DARZALEX

Package leaflet: Information for the patient

DARZALEX 20 mg/mL concentrate for solution for infusion

daratumumab
Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What DARZALEX is and what it is used for

What DARZALEX is
DARZALEX is an anti-cancer medicine that contains the active substance daratumumab. It
belongs to a group of medicines called "monoclonal antibodies". Monoclonal antibodies
are proteins designed to recognise and bind to a specific target in the body. Daratumumab has been designed to target specific cancer cells in the body, enabling the immune system to destroy the cancer cells.
What DARZALEX is used for
DARZALEX is used in adult patients over 18 years of age who have a type of bone marrow cancer called "multiple myeloma".

2. What you should know before using DARZALEX

Do not receive DARZALEX

• if you are allergic to daratumumab or to any of the excipients of this medicine (listed in section 6). You must not receive DARZALEX if this applies to you. If you are unsure, speak with your doctor or nurse before receiving DARZALEX.

Warnings and precautions
Talk to your doctor or nurse before receiving DARZALEX.
Infusion-related reactions
DARZALEX is administered by intravenous infusion (drip). Medicines will be given to you before and after each DARZALEX infusion to reduce the likelihood of infusion-related reactions (see "Medicines given during treatment with DARZALEX" in section 3). These reactions may occur during the infusion or within 3 days after the infusion.
In some cases, a serious allergic reaction may occur, including swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing, or a rash causing itching (urticaria). Some severe allergic reactions and other infusion-related reactions have led to death.
If you experience any of the infusion-related reactions or symptoms listed in section 4, contact your doctor or nurse immediately.
If you have infusion-related reactions, you may need to take additional medicines, or the infusion rate may need to be slowed or stopped. Once these reactions have resolved or improved, the infusion may resume.
These reactions are more likely to occur with the first infusion. If you have previously experienced an infusion-related reaction, it is less likely to happen again. Your doctor may decide not to use DARZALEX if you have a severe infusion reaction.

Reduction in blood cell counts
DARZALEX may reduce the number of white blood cells, which help fight infections, and blood cells called platelets, which help blood to clot. Inform your healthcare provider if you develop signs of infection such as fever, or signs of low platelet count such as bruising (ecchymosis) or bleeding.

Blood transfusions
If you require a blood transfusion, a test will first be performed to check your blood group. DARZALEX may interfere with this type of test. Inform the person performing the test that you are receiving DARZALEX.

Hepatitis B
Inform your doctor if you have ever had, or think you may currently have, hepatitis B infection, as DARZALEX could cause reactivation of the hepatitis B virus. Your doctor will monitor for signs of this infection before, during, and for some time after treatment with DARZALEX. Inform your doctor immediately if you develop worsening fatigue or yellowing of the skin or whites of the eyes.

Children and adolescents
DARZALEX must not be used in children or adolescents under 18 years of age, as the effects of the medicine in these age groups are unknown.

Other medicines and DARZALEX
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, and herbal preparations.

Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before receiving DARZALEX.
If you become pregnant during treatment with this medicine, inform your doctor or nurse immediately. You and your doctor will decide together whether the benefit of receiving the medicine outweighs the risk to the unborn child.

Contraception
Women receiving DARZALEX must use effective contraceptive methods during treatment and for 3 months after treatment.

Breast-feeding
You and your doctor will decide whether the benefits of breast-feeding outweigh the risks to the infant, as the medicine may pass into breast milk and it is unknown how the medicine will affect the newborn.

Driving and using machines
You may feel tired after receiving DARZALEX, which may affect your ability to drive or operate machinery.

DARZALEX contains sorbitol
Sorbitol is a source of fructose. If you suffer from hereditary fructose intolerance, a rare genetic disorder, you must not take this medicine. Patients with hereditary fructose intolerance cannot properly metabolize fructose, and its accumulation may cause serious side effects.
If you have hereditary fructose intolerance, you must inform your doctor before taking this medicine.

