YESINTEK

Italy

It is used to treat plaque psoriasis (in adults and children from 6 years of age), psoriatic arthritis (in adults), and moderate to severe Crohn's disease (in adults).

Brand name YESINTEK

Dosage form solution for injection

Active substance / Dosage

ustekinumab

Prescription type Restricted prescription – dispensable on hospital or specialist prescription

ATC code

L04AC05

Registration number 052000

Manufacturer BIOSIMILAR COLLABORATIONS IRELAND LIMITED

Frequently asked questions

How is Yesintek administered?

The method depends on the condition: for Crohn's disease, the first dose is administered via intravenous infusion by a doctor, followed by subcutaneous injections. For psoriasis and psoriatic arthritis, the drug is administered via subcutaneous injection.

What are the common side effects of Yesintek?

The most frequent side effects include diarrhea, nausea, vomiting, fatigue, dizziness, headache, itching, muscle or joint pain, sore throat, sinusitis, and redness or pain at the injection site.

When should you not use this medicine?

It must not be used if you are allergic to the active substance or any of the other components, or if you have an active infection that the doctor considers significant.

What are the serious side effects to watch out for?

You must contact a doctor immediately in case of severe allergic reactions (difficulty breathing, swelling of the face or throat), signs of infection (fever, persistent cough, confusion, loss of vision), or symptoms that may indicate a heart attack or stroke (chest pain, weakness, or abnormalities in speech and vision).

Are there any special precautions regarding pregnancy or breastfeeding?

It is preferable to avoid use during pregnancy. If you are of childbearing age, it is necessary to use an appropriate contraceptive method during treatment and for at least 15 weeks after discontinuation. Regarding breastfeeding, it is necessary to consult a doctor to decide whether to breastfeed or use the drug.

How should the drug be stored?

Vials and syringes must be stored in a refrigerator between 2°C and 8°C, in the original packaging to protect them from light. Pre-filled syringes can be stored at room temperature (up to 30°C) for a maximum of 30 days.

Instructions for use

Table of contents

Yesintek 130 mg concentrate for solution for infusion
1. What Yesintek is and what it is used for
2. What you need to know before using Yesintek
3. How Yesintek will be used
4. Possible side effects
5. How to store Yesintek
6. Package contents and other information
Package leaflet: Information for the user
Yesintek 45 mg solution for injection
1. What Yesintek is and what it is used for
2. What you need to know before using Yesintek
3. How to use Yesintek
4. Possible side effects
5. How to store Yesintek
6. Package contents and other information
1. Check the number of vials and prepare materials
2. Choose and prepare the injection site
3. Prepare the dose:
4. Inject the dose
5. After the injection
6. Disposal
Package leaflet: Information for the user
Yesintek 45 mg solution for injection in pre-filled syringe
2. What you should know before using Yesintek
3. How to use Yesintek
4. Possible side effects
5. How to store Yesintek
6. OTHER INFORMATION
1. Check the number of prefilled syringes and prepare materials
2. Choose and prepare the injection site
3. Remove the needle protective cap (see Figure 5)
4. Inject the dose
5. After the injection
6. Disposal
Package leaflet: Information for the user
Yesintek 90 mg solution for injection in pre-filled syringe
1. What Yesintek is and what it is used for
2. What you need to know before using Yesintek
3. How to use Yesintek
4. Possible side effects
5. How to store Yesintek
6. Package contents and other information
1. Check the number of prefilled syringes and prepare materials
2. Choose and prepare the injection site
3. Remove the needle protective cap (see Figure 5)
4. Inject the dose
5. After the injection
6. Disposal

Package leaflet: Information for the user

Yesintek 130 mg concentrate for solution for infusion

ustekinumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You are encouraged to contribute by reporting any side effects you experience. For information on how to report side effects, see the end of section 4.
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet has been written for people who take this medicine.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
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

What Yesintek is and what it is used for
What you need to know before using Yesintek
How Yesintek will be used
Possible side effects
How to store Yesintek
Contents of the pack and other information

1. What Yesintek is and what it is used for

What Yesintek is
Yesintek contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognise and bind to specific target proteins in the body.
Yesintek belongs to a group of medicines called “immunosuppressants”. These medicines reduce the activity of the immune system.
What Yesintek is used for
Yesintek is used to treat moderate to severe Crohn’s disease in adults.
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, Yesintek may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Yesintek

Do not use Yesintek

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 which 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 Yesintek.

