
5. How to store Stelara
6. Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is
Stelara contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognise and bind to specific target proteins in the body.
Stelara belongs to a group of medicines called "immunosuppressants". These medicines partially reduce the activity of the immune system.

What Stelara is used for
Stelara administered via a pre-filled pen is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults
• moderate to severe ulcerative colitis in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Stelara will reduce inflammation and other signs of the disease.
Stelara administered via a pre-filled pen is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate or phototherapy, or in whom these treatments are ineffective.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis.
If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these treatments, you may be given Stelara to:

• reduce the signs and symptoms of the disease
• improve physical function
• slow down joint damage

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medications. If you do not respond sufficiently or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory bowel disease. If you have ulcerative colitis, you will first be treated with other medicines. If you do not respond sufficiently or are intolerant to these medicines, Stelara may be given to reduce the signs and symptoms of your disease.

2. What you should know before using Stelara

Do not use Stelara

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or
pharmacist before using Stelara.
Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check your health status
before each treatment. Make sure to inform your doctor, before each treatment, about any illnesses you
have. Additionally, inform your doctor if you have recently been in contact with people who might have
had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering
Stelara to you. If your doctor believes you are at risk of tuberculosis, you may be given medication to
treat tuberculosis.
Be aware of serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You should be alert to
certain signs of illness while taking Stelara. See “Serious side effects” in section 4 for a complete list of
these side effects.
Before using Stelara, contact your doctor

• If you have ever had an allergic reaction to Stelara. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Stelara partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you have ever had an allergic reaction to latex or to the Stelara injection – the container of this medicinal product contains latex, which may cause severe allergic reactions in people who are sensitive to latex. See “Be aware of serious side effects” in section 4 for signs of an allergic reaction.
• If you are receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The use of these therapies together with Stelara has not been

studied. However, it may increase the likelihood of conditions related to a weakened immune system.

• If you are using or have ever used injections for the treatment of allergies – it is not known whether Stelara may affect these.
• If you are aged 65 years or older – you may have a higher chance of getting infections.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or
pharmacist before starting treatment with Stelara.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous
lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a
red, raised, scaly rash, sometimes with a darker border, on areas of skin exposed to sunlight, or if you
experience joint pain.
Heart attack and stroke
In a study of patients with psoriasis treated with Stelara, heart attacks and strokes were observed. Your
doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately
managed. Seek immediate medical attention if you develop chest pain, weakness or a strange sensation on
one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
The Stelara pre-filled pen is not recommended for use in children and adolescents under 18 years of age
with psoriasis or Crohn’s disease, as it has not been studied in this age group. For children from 6 years
of age (and adolescents) with psoriasis, the pre-filled syringe or vial should be used instead. For children
with Crohn’s disease weighing at least 40 kg, the infusion solution, vial, or pre-filled syringe should be
used instead.
Stelara is not recommended for the treatment of children and adolescents under 18 years of age with
psoriatic arthritis or ulcerative colitis, or for children with Crohn’s disease weighing less than 40 kg, as
it has not been studied in these populations.
Other medicines, vaccines and Stelara
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Stelara.
• if you received Stelara during pregnancy, inform your child’s paediatrician about the Stelara treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Stelara during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• In newborns exposed to Stelara in the womb, no increased risk of congenital malformations has been observed. However, experience with Stelara in pregnant women is limited. Therefore, it is preferable to avoid using Stelara during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Stelara and for at least 15 weeks after stopping treatment with Stelara.
• Stelara can pass to the unborn child through the placenta. If you received Stelara during pregnancy, your child may have an increased risk of developing infections.
• If you received Stelara during pregnancy, it is important that you inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Stelara during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Stelara. You cannot do both.

Driving and using machines
Stelara has no or negligible effect on the ability to drive vehicles or use machinery.
Stelara contains polysorbate 80
STELARA contains 0.04 mg of polysorbate 80 (E433) per dose, equivalent to 0.04 mg/mL. Polysorbates
may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Stelara

Stelara is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Stelara is indicated.
Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor. Discuss with your doctor when you should receive injections and follow-up visits.

How much Stelara is administered

Your doctor will decide how much Stelara you need and for how long.

Adults from 18 years of age

Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Stelara. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• 4 weeks after the initial dose, you will receive the next dose, followed by subsequent doses every 12 weeks. The following doses are usually the same as the initial dose.

Crohn’s disease or ulcerative colitis

• During treatment, the first dose of approximately 6 mg/kg of Stelara is administered by your doctor through an intravenous infusion (IV infusion) into a vein in the arm. 8 weeks after the initial dose, you will receive the next dose of 90 mg of Stelara, followed by subsequent doses every 12 weeks via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Stelara may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Stelara is administered

Stelara is administered by subcutaneous injection ("subcutaneously").
At the beginning of treatment, medical or nursing staff may administer Stelara injections to you.

• However, you and your doctor may decide whether you can self-inject Stelara. In this case, you will be taught how to self-inject Stelara.
• For instructions on how to inject Stelara, see “Instructions for administration” at the end of this leaflet. Inform your doctor if you have any questions about self-injection.