DARZALEX contains polysorbate
This medicine contains 0.4 mg of polysorbate 20 per mL, equivalent to 2.0 mg/vial in a 5 mL vial. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.
This medicine contains 0.4 mg of polysorbate 20 per mL, equivalent to 8.0 mg/vial in a 20 mL vial. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How DARZALEX is used

Dosage
Your doctor will calculate the dose and administration schedule of DARZALEX. The dose of DARZALEX will be determined based on your body weight.
The standard initial dose of DARZALEX is 16 mg per kg of body weight. DARZALEX may be administered alone or in combination with other medicines used to treat multiple myeloma.
When administered alone, DARZALEX is given as follows:

• once weekly for the first 8 weeks
• then once every 2 weeks for 16 weeks
• then once every 4 weeks, as long as your health condition does not worsen.

When DARZALEX is administered together with other medicines, your doctor may adjust the interval between doses as well as the number of treatments received.
In the first week, your doctor may administer the DARZALEX dose split over two consecutive days.

How the medicine is administered
DARZALEX will be administered to you by your doctor or nurse over several hours as an intravenous infusion (“IV infusion”).

Medicines administered during DARZALEX treatment
You may be given medicines to reduce the risk of developing herpes zoster.
Before each DARZALEX infusion, you will receive medicines to reduce the risk of infusion-related reactions. These may include:

• medicines for allergic reactions (antihistamines)
• medicines for inflammation (corticosteroids)
• medicines for fever (such as paracetamol).

After each DARZALEX infusion, you will receive medicines (such as corticosteroids) to reduce the risk of infusion-related reactions.

Patients with breathing problems
If you have breathing problems such as asthma or chronic obstructive pulmonary disease (COPD), you will be given inhaled medicines to help you breathe:

• medicines that help keep the airways open (bronchodilators)
• medicines that reduce lung inflammation and irritation (corticosteroids).

If you are given more DARZALEX than you should
This medicine is administered by your doctor or nurse. In the unlikely event that you receive too much (overdose), your doctor will monitor you for any adverse effects.

If you miss your appointment to receive DARZALEX
It is very important to attend all your appointments to ensure that your treatment works properly. If you miss an appointment, schedule another one as soon as possible.
If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Infusion-related reactions
Tell your doctor or nurse immediately if you notice any of the following signs of an infusion-related reaction during or within 3 days after the infusion. You may need to take other medicines, or the infusion may need to be slowed down or stopped.
These reactions include the following symptoms:
Very common (may affect more than 1 in 10 people):

• chills
• sore throat, cough
• feeling sick (nausea)
• vomiting
• itchy, runny or stuffy nose
• shortness of breath or other breathing problems.

Common (may affect up to 1 in 10 people):

• chest pain
• dizziness or feeling faint (hypotension)
• itching
• shortness of breath.

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

• a serious allergic reaction which may include swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing, or itchy rash (hives). See section 2
• eye pain
• blurred vision.

If you experience any of these infusion-related reactions, inform your doctor or nurse immediately.
Other side effects
Very common (may affect more than 1 in 10 people):

• fever
• feeling very tired
• diarrhoea
• abdominal pain
• constipation
• loss of appetite
• difficulty sleeping
• headache
• dizziness
• nerve damage which may cause tingling, numbness or pain
• high blood pressure
• rash
• muscle spasms
• swollen hands, ankles or feet
• feeling weak
• muscle and joint pain (including back pain and chest muscle pain)
• lung infection (pneumonia)
• bronchitis
• respiratory tract infections – such as nose, sinuses or throat
• low red blood cell count carrying oxygen in the blood (anaemia)
• low white blood cell count fighting infections (neutropenia, lymphopenia, leucopenia)
• low platelet count contributing to blood clotting (thrombocytopenia)
• low potassium levels in the blood (hypokalaemia)
• unusual skin sensations (such as prickling or tingling)
• COVID-19.