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

If you have ever had an allergic reaction to Yesintek – Ask your doctor if you are unsure.
If you have ever had any type of cancer – This is because immunosuppressants such as Yesintek 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 have 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 may also partially reduce immune system activity. The concomitant use of these therapies with Yesintek 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 allergy injections – It is not known whether Yesintek 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 Yesintek.
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 Yesintek, 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
Yesintek is not recommended for the treatment of children under 18 years of age with Crohn’s disease, as it has not been studied in this age group.
Other medicines, vaccines, and Yesintek
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 due to be vaccinated. Some types of vaccines (live vaccines) should not be administered while you are using Yesintek.
if you received Yesintek during pregnancy, inform your child’s paediatrician about the Yesintek treatment before your child receives any vaccines, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Yesintek during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise advised by your child’s paediatrician.

Pregnancy and breastfeeding

If you are pregnant, think you may 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 newborns exposed to Yesintek in utero. However, experience with Yesintek in pregnant women is limited. Therefore, it is preferable to avoid using Yesintek 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 Yesintek and for at least 15 weeks after stopping treatment.
Ustekinumab can cross the placenta and reach the unborn child. If you received Yesintek during pregnancy, your baby may have an increased risk of developing infections.
If you received Yesintek during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccines. If you received Yesintek 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 Yesintek. You cannot do both. Driving and using machines Yesintek does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.

Yesintek contains sodium
Yesintek contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially "sodium-free". However, before administration, Yesintek is mixed with a solution containing sodium. Speak with your doctor if you are on a low-salt diet.
Yesintek contains Polysorbate 80
This medicine contains 10.4 mg of polysorbate 80 (E 433) in each 130 mg/26 mL vial, equivalent to 0.4 mg/mL (0.6 mg/kg/day). Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How Yesintek will be used

Yesintek is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of Crohn's disease.
Your doctor will administer Yesintek 130 mg concentrate for solution for infusion to you via an intravenous drip into a vein in your arm (intravenous infusion) for at least one hour. Discuss with your doctor when you should attend injections and follow-up visits.
How much Yesintek is administered
Your doctor will decide how much Yesintek 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.

Your body weight Dose
≤ 55 kg 260 mg

55 kg to ≤ 85 kg 390 mg
85 kg 520 mg

After the initial intravenous dose, you will receive the next dose of 90 mg Yesintek as an injection under the skin (subcutaneous injection) 8 weeks later, and then every 12 weeks. How Yesintek is administered
The first dose of Yesintek for the treatment of Crohn's disease is administered by your doctor through an intravenous drip into your arm (intravenous infusion). Inform your doctor if you have any questions about the use of Yesintek.

If you forget to use Yesintek
If you forget or miss your appointment for the dose administration, contact your doctor to schedule a new appointment.
If you stop using Yesintek
It is not dangerous to stop using Yesintek. 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 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 Yesintek (affecting up to 1 in 1,000 patients). Signs include: difficulty breathing or swallowing, low blood pressure causing 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). Infusion-related reactions – If you are being treated for Crohn’s disease, your first dose of Yesintek is given by intravenous infusion (drip). Some patients have experienced severe allergic reactions during the infusion.

Allergic lung reactions and lung inflammation have been reported in rare cases 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 not use Yesintek 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 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).

Yesintek 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 occur mainly 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 Yesintek. 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 can have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop treatment with Yesintek 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
Blocked 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 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)

Blistering skin rash with possible redness, itching and pain (bullous pemphigoid).
Cutaneous lupus or lupus-like syndrome (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 Allegato V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Yesintek

Yesintek 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 the vials of Yesintek. Vigorous and prolonged 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 foreign particles are visible floating in it (see section 6 “Description of the appearance of Yesintek and contents of the container”).
If you know or suspect that 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.

