daratumumab: package leaflet

What DARZALEX is
DARZALEX is a cancer 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 attach to specific targets in the body. Daratumumab has been designed to attach to specific cancer cells in your body, so that your immune system can destroy the cancer cells.
What DARZALEX is used for
DARZALEX is used in adults 18 years or older, who have a type of cancer called “multiple myeloma”. This is a cancer of your bone marrow.

You must not be given DARZALEX
- if you are allergic to daratumumab or any of the other ingredients of this medicine (listed in section 6).
Do not use DARZALEX if the above applies to you. If you are not sure, talk to your doctor or nurse before you are given DARZALEX.
Warnings and precautions
Talk to your doctor or nurse before you are given DARZALEX.
Infusion-related reactions
DARZALEX is given as an infusion (drip) into a vein. Before and after each infusion of DARZALEX, you will be given medicines which help to lower the chance of infusion-related reactions (see “Medicines given during treatment with DARZALEX” in section 3). These reactions can happen during the infusion or in the 3 days after the infusion.
In some cases you may have a severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives). Some serious allergic reactions and other severe infusion-related reactions have resulted in death.

Tell your doctor or nurse straight away if you get any of the infusion-related reactions or related symptoms listed at the top of section 4.
If you get infusion-related reactions, you may need other medicines, or the infusion may need to be slowed down or stopped. When these reactions go away, or get better, the infusion can be started again.
These reactions are most likely to happen with the first infusion. If you have had an infusion-related reaction once it is less likely to happen again. Your doctor may decide not to use DARZALEX if you have a strong infusion reaction.
Decreased blood cell counts
DARZALEX can decrease white blood cell counts which help fight infections, and blood cells called platelets which help to clot blood. Tell your healthcare provider if you develop any symptoms of infection such as fever, trouble breathing, cough, burning or pain when you urinate, or any symptoms of decreased platelet counts such as bruising or bleeding.
Blood transfusions
If you need a blood transfusion, you will have a blood test first to match your blood type.
DARZALEX can affect the results of this blood test. Tell the person doing the test that you are using DARZALEX.
Hepatitis B
Tell your doctor if you have ever had or might now have a hepatitis B infection. This is because DARZALEX could cause hepatitis B virus to become active again. Your doctor will check you for signs of this infection before, during and for some time after treatment with DARZALEX. Tell your doctor right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes.
Children and adolescents
Do not give DARZALEX to children or adolescents below 18 years of age. This is because it is not known how the medicine will affect them.
Other medicines and DARZALEX
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
This includes medicines you can get without a prescription, and herbal medicines.
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
If you become pregnant while being treated with this medicine, tell your doctor or nurse straight away.
You and your doctor will decide if the benefit of having the medicine is greater than the risk to your baby.
Contraception
Women who are being given DARZALEX should use effective contraception during treatment and for 3 months after treatment.
Breast-feeding
You and your doctor will decide if the benefit of breast-feeding is greater than the risk to your baby.
This is because the medicine may pass into the mother’s milk and it is not known how it will affect the baby.
Driving and using machines
You may feel tired after taking DARZALEX which may affect your ability to drive or use machines.

DARZALEX contains sorbitol
Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects.
You must tell your doctor before receiving this medicine if you have HFI.
DARZALEX contains polysorbate
This medicine contains 0.4 mg of polysorbate 20 in each mL, which is equivalent to 2.0 mg per 5 mL vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
This medicine contains 0.4 mg of polysorbate 20 in each mL, which is equivalent to 8.0 mg per 20 mL vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