Common (may affect up to 1 in 10 people):

• irregular heartbeat (atrial fibrillation)
• fluid buildup in the lungs causing shortness of breath
• urinary tract infection
• severe infection anywhere in the body (sepsis)
• dehydration
• fainting
• chills
• high blood sugar levels (hyperglycaemia)
• low calcium levels in the blood
• low levels of antibodies, called “immunoglobulins”, in the blood which help fight infections (hypogammaglobulinaemia)
• inflammation of the pancreas
• itching
• a type of herpes virus infection (cytomegalovirus infection).

Uncommon (may affect up to 1 in 100 people):

• inflammation of the liver (hepatitis).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or nurse. 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 DARZALEX

DARZALEX will be stored at the hospital or clinic.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the
vial after “Exp.”. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2 °C-8 °C). Do not freeze.
Keep the vial in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Healthcare professionals
will dispose of unused medicines appropriately. This will help protect the environment.

6. Package contents and other information

What DARZALEX contains

• The active substance is daratumumab. One mL of concentrate contains 20 mg daratumumab. Each 5 mL vial of concentrate contains 100 mg of daratumumab. Each 20 mL vial of concentrate contains 400 mg of daratumumab.
• The excipients are L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 20 (E432), sorbitol (E420) and water for injections (see “DARZALEX contains sorbitol” in section 2).

Description of the appearance of DARZALEX and contents of the pack
DARZALEX is a concentrate for solution for infusion and is a colourless to yellow liquid.
DARZALEX is supplied in a cardboard box containing 1 glass vial.
DARZALEX is also marketed as a treatment initiation pack containing 11 vials:
(6 vials x 5 mL + 5 vials x 20 mL).
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
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 ehf. 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
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]
Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

Other sources of information
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 for healthcare professionals only:

This medicinal product is for single use only.
Prepare the infusion solution using the following aseptic technique:

• Calculate the dose (mg), the total volume (mL) of DARZALEX solution required, and the number of DARZALEX vials needed based on the patient's body weight.
• Check that the DARZALEX solution is colorless or yellow. Do not use the solution if opaque particles, discoloration, or other foreign particles are present.
• Using an aseptic technique, remove from the infusion bag/container a volume of 9 mg/mL (0.9%) sodium chloride injectable solution equal to the volume of DARZALEX solution required.
• Withdraw the required amount of DARZALEX solution and dilute it to the appropriate volume by adding it to an infusion bag/container containing 9 mg/mL (0.9%) sodium chloride injectable solution. The infusion bags/containers must be made of polyvinyl chloride (PVC), polypropylene (PP), polyethylene (PE), or polyolefin blend (PP+PE). Dilution must be performed under appropriate aseptic conditions. Any unused portion remaining in the vial must be discarded.
• Gently invert the bag/container to mix the solution. Do not shake.
• Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. Since daratumumab is a protein, the diluted solution may develop very small semitransparent to white protein particles. Do not use the solution if opaque particles, discoloration, or foreign particles are visible.
• Since DARZALEX does not contain preservatives, the diluted solution must be used within 15 hours (including infusion time) at room temperature (15 °C–25 °C) and under ambient light.
• If not used immediately, the diluted solution may be stored prior to administration for up to 24 hours under refrigerated conditions (2 °C–8 °C) and protected from light. Do not freeze.
• Administer the diluted solution by intravenous infusion using an infusion set with a flow regulator and an in-line, sterile, non-pyrogenic, low-protein-binding filter made of polyethersulfone (PES) (pore size 0.22 or 0.2 micrometers). Administration sets made of polyurethane (PU), polybutadiene (PBD), PVC, PP, or PE must be used.
• DARZALEX must not be infused together with other substances in the same intravenous line.
• Do not store any unused portion of the infusion solution for later use. Unused medicinal product and waste material must be disposed of in accordance with local requirements.

Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Patient information leaflet: information for the patient

DARZALEX 1800 mg solution for injection

daratumumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What DARZALEX is and what it is used for

What DARZALEX is
DARZALEX is a medicine that contains the active substance daratumumab. It belongs to a
group of medicines called "monoclonal antibodies". Monoclonal antibodies are proteins that
have been designed to recognise and bind to a specific target in the body. Daratumumab
has been designed to target specific abnormal blood cells in the body, allowing the immune
system to destroy these cells.