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

6. Package contents and other information

What Yesintek contains

The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
The excipients are: EDTA disodium salt dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E433), sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.
This medicine contains 10.4 mg of polysorbate 80 (E 433) in each 130 mg/26 mL vial, equivalent to 0.4 mg/mL (0.6 mg/kg/day). Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

Description of the appearance of Yesintek and contents of the pack
Yesintek is a clear, colourless to pale yellow concentrate for infusion solution. It is supplied in a cardboard pack containing one single dose in a 30 mL glass vial. Each vial contains 130 mg of ustekinumab in 26 mL of concentrate for infusion solution.

Marketing Authorisation Holder
Biosimilar Collaborations Ireland Limited
Unit 35/36 Grange Parade,
Baldoyle Industrial Estate,
Dublin 13, DUBLIN
Ireland, D13
R20R

Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne
Dublin
D09 C6X8
Ireland

For further information about this medicine, please contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien Lietuva
Biocon Biologics Belgium BV Biosimilar Collaborations Ireland Limited
Tél/Tel: 0080008250910 Tel: 0080008250910

България Luxembourg/Luxemburg
Biosimilar Collaborations Ireland Limited Biocon Biologics France S.A.S
Тел: 0080008250910 Tél/Tel: 0080008250910
(Belgique/Belgien)

Česká republika Magyarország
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel.: 0080008250910

Danmark Malta
Biocon Biologics Finland OY Biosimilar Collaborations Ireland Limited
Tlf: 0080008250910 Tel.: 0080008250910

Deutschland Nederland
Biocon Biologics Germany GmbH Biocon Biologics France S.A.S
Tel: 0080008250910 Tel: 0080008250910

Eesti Norge
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Tel: 0080008250910 Tlf: +47 800 62 671

Ελλάδα Österreich
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Biocon Biologics Germany GmbH
Ι.Κ.Ε Tel: 0080008250910
Τηλ.: 0080008250910

España Polska
Biocon Biologics Spain S.L. Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910

France Portugal
Biocon Biologics France S.A.S Biocon Biologics Spain S.L.
Tel: 0080008250910 Tel: 0080008250910

Hrvatska România
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910

Ireland Slovenija
Biosimilar Collaborations Ireland Limited Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794 Tel: 0080008250910

Ísland Slovenská republika
Biocon Biologics Finland OY Biocon Biologics Germany GmbH
Sími: +345 800 4316 Tel: 0080008250910

Italia Suomi/Finland
Biocon Biologics Spain S.L. Biocon Biologics Finland OY
Tel: 0080008250910 Puh/Tel: 99980008250910

Κύπρος Sverige
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Τηλ: 0080008250910 Tel: 0080008250910

Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

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

The following information is intended for healthcare professionals only.

Traceability
To improve the traceability of biological medicines, the trade name and batch number of the administered product must be clearly recorded.

Instructions for dilution
Yesintek concentrate for infusion solution must be diluted, prepared and administered by a healthcare professional using aseptic technique.

Calculate the dose and number of Yesintek vials required based on the patient’s body weight (see section 3, Table 1). Each 26 mL vial of Yesintek contains 130 mg of ustekinumab.
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 Yesintek to be added (discard 26 mL of sodium chloride for each required Yesintek vial; for 2 vials discard 52 mL, for 3 vials discard 78 mL, for 4 vials discard 104 mL).
Withdraw 26 mL of Yesintek from each required vial and add it to the 250 mL infusion bag. The final volume in the infusion bag must be 250 mL. Mix gently.
Visually inspect the diluted solution before infusion. Do not use if visible opaque particles, discolouration or foreign particles are observed.
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.
Use a single infusion set with an in-line sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometres).
Each vial is for single use only. Any unused medicine must be disposed of in accordance with local regulations.

Storage
If necessary, the diluted infusion solution may be stored at room temperature.
The infusion must be completed within 12 hours after dilution in the infusion bag. Do not freeze. Do not refrigerate after dilution.