If you use more Stelara than you should

If you have used or received too much Stelara, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.

If you forget to use Stelara

If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.

If you stop using Stelara

Stopping Stelara is not dangerous. However, if you discontinue treatment, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Some patients may experience serious side effects that may require treatment.

Allergic reactions – these may require urgent treatment, so contact your doctor or seek emergency medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking Stelara (affecting up to 1 in 1,000 patients). Signs include: difficulty breathing or swallowing, low blood pressure (which may cause dizziness or lightheadedness), or swelling of the face, lips, mouth, or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, or fever.

If you experience a severe allergic reaction, your doctor may decide that you should not use Stelara again.

Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections, and common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Stelara may reduce your body's ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.

You should be aware of signs of infection while taking Stelara. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• vision problems or loss of vision
• headache, neck stiffness, sensitivity to light, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of serious infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which can lead to severe complications. Contact your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Stelara until the infection resolves. Also, inform your doctor if you have any cuts or open wounds that could become infected.

Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.

Other side effects

Common side effects (affect up to 1 in 10 patients):

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients):

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients):

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression of psoriasis symptoms (erythrodermic psoriasis).
• Inflammation of small blood vessels, which may cause a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients):

• Blistering skin rash, possibly with redness, itching, and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on sun-exposed areas of skin, sometimes with joint pain).

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Stelara

• Keep this medicine out of the sight and reach of children.
• Store in the refrigerator (2°C - 8°C). Do not freeze.
• Keep the pre-filled pen in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled pens of Stelara may also be stored at room temperature up to 30°C for a single period of maximum 30 days, within the outer packaging to protect them from light. Record the date when the pre-filled pen is first removed from the refrigerator and the date it must be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a pre-filled pen has been stored at room temperature (up to 30°C), it must not be returned to the refrigerator. Discard the pre-filled pen if not used within 30 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the Stelara pre-filled pen. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after EXP or Exp. The expiry date refers to the last day of the month.
• If the solution has changed colour, is cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of Stelara and contents of the container”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been vigorously shaken.

Stelara is for single use only. Any unused product remaining in the pre-filled pen must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Stelara contains

• The active substance is ustekinumab. Each pre-filled pen contains 90 mg of ustekinumab in 1 mL.
• The other ingredients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Stelara and contents of the pack
Stelara is a solution for injection, from clear to slightly opalescent (pearl-like appearance), colourless to pale yellow. The solution may contain a few small translucent or white protein particles. It is supplied in a cardboard pack containing 1 single dose in a 1 mL glass pre-filled pen. Each pre-filled pen contains one dose of ustekinumab 90 mg in 1 mL of solution for injection.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

България (Bulgaria)
„Джонсън & Джонсън България“ ЕООД
Тел.: +359 2 489 94 00
[email protected]

Česká republika (Czech Republic)
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Danmark (Denmark)
Janssen-Cilag A/S
Tlf.: +45 4594 8282
[email protected]

Deutschland (Germany)
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955
[email protected]

Eesti (Estonia)
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
[email protected]

Ελλάδα (Greece)
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

España (Spain)
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Hrvatska (Croatia)
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]

Ísland (Iceland)
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
[email protected]

Italia (Italy)
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
[email protected]

Κύπρος (Cyprus)
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 207 700

Latvija (Latvia)
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

Lietuva (Lithuania)
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
[email protected]

Magyarország (Hungary)
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]

Malta
AM MANGION LTD.
Tel: +356 2397 6000

Nederland (Netherlands)
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Norge (Norway)
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]

Österreich (Austria)
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

Polska (Poland)
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 21 43 68 600

România (Romania)
Johnson & Johnson România SRL
Tel: +40 21 207 1800
[email protected]

Slovenija (Slovenia)
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

Slovenská republika (Slovakia)
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Suomi/Finland (Finland)
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Sverige (Sweden)
Janssen-Cilag AB
Tfn: +46 8 626 50 00
[email protected]

United Kingdom (Northern Ireland)
Janssen Sciences Ireland UC
Tel: +44 1 494 567 444
[email protected]

More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

Instructions for use

Stelara

(ustekinumab)
Injection, for subcutaneous use
Prefilled Pen

These “Instructions for Use” contain information on how to inject Stelara.
Important
Stelara is available in a single-dose prefilled pen containing either a 45 mg dose or a 90 mg dose.
To inject the full dose during administration, push the grip all the way down until the purple
cylinder is no longer visible. DO NOT LIFT THE PREFILLED PEN DURING INJECTION!
Otherwise, the prefilled pen will lock and the full dose will not be delivered.
If your doctor determines that you or someone assisting you may be able to administer your Stelara
injections at home, you must receive training on the correct way to prepare and inject Stelara using the
prefilled pen. Do not attempt to self-inject this medicine until you have been trained by your
doctor.
Each prefilled pen may be used only once. Dispose of it after use (see step 3), even if there is medicine
remaining inside.
Do not reuse the prefilled pen.
Read these Instructions for Use before using the Stelara prefilled pen and each time you receive a
new prefilled pen. There may be new information. This document does not replace discussions with
your doctor regarding your medical condition or your treatment.
If you are unable to administer the injection yourself:

• ask your doctor or nurse for help, or
• ask someone who has been trained by a doctor or nurse to administer the injections to you.