What DARZALEX is used for
DARZALEX is used in adult patients over 18 years of age who have a type of bone marrow cancer called "multiple myeloma".
DARZALEX is used in adult patients aged 18 years and older who have a type of blood and bone marrow condition called "smouldering or indolent multiple myeloma" that may progress to multiple myeloma.
DARZALEX is also used in adults aged 18 years and older who have a blood disorder called "AL amyloidosis", in which abnormal blood cells produce excessive amounts of abnormal proteins that deposit in various organs, impairing their proper function.

2. What you should know before using DARZALEX

Do not receive DARZALEX

• if you are allergic to daratumumab or to any of the excipients of this medicine (listed in section 6). You must not receive DARZALEX if this applies to you. If you are unsure, speak with your doctor or nurse before receiving DARZALEX.

Warnings and precautions
Talk to your doctor or nurse before receiving DARZALEX.
Infusion-related reactions
DARZALEX is administered as a subcutaneous injection using a small needle to inject the medicine under the skin. Before and after each injection, you will be given medicines to help reduce the likelihood of infusion-related reactions (see “Medicines administered during treatment with DARZALEX” in section 3). These reactions are more likely to occur with the first injection, and most reactions happen on the same day as the injection. If you have previously experienced an infusion-related reaction, it is less likely to happen again. However, delayed reactions may occur up to 3–4 days after the injection. Your doctor may decide not to use DARZALEX if you experience a severe reaction to the injection.
In some cases, a serious allergic reaction may occur, which may include swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing or breathing, or a rash causing itching (hives). See section 4.
If you experience any of the infusion-related reactions or symptoms listed in section 4, contact your doctor or nurse immediately. If you have infusion-related reactions, you may need to take additional medicines to treat the symptoms, or the injection may need to be stopped. Once these reactions have resolved or improved, the injection may be resumed.
Reduction in blood cell counts
DARZALEX may reduce the number of white blood cells, which help fight infections, and blood cells called platelets, which help blood to clot. Inform your healthcare provider if you develop any signs of infection such as fever, or any signs of low platelet counts such as bruising or bleeding.
Blood transfusions
If you require a blood transfusion, a test will first be performed to check your blood group. DARZALEX may affect this type of test. Inform the person performing the test that you are receiving DARZALEX.
Hepatitis B
Inform your doctor if you have ever had, or think you may currently have, hepatitis B infection, as DARZALEX could cause reactivation of the hepatitis B virus. Your doctor will monitor for signs of this infection before, during, and for some time after treatment with DARZALEX. Immediately inform your doctor if you experience worsening fatigue or yellowing of the skin or whites of the eyes.
Children and adolescents
DARZALEX must not be used in children or adolescents under 18 years of age, as it is not known how the medicine works in these individuals.
Other medicines and DARZALEX
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, and herbal preparations.
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before receiving DARZALEX.
If you become pregnant during treatment with this medicine, inform your doctor or nurse immediately. You and your doctor will decide together whether the benefit of receiving the medicine outweighs the risk to the unborn child.
Contraception
Women receiving DARZALEX must use effective contraceptive methods during treatment and for 3 months after treatment.
Breast-feeding
You and your doctor will decide whether the benefits of breast-feeding outweigh the risk to the infant. This is because the medicine may pass into breast milk, and it is not known how the medicine will affect the newborn baby.
Driving and using machines
You may feel tired after receiving DARZALEX, which could affect your ability to drive or operate machinery.
DARZALEX solution for subcutaneous injection contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 15 mL, i.e., essentially ‘sodium-free’.
DARZALEX solution for subcutaneous injection contains sorbitol
Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
DARZALEX solution for subcutaneous injection contains polysorbate
This medicine contains 0.4 mg of polysorbate 20 per mL, equivalent to 6.0 mg per 15 mL vial. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How DARZALEX is used

How much is given
The dose of DARZALEX subcutaneous injection solution is 1800 mg.
DARZALEX may be given alone or together with other medicines used to treat multiple myeloma or with other medicines used to treat AL amyloidosis. DARZALEX is usually administered as follows:

• once weekly for the first 8 weeks
• then every 2 weeks for 16 weeks
• then every 4 weeks as long as your health condition does not worsen.