Package leaflet: Information for the user

Yesintek 45 mg solution for injection

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You are encouraged to contribute by reporting any side effects you experience. For information on how to report side effects, see the end of section 4.
Please read this leaflet carefully before using this medicine, as 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 needs to be given Yesintek, 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 their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Yesintek is and what it is used for
What you need to know before using Yesintek
How to use Yesintek
Possible side effects
How to store Yesintek
Contents of the pack and other information

1. What Yesintek is and what it is used for

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

What Yesintek is used for
Yesintek 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

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

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 Yesintek to:

reduce 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, Yesintek may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Yesintek

Do not use Yesintek

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 Yesintek.
Warnings and precautions
Talk to your doctor or pharmacist before using Yesintek. 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 may have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Yesintek. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat it.
Be aware of serious side effects
Yesintek can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Yesintek. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using Yesintek, contact your doctor:

If you have ever had an allergic reaction to Yesintek. Ask your doctor if you are unsure.
If you have ever had any type of cancer – because immunosuppressants such as Yesintek 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 are receiving any other type of 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 Yesintek 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 allergy injections for the treatment of allergies – it is not known whether Yesintek 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, talk to your doctor or pharmacist before starting treatment with Yesintek.
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 patients with psoriasis treated with Yesintek, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Contact a doctor immediately if you develop chest pain, weakness or an unusual sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Yesintek is not recommended for the treatment of psoriasis in children under 6 years of age, or for the treatment of children under 18 years of age with psoriatic arthritis or Crohn’s disease, as it has not been studied in these age groups.
Other medicines, vaccines and Yesintek
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 Yesintek.
if you received Yesintek during pregnancy, inform your child’s paediatrician about the Yesintek treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Yesintek during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless your child’s paediatrician recommends otherwise.

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 Yesintek in utero, no increased risk of congenital malformations has been observed. However, experience with Yesintek in pregnant women is limited. Therefore, it is preferable to avoid using Yesintek 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 Yesintek and for at least 15 weeks after stopping treatment with Yesintek.
Yesintek can cross the placenta and reach the unborn child. If you received Yesintek during pregnancy, your baby may have an increased risk of developing infections.
If you received Yesintek 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 Yesintek 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 Yesintek. You cannot do both.

Driving and use of machines
Yesintek has no effect or has a negligible effect on the ability to drive vehicles or use machinery.
Yesintek contains Polysorbate 80 (E433)
This medicine contains 0.02 mg of polysorbate 80 (E 433) in each 45 mg/0.5 ml vial, equivalent to 0.02 mg/0.5 ml (0.0003 mg/kg/day). Polysorbates may cause allergic reactions. Inform your doctor if you or your child have known allergies.

3. How to use Yesintek

Yesintek is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Yesintek 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 Yesintek is administered

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

Adults from 18 years of age

Psoriasis and psoriatic arthritis

The recommended initial dose is 45 mg of Yesintek. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
After the initial dose, you will receive the next dose 4 weeks later, and then every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease

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

Children and adolescents from 6 years of age

Psoriasis

Your doctor will calculate the correct dose, including the amount (volume) of Yesintek 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 Yesintek per kg of body weight.
If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Yesintek.
If body weight exceeds 100 kg, the recommended dose is 90 mg of Yesintek.
After the initial dose, you will receive the next dose after 4 weeks, and then every 12 weeks.

How Yesintek is administered

Yesintek is administered by subcutaneous injection (“subcutaneously”). At the beginning of treatment, medical or nursing staff may administer Yesintek to you.
However, you and your doctor may decide whether you can self-inject Yesintek. In this case, you will be trained on how to self-inject Yesintek.
For instructions on how to inject Yesintek, 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 Yesintek than you should

If you have used or received too much Yesintek, 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 Yesintek

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 Yesintek

Stopping treatment with Yesintek is not dangerous. However, if you stop 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 experiences 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 assistance if you notice any of the following signs.