How much is given
Your doctor will work out your dose and schedule of DARZALEX. The dose of DARZALEX will depend on your body weight.
The usual starting dose of DARZALEX is 16 mg per kg of body weight. DARZALEX may be given alone or together with other medicines used to treat multiple myeloma.
When given alone, DARZALEX is given as follows:
 once a week for the first 8 weeks
 then once every 2 weeks for 16 weeks
 then once every 4 weeks after that as long as your condition does not worsen.
When DARZALEX is given together with other medicines your doctor may change the time between doses as well as how many treatments you will receive.
In the first week your doctor may give you the DARZALEX dose split over two consecutive days.
How the medicine is given
DARZALEX will be given to you by a doctor or nurse. It is given as a drip into a vein (“intravenous infusion”) over several hours.
Medicines given during treatment with DARZALEX
You may be given medicines to lower the chance of getting shingles.
Before each infusion of DARZALEX you will be given medicines which help to lower the chance of infusion-related reactions. These may include:
 medicines for an allergic reaction (anti-histamines)
 medicines for inflammation (corticosteroids)
 medicines for fever (such as paracetamol).
After each infusion of DARZALEX you will be given medicines (such as corticosteroids) to lower the chance of infusion-related reactions.
People with breathing problems
If you have breathing problems, such as asthma or Chronic Obstructive Pulmonary Disease (COPD), you will be given medicines to inhale which help your breathing problems:
 medicines to help the airways in your lungs stay open (bronchodilators)
 medicines to lower swelling and irritation in your lungs (corticosteroids).

If you are given more DARZALEX than you should
This medicine will be given by your doctor or nurse. In the unlikely event that you are given too much (an overdose) your doctor will check you for side effects.
If you forget your appointment to have DARZALEX
It is very important to go to all your appointments to make sure your treatment works. If you miss an appointment, make another one as soon as possible.
If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Infusion-related reactions
Tell your doctor or nurse straight away if you get any of the following signs of an infusion-related reaction during or in the 3 days after the infusion. You may need 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 blocked nose
 feeling short of breath or other breathing problems.
Common (may affect up to 1 in 10 people):
 chest discomfort
 dizziness or lightheadedness (hypotension)
 itching
 wheezing.
Rare (may affect up to 1 in 1000 people):
 severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives). See section 2.
 eye pain
 blurred vision.
If you get any of the infusion-related reactions above, tell your doctor or nurse straight away.
Other side effects
Very common (may affect more than 1 in 10 people):
 fever
 feeling very tired
 diarrhoea
 abdominal pain
 constipation
 decreased appetite
 difficulty sleeping
 headache
 feeling dizzy
 nerve damage that may cause tingling, numbness, or pain
 high blood pressure

 skin 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
 infections of the airways – 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 help fight infections (neutropenia, lymphopenia, leukopenia)  low number of a type of blood cell called platelets which help to clot blood (thrombocytopenia)  low level of potassium in the blood (hypokalaemia)  unusual feeling in the skin (such as a tingling or crawling feeling)  COVID-19.
Common (may affect up to 1 in 10 people):
 irregular heart beat (atrial fibrillation)
 build up of fluid in the lungs making you short of breath
 urinary tract infection
 severe infection throughout the body (sepsis)
 dehydration
 fainting
 chills
 low blood pressure
 weight loss
 high level of sugar in the blood
 low level of calcium in the blood
 low level of antibodies called ‘immunoglobulins’ in the blood which help fight infections (hypogammaglobulinaemia)  inflamed pancreas  itching  type of herpes virus infection (cytomegalovirus infection).
Uncommon (may affect up to 1 in 100 people):
 inflamed liver (hepatitis).
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 which is stated on the carton and the vial label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C-8 °C). Do not freeze.

Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.

What DARZALEX contains

The active substance is daratumumab. One mL of concentrate contains 20 mg daratumumab.
Each vial of 5 mL concentrate contains 100 mg of daratumumab. Each vial of 20 mL concentrate contains 400 mg of daratumumab.

The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20 (E432), sorbitol (E420), and water for injections (see “DARZALEX contains sorbitol” in section 2).
What DARZALEX looks like and contents of the pack
DARZALEX is a concentrate for solution for infusion and is a colourless to yellow liquid.
DARZALEX is supplied as a carton pack containing 1 glass vial.
DARZALEX is also supplied as an initiation pack containing 11 vials: (6 x 5 mL vials + 5 x 20 mL vials).
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
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: 0800 93 377 info_belux@its.jnj.com
Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88 lt@its.jnj.com
България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00 jjsafety@its.jnj.com
Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: 800 29 504 info_belux@its.jnj.com