When DARZALEX is given together with other medicines, your doctor may modify the interval between doses as well as the number of treatments received.
How the medicine is administered
DARZALEX will be administered by a doctor or nurse as an injection under the skin (subcutaneous injection) over approximately 3–5 minutes. It is administered in the stomach area (abdomen), not in other parts of the body, and not in areas of the abdomen where the skin appears red, bruised, painful, hard, or where scars are present.
If you experience pain during the injection, the doctor or nurse may stop the injection and administer the remaining dose in another area of the abdomen.
Medicines given during treatment with DARZALEX
You may be given medicines to reduce the likelihood of developing herpes zoster.
Before each DARZALEX injection, you will receive medicines to reduce the likelihood of infusion-related reactions. These may include:

• medicines for allergic reactions (antihistamines)
• medicines for inflammation (corticosteroids)
• medicines for fever (such as paracetamol).

After each DARZALEX injection, you will receive medicines (such as corticosteroids) to reduce the likelihood of infusion-related reactions.
People with breathing problems
If you have breathing problems such as asthma or chronic obstructive pulmonary disease (COPD), you will receive inhaled medicines to help you breathe:

• medicines that help keep the airways open (bronchodilators)
• medicines that reduce lung inflammation and irritation (corticosteroids)

If you are given more DARZALEX than you should
This medicine is administered by a doctor or nurse. In the unlikely event that you are given too much (overdose), your doctor will monitor you for any adverse effects.
If you miss your appointment to receive DARZALEX
It is very important to attend all your appointments to ensure that your treatment works. If you miss an appointment, reschedule as soon as possible.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

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

Infusion-related reactions
Tell your doctor or nurse immediately if you notice any of the following symptoms within 3–4 days after the injection. You may need to take other medicines, or the injection may need to be paused or stopped.
These reactions include the following symptoms:
Very common (may affect more than 1 in 10 people):

• chills
• sore throat, cough
• feeling sick (nausea)
• vomiting
• itchy, runny or blocked nose
• feeling short of breath or other breathing problems.

Common (may affect up to 1 in 10 people):

• chest pain
• dizziness or feeling faint (hypotension)
• itching
• shortness of breath.

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

• a serious allergic reaction which may include swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing, or itchy rash (urticaria). See section 2
• eye pain
• blurred vision.

If you experience any of these infusion-related reactions, tell your doctor or nurse immediately.

Injection site reactions
With DARZALEX subcutaneous solution for injection, skin reactions may occur at or near the injection site (local reactions), including injection site reactions. These reactions are very common (may affect more than 1 in 10 people), and symptoms at the injection site may include:

• redness of the skin
• itching
• swelling, pain, bruising, rash and bleeding.

Other side effects
Very common (may affect more than 1 in 10 people):

• fever
• feeling very tired
• diarrhoea
• constipation
• abdominal pain
• loss of appetite
• difficulty sleeping
• headache
• nerve damage which may cause tingling, numbness or pain
• rash
• muscle spasms
• muscle and joint pain (including back pain and chest muscle pain)
• swollen hands, ankles or feet
• feeling weak
• lung infection (pneumonia)
• bronchitis
• respiratory tract infections – such as nose, sinuses or throat
• low number of red blood cells which carry oxygen in the blood (anaemia)
• low number of white blood cells which fight infections (neutropenia, lymphopenia, leucopenia)
• low number of a type of blood cell called platelets which help blood to clot (thrombocytopenia)
• low levels of potassium in the blood (hypokalaemia)
• COVID-19.

Common (may affect up to 1 in 10 people):

• irregular heartbeat (atrial fibrillation)
• fluid buildup in the lungs causing shortness of breath
• urinary tract infection
• severe infection anywhere in the body (sepsis)
• dehydration
• high levels of sugar in the blood (hyperglycaemia)
• low levels of calcium in the blood
• low levels of antibodies, called “immunoglobulins”, in the blood which help fight infections (hypogammaglobulinaemia)
• dizziness
• fainting
• chills
• itching
• unusual sensation on the skin (such as pricking or tingling)
• inflammation of the pancreas
• high blood pressure.