Severe allergic reactions ("anaphylaxis") are rare in patients taking Yesintek (affecting up to 1 in 1,000 patients). Signs include: difficulty breathing or swallowing, low blood pressure causing 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 Yesintek.
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).

Yesintek may reduce your ability to fight infections. Some infections may become severe 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 alert for signs of infection while using Yesintek. 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 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 Yesintek 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
Blocked 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 (red, raised, scaly rash on sun-exposed areas of skin, sometimes with 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 helps provide more information on the safety of this medicine.

5. How to store Yesintek

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 Yesintek 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, appears cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Yesintek 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.
If the seal is broken.

Yesintek 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 Yesintek 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 injectable preparations.
This medicine contains 0.02 mg of polysorbate 80 (E 433) in each 45 mg/0.5 mL vial, equivalent to 0.02 mg/0.5 mL (0.0003 mg/kg/day). Polysorbates may cause allergic reactions. Inform your doctor if you or your child has any known allergies.

Description of the appearance of Yesintek and contents of the pack
Yesintek is a clear, colourless to pale yellow injectable solution. It is supplied in a cardboard pack containing one 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
Biosimilar Collaborations Ireland Limited
Unit 35/36 Grange Parade,
Baldoyle Industrial Estate,
Dublin 13, DUBLIN
Ireland, D13
R20R

Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne
Dublin
D09 C6X8
Ireland

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

België/Belgique/Belgien
Biocon Biologics Belgium BV
Tél/Tel: 0080008250910

България (Bulgaria)
Biosimilar Collaborations Ireland Limited
Тел: 0080008250910

Česká republika (Czech Republic)
Biocon Biologics Germany GmbH
Tel: 0080008250910

Danmark (Denmark)
Biocon Biologics Finland OY
Tlf: 0080008250910

Deutschland (Germany)
Biocon Biologics Germany GmbH
Tel: 0080008250910

Eesti (Estonia)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Ελλάδα (Greece)
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Ι.Κ.Ε
Τηλ.: 0080008250910

España (Spain)
Biocon Biologics Spain S.L.
Tel: 0080008250910

France
Biocon Biologics France S.A.S
Tel: 0080008250910

Hrvatska (Croatia)
Biocon Biologics Germany GmbH
Tel: 0080008250910

Ireland
Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794

Ísland (Iceland)
Biocon Biologics Finland OY
Sími: +345 800 4316

Italia (Italy)
Biocon Biologics Spain S.L.
Tel: 0080008250910

Κύπρος (Cyprus)
Biosimilar Collaborations Ireland Limited
Τηλ: 0080008250910

Latvija (Latvia)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Lietuva (Lithuania)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Luxembourg/Luxemburg (Belgique/Belgien)
Biocon Biologics France S.A.S
Tél/Tel: 0080008250910

Magyarország (Hungary)
Biosimilar Collaborations Ireland Limited
Tel.: 0080008250910

Malta
Biosimilar Collaborations Ireland Limited
Tel.: 0080008250910

Nederland (Netherlands)
Biocon Biologics France S.A.S
Tel: 0080008250910

Norge (Norway)
Biocon Biologics Finland OY
Tlf: +47 800 62 671

Österreich (Austria)
Biocon Biologics Germany GmbH
Tel: 0080008250910

Polska (Poland)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Portugal
Biocon Biologics Spain S.L.
Tel: 0080008250910

România (Romania)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Slovenija (Slovenia)
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Slovenská republika (Slovakia)
Biocon Biologics Germany GmbH
Tel: 0080008250910

Suomi/Finland (Finland)
Biocon Biologics Finland OY
Puh/Tel: 99980008250910

Sverige (Sweden)
Biocon Biologics Finland OY
Tel: 0080008250910

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://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 Yesintek. In this case, you will be taught how to self-inject Yesintek. Inform your doctor if you have any questions regarding self-injection.