To reduce the risk of accidental needle sticks, each prefilled pen has a needle shield that automatically
covers and locks over the needle once the injection is complete and the pen is lifted. Do not lift the
prefilled pen during injection until the injection is fully complete.
The needle cap inside the lower cap of the prefilled pen contains latex. Do not handle the needle cap if
you are allergic to latex.
Also, please read the Patient Information Leaflet carefully before starting the injection and discuss any
questions you may have with your doctor or nurse.

Storage Information
Store in a refrigerator at 2°C – 8°C. If necessary, may be stored at room temperature, protected from
light, in the original carton at temperatures up to 30°C for up to 30 days. Do not refrigerate again
after storing at room temperature.
Do not freeze the prefilled pen.
Keep the prefilled pen and all medicines out of the reach of children.
Do not shake the prefilled pen. The Stelara medicine may be damaged if shaken. Do not use the
prefilled pen if it has been shaken. Obtain a new prefilled pen.
Store the prefilled pen in its outer carton to protect it from light and physical damage.

Need help?
Call your doctor to discuss any questions you may have. For further assistance or to share your
feedback, refer to the Patient Information Leaflet for contact details of the local representative.
Parts of the prefilled injection pen

1. Preparation for Stelara injection

Prepare the carton pack(s)
If stored in the refrigerator, remove the pre-filled pen pack(s) and place them on a flat surface.
Allow to reach room temperature for at least 30 minutes before use.
Do not heat in any other way.
If your dose is 45 mg, you will receive one 45 mg pre-filled pen.
If your dose is 90 mg, you will receive either one 90 mg pre-filled pen or two 45 mg pre-filled pens.
If you receive two 45 mg pre-filled pens, follow steps 1 to 3 for both injections.
Choose a different injection site for the second injection.

Check the expiry date (“Exp.”) and seals on the carton pack(s)
Do not use the pre-filled pen if the carton seals are broken or if the expiry date has passed.
Do not use the pre-filled pen if it has been stored at room temperature for longer than 30 days or at a temperature above 30°C. Contact your doctor or pharmacist for a new pre-filled pen.

Choose the injection site
Select one of the following areas for injection:

• front of the thighs
• lower abdomen (excluding an area within a 5 cm radius around the navel)
  If someone else administers the injection, you may also use:
• back of the upper arms

Do not inject the solution into areas of skin that are tender, bruised, red, or hardened.
Use a different injection site for each injection.

Wash your hands
Wash your hands thoroughly with soap and lukewarm water.
Clean the injection site
Clean the chosen injection site with an alcohol swab and allow it to dry.
Do not touch, fan, or blow on the injection site after cleaning.

Inspect the liquid in the viewing window
Choose a flat, clean, well-lit working surface.
Remove the pre-filled pen from its packaging and check for any damage.
Inspect the liquid in the viewing window. It should be from transparent to slightly opalescent and colourless to pale yellow, and may contain small white or transparent particles and one or more air bubbles. This is normal.
Do not administer the injection if the liquid is frozen, cloudy, discoloured, or contains large particles. Contact your doctor or pharmacist to obtain another pre-filled pen.

2. Stelara Injection

Remove the lower cap
Once the cap has been removed, do not touch the needle shield. It is normal to see a few drops
of liquid.
Inject Stelara within 5 minutes after removing the cap.
Do not replace the cap. This could damage the needle.
Do not use a pre-filled pen if it has been dropped after removing the cap. Contact your doctor or
pharmacist to obtain another pre-filled pen.

Place the pen vertically against the skin. Push the plunger all the way down until the
purple plunger rod is completely hidden.
DO NOT LIFT THE PRE-FILLED PEN during injection!
Doing so will cause the needle shield to lock, showing a yellow stripe, and the full dose
will not be delivered.
You may hear a click when the injection starts. Continue pressing.
If you feel resistance, keep pushing. This is normal.
The medicine is injected as you press down. Perform the injection at a speed that is comfortable for you.

click
Confirmation that the injection is complete
The injection is complete when:

• The purple plunger rod is no longer visible.
• The plunger cannot be pressed further.
• You may hear a click.

Lift the pen upward
The yellow stripe indicates that the needle shield is locked in place.

3. After Injection

Disposal of the prefilled pen
Place the used prefilled pen into a sharps disposal container immediately after use.
Do not dispose of (throw away) used prefilled pens in household waste.
Do not recycle the used sharps disposal container.

Checking the injection site
There may be a small amount of blood or liquid at the injection site. This is normal. Press a cotton ball or gauze pad over the injection site until any bleeding stops.
Do not rub the injection site.
If needed, cover the injection site with a plaster (bandage).
If you receive two 45 mg prefilled pens for a 90 mg dose, repeat steps 1 to 3 with the second prefilled pen. Choose a different injection site for the second injection.