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227
Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858 janssenhu@its.jnj.com
Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282 jacdk@its.jnj.com
Malta
AM MANGION LTD
Tel: +356 2397 6000
Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955 medinfo-de@its.jnj.com
Nederland
Janssen-Cilag B.V.
Tel: 0800 242 42 42 info_nl@its.jnj.com
Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410 ee@its.jnj.com
Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00 jacno@its.jnj.com
Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000
Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300
España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00 contacto@its.jnj.com
Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00
France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 medisource@its.jnj.com
Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600
Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
România
Johnson & Johnson România SRL
Tel: +40 21 207 1800
Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122 medinfo@its.jnj.com
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
JNJ-SI-safety@its.jnj.com
Ísland
Janssen-Cilag AB c/o Vistor ehf.
Sími: +354 535 7000 janssen@vistor.is
Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400
Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com
Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300 jacfi@its.jnj.com

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700
Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00 jacse@its.jnj.com
Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561 lv@its.jnj.com
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.
--------------------------------------------------------------------------------------------------------------------------- The following information is intended for healthcare professionals only:
This medicinal product is for single-use only.
Prepare the solution for infusion using aseptic technique as follows:

Calculate the dose (mg), total volume (mL) of DARZALEX solution required and the number of DARZALEX vials needed based on patient weight.

Check that the DARZALEX solution is colourless to yellow. Do not use if opaque particles, discolouration or other foreign particles are present.

Using aseptic technique, remove a volume of sodium chloride 9 mg/mL (0.9%) solution for injection from the infusion bag/container that is equal to the required volume of DARZALEX solution.

Withdraw the necessary amount of DARZALEX solution and dilute to the appropriate volume by adding to an infusion bag/container containing sodium chloride 9 mg/mL (0.9%) solution for injection. Infusion bags/containers must be made of polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE) or polyolefin blend (PP+PE). Dilute under appropriate aseptic conditions. Discard any unused portion left in the vial.

Gently invert the bag/container to mix the solution. Do not shake.

Visually inspect parenteral medicinal products for particulate matter and discolouration prior to administration. The diluted solution may develop very small, translucent to white proteinaceous particles, as daratumumab is a protein. Do not use if visibly opaque particles, discolouration or foreign particles are observed.

Since DARZALEX does not contain a preservative, diluted solutions should be administered within 15 hours (including infusion time) at room temperature (15 °C-25 °C) and in room light.

If not used immediately, the diluted solution can be stored prior to administration for up to 24 hours at refrigerated conditions (2 °C-8 °C) and protected from light. Do not freeze.

Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.22 or 0.2 micrometre). Polyurethane (PU), polybutadiene (PBD), PVC, PP or PE administration sets must be used.

Do not infuse DARZALEX concomitantly in the same intravenous line with other agents.

Do not store any unused portion of the infusion solution for reuse. Any unused product or waste material should be disposed of in accordance with local requirements.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

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 attach to specific targets in the body. Daratumumab has been designed to attach to specific abnormal blood cells in your body, so that your immune system can destroy these cells.
What DARZALEX is used for
DARZALEX is used in adults 18 years or older, who have a type of cancer called “multiple myeloma”. This is a cancer of your bone marrow.
DARZALEX is used in adults 18 years or older, who have a type of blood and bone marrow disorder called “smouldering multiple myeloma” that can become multiple myeloma.
DARZALEX is also used in adults 18 years or older, who have a type of blood disorder called “AL amyloidosis.” In AL amyloidosis, abnormal blood cells make excessive amounts of abnormal proteins that deposit in various organs, causing these organs to not function properly.

You must not be given DARZALEX
- if you are allergic to daratumumab or any of the other ingredients of this medicine (listed in section 6).
Do not use DARZALEX if the above applies to you. If you are not sure, talk to your doctor or nurse before you are given DARZALEX.
Warnings and precautions
Talk to your doctor or nurse before you are given DARZALEX.