Do not mix Yesintek with other injectable liquids.
Do not shake the vials of Yesintek, 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 or vials from the refrigerator. Leave the vial outside the refrigerator for about half an hour. 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 vial of Yesintek; if your dose is 90 mg, you will use two 45 mg vials of Yesintek 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 in the left thigh), and carry out the injections one after the other. Use a new needle and a new syringe for each injection.
OR
The vial must not be used and must be disposed of if:
it is not the correct medicine
the expiry date has been exceeded
the vial is damaged or the seal is broken
the solution in the vial does not appear clear, ranging from colourless to pale yellow
the solution is discoloured or cloudy and contains foreign particles
the solution has been frozen.

Children with 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 of the type of syringe required 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. The supplies should include a syringe, needle, antiseptic swabs, a cotton ball or gauze, and a sharps container (see Figure 1).

Technical drawing of a syringe with needle, a glass vial, a cotton ball, square gauze pads, and a biohazard waste container with biohazard symbol

Figure 1

2. Choose and prepare the injection site

Choose an injection site (see Figure 2).

Yesintek is administered by injection under the skin (subcutaneously).
A suitable place for the injection is the upper thigh or around the abdomen (abdominal area), at least 5 cm away from the navel.
If possible, avoid areas of skin showing signs of psoriasis.
If someone is assisting with the injection, the upper arm may also be used as an injection site.

Schematic drawing of a male torso with gray areas on the arm and abdomen, and a leg with a gray area on the thigh indicating injection sites

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).

Two glass vials with screw caps, one with the cap closed and the

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 protective needle cap.
Do not touch the needle, and do not let the needle touch anything.
Insert the needle through the rubber stopper.
Turn the vial and syringe upside down.
Pull back the syringe plunger to draw up the amount of liquid prescribed by your doctor.
It is important that the needle remains immersed in the liquid at all times to prevent air bubbles from entering the syringe (see Figure 4).

Two hands handling a syringe with the needle inserted into a glass vial to draw up liquid medication

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).

Two hands holding a syringe with the needle pointing upward

Figure 5

Then push the plunger until all the air is expelled (but not the liquid).
Do not place the syringe down, and avoid letting the needle touch anything.

4. Inject the dose

Gently pinch the clean area of skin, holding it between the thumb and index finger. Do not pinch too tightly.
Insert the needle into the pinched skin.
Push the plunger with the thumb until all the liquid is 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 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 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 and needles must be placed in a puncture-resistant container, such as a sharps container. For your health and safety and for the safety of others, never reuse needles or syringes. Dispose of the sharps container in accordance with local regulations.
Empty vials, antiseptic swabs, and other devices may be discarded in regular waste.

Package leaflet: Information for the user

Yesintek 45 mg solution for injection in pre-filled syringe

ustekinumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You are encouraged to help by reporting any side effects you observe. For information on how to report side effects, see the end of section 4.
Please read this leaflet carefully before using this medicine, as it contains important information for you.
This leaflet has been written for individuals receiving this medicine. If you are a parent or caregiver administering Yesintek 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 personally. Do not give it to others, even if their symptoms are similar to yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Yesintek is and what it is used for
What you need to know before using Yesintek
How to use Yesintek
Possible side effects
How to store Yesintek
Contents of the pack and other information

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

What Yesintek is used for
Yesintek 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)

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Yesintek will reduce inflammation and other signs of the disease.
Yesintek is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or in whom these treatments have not been effective.
Yesintek 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.

reduce 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, Yesintek may be administered to reduce the signs and symptoms of your disease.

2. What you should know before using Yesintek

Do not use Yesintek

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.

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

Before using Yesintek, contact your doctor

If you have ever had an allergic reaction to Yesintek. Ask your doctor if you are unsure.
If you have ever had any type of cancer – because immunosuppressants such as Yesintek 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 are taking 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 Yesintek 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 allergy injections for the treatment of allergies – it is not known whether Yesintek may affect them.
If you are aged 65 years or older – you may have an increased risk of developing infections.

Heart attack and stroke
In a study of psoriasis patients treated with Yesintek, 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
Yesintek is not recommended for the treatment of children under 6 years of age with psoriasis, or for children under 18 years of age with psoriatic arthritis or Crohn’s disease, as it has not been studied in these age groups.