Uncommon (may affect up to 1 in 100 people):

• inflammation of the liver (hepatitis)
• a type of herpes virus infection (cytomegalovirus infection).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. 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 DARZALEX

DARZALEX solution for subcutaneous injection will be stored at the hospital or clinic.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label on the vial after “Exp.”. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the vial in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Healthcare professionals will dispose of unused medicines appropriately. This will help protect the environment.

6. Package contents and other information

What DARZALEX contains

• The active substance is daratumumab. One mL of solution contains 120 mg of daratumumab. A 15 mL vial of injectable solution contains 1800 mg of daratumumab.
• The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 20 (E432), sorbitol (E420), and water for injections (see “DARZALEX contains sodium and sorbitol” in section 2).

Description of the appearance of DARZALEX and contents of the pack
DARZALEX solution for subcutaneous injection is a liquid, colourless to yellow.
DARZALEX solution for subcutaneous injection is supplied in a cardboard box containing 1 single-use glass vial.

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

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
NL-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&ДжонсънБългария” 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 [email protected]
Tel.: +36 1 884 2858

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 ehf. 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
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

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

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

The following information is intended for healthcare professionals only:

DARZALEX subcutaneous injection solution must be administered by trained healthcare personnel.
To prevent medication errors, it is essential to check the vial label to ensure that the patient receives the correct formulation (intravenous or subcutaneous) and prescribed dose. DARZALEX injectable solution must be administered exclusively via subcutaneous injection using the prescribed dose. The subcutaneous formulation of DARZALEX is not intended for intravenous administration.
DARZALEX subcutaneous injection solution is for single use only and is ready to use.

• DARZALEX subcutaneous injection solution is compatible with polypropylene or polyethylene syringes; subcutaneous infusion sets made of polypropylene, polyethylene, or polyvinyl chloride (PVC); and stainless steel transfer and injection needles.
• DARZALEX subcutaneous injection solution should be a solution ranging from clear to opalescent and from colorless to yellow. Do not use the solution if opaque particles, discoloration, or other foreign particles are visible.
• Remove the DARZALEX subcutaneous injection solution vial from the refrigerator where it is stored (2 °C–8 °C) and allow it to equilibrate to room temperature (15 °C–30 °C). The unopened vial may be stored at room temperature and light conditions for up to 24 hours in its original packaging to protect the medicine from light. Protect from direct sunlight. Do not shake.
• Prepare the administration syringe under controlled, aseptic, and validated conditions.
• To avoid needle blockage, attach the hypodermic needle or subcutaneous infusion set to the syringe immediately before injection.

Storage of the prepared syringe

• If the syringe containing DARZALEX is not used immediately, the DARZALEX solution may be stored for up to 24 hours under refrigerated conditions followed by up to 12 hours at 15 °C–25 °C and room light conditions. If refrigerated, allow the solution to reach room temperature before administration.

Administration

• Inject 15 mL of DARZALEX subcutaneous injection solution into the subcutaneous tissue of the abdomen, approximately 7.5 cm to the right or left of the umbilicus, over approximately 3–5 minutes. Do not inject DARZALEX subcutaneous injection solution at other sites, as data are not currently available.
• Injection sites should be alternated with subsequent injections.
• DARZALEX subcutaneous injection solution must never be injected into areas where the skin shows redness, bruising, tenderness, or induration, or into areas with scarring.
• Suspend or slow the administration rate if the patient reports pain. If pain persists despite slowing the injection, a second injection site on the opposite side of the abdomen may be selected to administer the remaining dose.
• During treatment with DARZALEX subcutaneous injection solution, do not administer other subcutaneously administered medications into the same site used for DARZALEX.
• Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.

Traceability
To enhance the traceability of biological medicines, the name and batch number of the administered medicine should be clearly documented.