Infusion-related reactions
DARZALEX is given as a subcutaneous injection using a small needle to inject the medicine under your skin. Before and after each injection, you will be given medicines which help to lower the chance of infusion-related reactions (see “Medicines given during treatment with DARZALEX” in section 3).
These reactions are most likely to happen with the first injection and most reactions occur on the day of injection. If you have had an infusion-related reaction once it is less likely to happen again.
However, delayed reactions can happen up to 3-4 days after the injection. Your doctor may decide not to use DARZALEX if you have a strong reaction after the injection.
In some cases you may have a severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives). See section 4.
Tell your doctor or nurse straight away if you get any of the infusion-related reactions or related symptoms listed at the top of section 4. If you get infusion-related reactions, you may need other medicines to treat your symptoms, or the injections may need to be stopped. When these reactions go away, or get better, the injection can be started again.
Decreased blood cell counts
DARZALEX can decrease white blood cell counts which help fight infections, and blood cells called platelets which help to clot blood. Tell your healthcare provider if you develop any symptoms of infection such as fever, trouble breathing, cough, burning or pain when you urinate, or any symptoms of decreased platelet counts such as bruising or bleeding.
Blood transfusions
If you need a blood transfusion, you will have a blood test first to match your blood type.
DARZALEX can affect the results of this blood test. Tell the person doing the test that you are using DARZALEX.
Hepatitis B
Tell your doctor if you have ever had or might now have a hepatitis B infection. This is because DARZALEX could cause hepatitis B virus to become active again. Your doctor will check you for signs of this infection before, during and for some time after treatment with DARZALEX. Tell your doctor right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes.
Children and adolescents
Do not give DARZALEX to children or adolescents below 18 years of age. This is because it is not known how the medicine will affect them.
Other medicines and DARZALEX
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
This includes medicines you can get without a prescription, and herbal medicines.
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
If you become pregnant while being treated with this medicine, tell your doctor or nurse straight away.
You and your doctor will decide if the benefit of having the medicine is greater than the risk to your baby.
Contraception
Women who are being given DARZALEX should use effective contraception during treatment and for 3 months after treatment.
Breast-feeding
You and your doctor will decide if the benefit of breast-feeding is greater than the risk to your baby.
This is because the medicine may pass into the mother’s milk and it is not known how it will affect the baby.

Driving and using machines
You may feel tired after taking DARZALEX which may affect your ability to drive or use machines.
DARZALEX solution for subcutaneous injection contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 15 mL, that is to say 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 some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take this medicine.
DARZALEX solution for subcutaneous injection contains polysorbate
This medicine contains 0.4 mg of polysorbate 20 in each mL, which is equivalent to 6.0 mg per 15 mL vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

How much is given
The dose of DARZALEX solution for subcutaneous injection 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 given as follows:
 once a week for the first 8 weeks
 then once every 2 weeks for 16 weeks
 then once every 4 weeks after that as long as your condition does not worsen.
When DARZALEX is given together with other medicines your doctor may change the time between doses as well as how many treatments you will receive.
How the medicine is given
DARZALEX will be given to you by a doctor or nurse as an injection under your skin (subcutaneous injection) over approximately 3 to 5 minutes. It is given in the stomach area (abdomen), not in other sites of the body, and not into areas of the abdomen where the skin is red, bruised, tender, hard or where there are scars.
If you experience pain during the injection, the doctor or nurse may interrupt the injection and give you the remaining injection in another area of your abdomen.
Your doctor will decide if you or your caregiver can administer DARZALEX after proper training.
Always use this medicine exactly as the doctor or nurse has told you. Check with the doctor, pharmacist or nurse if you are not sure. If you feel unwell talk to your doctor or pharmacist. Talk to your doctor about when you will have your injections and follow-up appointments.
Medicines given during treatment with DARZALEX
You may be given medicines to lower the chance of getting shingles.
Before each injection of DARZALEX you will be given medicines which help to lower the chance of infusion-related reactions. These may include:
 medicines for an allergic reaction (anti-histamines)
 medicines for inflammation (corticosteroids)
 medicines for fever (such as paracetamol).

After each injection of DARZALEX you will be given medicines (such as corticosteroids) to lower the chance of infusion-related reactions.
People with breathing problems
If you have breathing problems, such as asthma or Chronic Obstructive Pulmonary Disease (COPD), you will be given medicines to inhale which help your breathing problems:
 medicines to help the airways in your lungs stay open (bronchodilators)
 medicines to lower swelling and irritation in your lungs (corticosteroids).
If you are given more DARZALEX than you should
This medicine will be given by your doctor or nurse. In the unlikely event that you are given too much (an overdose) your doctor will check you for side effects.
If you forget your appointment to have DARZALEX
It is very important to go to all your appointments to make sure your treatment works. If you miss an appointment, make another one as soon as possible.
If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Infusion-related reactions
Tell your doctor or nurse straight away if you get any of the following symptoms within 3-4 days after the injection. You may need other medicines, or the injection may need to be interrupted 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 discomfort
 dizziness or lightheadedness (hypotension)
 itching
 wheezing.
Rare (may affect up to 1 in 1000 people):
 severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives). See section 2.
 eye pain
 blurred vision.
If you get any of the infusion-related reactions above, tell your doctor or nurse straight away.
Injection site reactions
Skin reactions at or near the injection site (local), including injection site reactions, can happen with DARZALEX solution for subcutaneous injection. These reactions are very common (may affect more than 1 in 10 people). Symptoms at the site of injection may include redness of the skin, itching, swelling, pain, bruising, rash, bleeding.