Other medicines, vaccines, and Yesintek
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 administered while you are using Yesintek.
if you received Yesintek during pregnancy, inform your child’s paediatrician about the Yesintek treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Yesintek 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, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
In newborns exposed to Yesintek in the womb, no increased risk of congenital malformations has been observed. However, experience with Yesintek in pregnant women is limited. Therefore, it is preferable to avoid using Yesintek 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 Yesintek and for at least 15 weeks after stopping treatment with Yesintek.
Yesintek can pass to the unborn child through the placenta. If you received Yesintek during pregnancy, your child may have an increased risk of developing infections. If you received Yesintek during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Yesintek 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 plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Yesintek. You cannot do both.

Driving and using machines
Yesintek does not affect or has a negligible effect on the ability to drive or use machinery.

Yesintek contains Polysorbate 80 (E433)
This medicine contains 0.02 mg of polysorbate 80 (E 433) in each 45 mg/0.5 ml vial, equivalent to 0.02 mg/0.5 ml (0.0003 mg/kg/day). Polysorbates may cause allergic reactions. Inform your doctor if you or your child have known allergies.

3. How to use Yesintek

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

Adults from 18 years of age
Psoriasis and psoriatic arthritis

The recommended initial dose is 45 mg of Yesintek. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
After the initial dose, you will receive the next dose 4 weeks later, and then every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease

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

Children and adolescents from 6 years of age
Psoriasis

Your doctor will calculate the correct dose, including the amount (volume) of Yesintek to be injected to ensure the correct dose is administered. The correct dose will depend on the child’s body weight at the time of each administration.
A 45 mg vial is available in case a lower dose than 45 mg is required.
If body weight is below 60 kg, the recommended dose is 0.75 mg of Yesintek per kg of body weight.
If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Yesintek.
If body weight exceeds 100 kg, the recommended dose is 90 mg of Yesintek.
After the initial dose, the next dose should be administered 4 weeks later, and then every 12 weeks.

How Yesintek is administered

Yesintek is administered by subcutaneous injection (“subcutaneously”). At the beginning of treatment, medical or nursing staff may administer Yesintek to you.
However, you and your doctor may decide whether you can self-inject Yesintek. In this case, you will be trained on how to self-administer Yesintek.
For instructions on how to inject Yesintek, see “Instructions for Administration” at the end of this package leaflet. Inform your doctor if you have any questions about self-injection.

If you use more Yesintek than you should
If you have used or received too much Yesintek, 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 Yesintek
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 Yesintek
Stopping treatment with Yesintek is not dangerous. However, if you stop 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 Yesintek (affecting up to 1 in 1,000 patients). Signs include:
o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or lightheadedness, or
o 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 not use Yesintek 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).

Yesintek 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 a weakened immune system (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 Yesintek. These include:

fever, flu-like symptoms, night sweats, weight loss
feeling tired or short of breath, persistent cough
warmth, redness, pain and tenderness of 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

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
Blocked 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 (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 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 Yesintek

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 Yesintek 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 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 Yesintek. 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 Exp. The expiry date refers to the last day of the month.
After the discard date indicated on the packaging; following storage at room temperature up to 30°C for more than 30 days.
If the solution has changed colour, is cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Yesintek 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.

Yesintek 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. OTHER INFORMATION

What Yesintek contains

The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.
This medicine contains 0.02 mg of polysorbate 80 (E 433) in each 45 mg/0.5 mL vial, equivalent to 0.02 mg/0.5 mL (0.0003 mg/kg/day). Polysorbates may cause allergic reactions. Inform your doctor if you or your child has any known allergies.

Description of the appearance of Yesintek and contents of the pack

Yesintek is a clear, injectable solution, colourless to pale yellow. 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 single dose of 45 mg ustekinumab in 0.5 mL of solution for injection.

Marketing Authorisation Holder
Biosimilar Collaborations Ireland Limited
Unit 35/36 Grange
Parade,
Baldoyle Industrial Estate,
Dublin 13, DUBLIN
Ireland, D13
R20R

Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne
Dublin
D09 C6X8
Ireland

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