Other side effects
Very common (may affect more than 1 in 10 people):
 fever
 feeling very tired
 diarrhoea
 constipation
 abdominal pain
 decreased appetite
 difficulty sleeping
 headache
 nerve damage that 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
 infections of the airways – 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 help fight infections (neutropenia, lymphopenia, leukopenia)  low number of a type of blood cell called platelets which help to clot blood (thrombocytopenia)  low level of potassium in the blood (hypokalaemia)  COVID-19.
Common (may affect up to 1 in 10 people):
 irregular heart beat (atrial fibrillation)
 build up of fluid in the lungs making you short of breath
 urinary tract infection
 severe infection throughout the body (sepsis)
 dehydration
 high level of sugar in the blood
 low level of calcium in the blood
 low level of antibodies called ‘immunoglobulins’ in the blood which help fight infections (hypogammaglobulinaemia)  feeling dizzy  fainting  chills  itching  unusual feeling in the skin (such as a tingling or crawling feeling)  inflamed pancreas  high blood pressure  low blood pressure  weight loss.
Uncommon (may affect up to 1 in 100 people):
 inflamed liver (hepatitis)
 type of herpes virus infection (cytomegalovirus infection).
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C-8 °C). Do not freeze.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.

What DARZALEX contains

The active substance is daratumumab. One mL of solution contains 120 mg daratumumab. One vial of 15 mL solution for injection contains 1800 mg of daratumumab.

The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20 (E432), sorbitol (E420), and water for injections (see “DARZALEX contains sodium and sorbitol” in section 2).
What DARZALEX looks like and contents of the pack
DARZALEX solution for subcutaneous injection is a colourless to yellow liquid.
DARZALEX solution for subcutaneous injection is supplied as a carton pack containing 1 single-dose 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
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: 0800 93 377 info_belux@its.jnj.com
Lietuva
UAB “JOHNSON & JOHNSON”
Tel: +370 5 278 68 88 lt@its.jnj.com
България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00 jjsafety@its.jnj.com
Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: 800 29 504 info_belux@its.jnj.com
Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227
Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858 janssenhu@its.jnj.com
Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282 jacdk@its.jnj.com
Malta
AM MANGION LTD
Tel: +356 2397 6000
Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955 medinfo-de@its.jnj.com
Nederland
Janssen-Cilag B.V.
Tel: 0800 242 42 42 info_nl@its.jnj.com
Eesti
UAB “JOHNSON & JOHNSON” Eesti filiaal
Tel: +372 617 7410 ee@its.jnj.com
Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00 jacno@its.jnj.com
Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000
Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300
España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00 contacto@its.jnj.com
Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00
France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 medisource@its.jnj.com
Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600
Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122 medinfo@its.jnj.com
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
JNJ-SI-safety@its.jnj.com
Ísland
Janssen-Cilag AB c/o Vistor ehf.
Sími: +354 535 7000 janssen@vistor.is
Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400
Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com
Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300 jacfi@its.jnj.com
Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700
Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00 jacse@its.jnj.com
Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561 lv@its.jnj.com
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.
--------------------------------------------------------------------------------------------------------------------------- The following information is intended for healthcare professionals only:
DARZALEX solution for subcutaneous injection should be administered by a healthcare professional.
To prevent medication errors, it is important to check the vial labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) and dose is being given to the patient as prescribed. DARZALEX solution for injection should be given by subcutaneous injection only, using the dose specified. DARZALEX subcutaneous formulation is not intended for intravenous administration.
DARZALEX solution for subcutaneous injection is for single use only and is ready to use.

DARZALEX solution for subcutaneous injection is compatible with polypropylene or polyethylene syringe material; polypropylene, polyethylene, or polyvinyl chloride (PVC) subcutaneous infusion sets; and stainless steel transfer and injection needles.

DARZALEX solution for subcutaneous injection should be a clear to opalescent and colourless to yellow solution. Do not use if opaque particles, discolouration or other foreign particles are present.

Remove the DARZALEX solution for subcutaneous injection vial from refrigerated storage (2 °C – 8 °C) and equilibrate to ambient temperature (15 °C–30 °C). The unpunctured vial may be stored at ambient temperature and ambient light for a maximum of 24 hours in the original carton to protect from light. Keep out of direct sunlight. Do not shake.

Prepare the dosing syringe in controlled and validated aseptic conditions. Withdraw 15 mL from the vial into a syringe using an 18G - 22G transfer needle with a regular bevel to minimise the

risk of stopper coring. Insert the needle into the vial at a 90°angle within the ring of the stopper and minimise the number of punctures to prevent fragmentation of the stopper. Inspect the content of the syringe to ensure the absence of particulate matter, discolouration or other foreign particles.

To avoid needle clogging, attach the hypodermic injection needle or subcutaneous infusion set to the syringe immediately prior to injection.
Storage of prepared syringe

If the syringe containing DARZALEX is not used immediately, store the solution of DARZALEX for up to 24 hours refrigerated followed by up to 12 hours at 15 °C-25 °C and ambient light. If stored in the refrigerator, allow the solution to reach ambient temperature before administration.
Administration

Inject 15 mL DARZALEX solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3- 5 minutes. Do not inject DARZALEX solution for subcutaneous injection at other sites of the body as no data are available.

Injection sites should be rotated for successive injections.

DARZALEX solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars.

Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose.

During treatment with DARZALEX solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as DARZALEX.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

The following information is intended for Patients and Caregivers only:
Instructions for Use
Your healthcare provider will administer the initial injections of DARZALEX subcutaneously (under the skin), hereafter referred to as DARZALEX. Afterwards you and your doctor may decide that you or a caregiver may inject DARZALEX. If this happens, you or a caregiver will get training from your healthcare provider on how to prepare and inject DARZALEX. Talk to your doctor if you have any questions about giving yourself an injection.
Storage
Storage of unopened vial
Store in refrigerator at 2 °C to 8 °C. Once the vial of DARZALEX is removed from the refrigerator, it should not be returned to the refrigerator.
Keep the medication out of the sight and reach of children.
Supplies
You will need:
You will also need:
• Antiseptic wipes • Cotton pad or gauze pad
• Gloves
• Adhesive bandage
• Sharps container • Surgical tape
Vial of Medication
(contains 16.6 mL)
Luer
Lock
Syringe
20 mm Vial
Adapter in
Sterile Blister
Luer Lock 25G
Subcutaneous
Administration Set

1.
Inspect carton and check the vial
Allow medication to come to room temperature
Take the box with the vial out of the refrigerator.
Check the box with the vial to make sure it has not passed its expiration date.
Do not use the medication if the expiration date has passed.
Let the box with the vial stand for about 30 minutes.
This will let the liquid come to a comfortable temperature for injection
(room temperature).
Keep out of direct sunlight.
Do not shake the box with the vial.
Check the liquid in the vial
Remove the vial from the box.
Do not shake the vial.
The liquid in the vial should be clear and colourless to light yellow.
Do not use if the liquid is discoloured or cloudy or contains any foreign particles and contact your healthcare provider for assistance.
2.
Prepare for the injection
Choose an injection site on the abdomen
DARZALEX is given by injection under the skin (subcutaneously).
Inject around the belly (abdomen) at least 7.5 cm away from the navel
(belly-button).
Use a different injection site for each injection.
Do not inject into skin that is tender, bruised, red, scaly, thick or hard. Avoid areas with scars or stretch marks.
Wash hands and put on gloves
Wash your hands very well with soap and warm water.
Put on gloves. Keep gloves on until dose has been administered and materials have been discarded.
* Areas in grey are recommended injection sites.

3.
Prepare vial and syringe
Remove cap
Lift the thin grey cap up to remove it from the top of the vial.
Do not remove the rubber stopper.
Clean rubber stopper
Clean the rubber stopper with an antiseptic wipe.
Put the vial on a flat surface.
Prepare vial adapter
Hold sterile blister as shown.
Peel back and remove paper backing.
Do not touch vial adapter at any time.
This may result in contamination.
Connect vial adapter to vial
Place vial on a flat surface and hold by the base.
Centre vial adapter over the grey rubber stopper.
Push vial adapter straight down onto vial top until it snaps securely into place.
Do not place vial adapter on at an angle or liquid may leak upon transfer to the syringe.

Remove sterile blister
Do not remove sterile blister from vial adapter until you are ready to attach the syringe to the vial adapter.
Keep vial vertical to prevent leakage.
Hold base of vial and pull up on the sterile blister to remove.
Do not touch the exposed opening on vial adapter.
This may result in contamination.
Fill the syringe with air
Pull the plunger down until the top line of the black rubber plunger is lined up with the 15 mL marker (see image).
Connect syringe to vial adapter
Firmly hold the bottom of the vial adapter.
Attach the syringe to the vial adapter by twisting the tip of the syringe clockwise onto the vial adapter.
Do not over-tighten.
Inject all of the air into the vial
Inject all of the air from the syringe into the vial, this will make the transfer of liquid from the vial to the syringe easier.

Transfer all liquid from vial to the syringe
Turn the vial and syringe upside-down.
Firmly grip the vial and syringe, then pull the syringe plunger to transfer all liquid into the syringe.
Due to the medication's thickness, you may feel resistance when transferring from vial to syringe.
Check to make sure the vial is empty.
Remove any air pockets or air bubbles
Hold the syringe pointing up.
Tap the side of the syringe until the air bubbles go to the top.
Push the plunger up until the air bubbles have been pushed out of the syringe back into the vial.
Check if air pockets or bubbles remain.
Repeat steps if necessary.
Remove syringe from vial adapter
When all of the liquid has been transferred to the syringe and air bubbles have been removed, gently twist the syringe off of the vial adapter. There may be a small amount of liquid in the vial, this is normal.
See Disposal steps on how to discard vial with the vial adapter in sharps container.
Attach syringe to subcutaneous administration set
Twist to attach the Luer Lock 25G subcutaneous administration set to the syringe.

Push syringe plunger to 15 mL
Do not remove needle protection cap.
Hold the needle over a sharps container or disposable cup to collect liquid from the needle.
Hold the syringe with the tip pointing up.
Slowly push the plunger until the top line of the black rubber plunger is lined up with the 15 mL marker to set a 15 mL dose.
Do not push the plunger past 15 mL because you will not receive the full dose.
You will see liquid come out of the needle. This is normal.
Dispose of the liquid per local regulations.
Place the syringe on a flat surface.
4.
Inject medication
Clean injection site on the abdomen
Wipe the chosen injection site with an antiseptic wipe and allow it to dry.
Do not touch, fan, or blow on the injection site after you have cleaned it.
Remove the needle protection cap
Remove the needle protection cap from the subcutaneous administration set needle by pulling it straight off.
Do not touch the needle or let the needle touch anything.
Pinch skin and insert needle
Gently pinch the cleaned skin at the injection site.
Push the needle into the pinched skin at around 45 degrees to the belly
(abdomen).
Release the fold of skin.
You may secure the needle to the injection site with surgical tape.

Inject 15 mL dose
Push the plunger steadily until the entire dose is delivered from the syringe. This should take approximately 3 to 5 minutes.
You may feel resistance when pushing the plunger. This is normal.
Continue to push the plunger slowly.
If you feel pain at the injection site, pause or slow down the injection. If the pain persists, stop the injection and contact your healthcare provider.
Confirm the dose is complete
After 3 to 5 minutes, check that the plunger is fully pressed down as far as it will go in the barrel of the syringe.
This means the dose is complete.
If the plunger is not fully to the end of the barrel of the syringe, continue to press until the dose is complete.
After delivering the full dose, carefully remove the subcutaneous administration set needle from the injection site.
Do not recap the needle.
After the injection
There may be a small amount of liquid at the injection site.
This is normal.
You can press a cotton ball or gauze gently over the injection site and hold for 10 seconds.
Do not rub the skin at the injection site. You may cover the injection site with a bandage, if necessary.
Disposal
Do not recap needle before disposing.
Used syringe, subcutaneous administration set and vial with vial adapter should be placed in a puncture-resistant container, like a sharps container.
Dispose of your sharps container according to your local regulations.
Antiseptic wipes and other supplies can be disposed of in your garbage.