Medically reviewed by Bandela Mgoqi (B.Pharm, M.Pharm, MPS). Last updated on September 17, 2026.
DARZALEX is a cancer medicine that contains the active substance daratumumab. It belongs to a group of medicines called “monoclonal antibodies”. One of the ways monoclonal antibodies work is by attaching themselves to specific cancer cells in your body, so your immune system can destroy them.
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:
Tell your doctor or healthcare professional before being given the injection: Special care should be taken with DARZALEX:
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). 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 any itchy rash (hives). Some serious allergic reactions and other severe infusion-related reactions have resulted in death. Tell your doctor or nurse right away if you get any of the infusion-related reactions listed under POSSIBLE SIDE EFFECTS below. 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.
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.
DARZALEX can decrease white blood cell counts which help fight infections, and blood cells called platelets which help to clot blood. Tell your doctor or nurse if you develop fever or if you have signs of bruising or bleeding.
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.
It is not recommended to receive live viral or live bacterial vaccines with monoclonal antibody medicines.
Do not give DARZALEX to children or young people below 18 years of age. This is because it is not known how the medicine will affect them.
Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)
If you are pregnant or breastfeeding, think that you might be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before you are given this medicine.
Women who are pregnant or who may become pregnant must not receive DARZALEX. 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.
Women who are being given DARZALEX should use effective contraception during treatment and for 3 months after treatment.
Women who are receiving DARZALEX should not breastfeed their babies.
DARZALEX may make you feel tired. Do not drive because DARZALEX could interfere with your ability to drive safely. Do not operate any tools or machinery.
This medicine contains 9,3 mg sodium (main component of cooking/table salt) in each 5 mL vial. This is equivalent to 0,46 % of the recommended maximum daily dietary intake of sodium for an adult. This medicine contains 37,3 mg sodium (main component of cooking/table salt) in each 20 mL vial. This is equivalent to 1,86 % of the recommended maximum daily dietary intake of sodium for an adult.
If you have been told that you have an intolerance to some sugars, you should not receive DARZALEX.
Do not share medicines prescribed for you with any other person. You will not be expected to give yourself DARZALEX, it will be given to you by a doctor or nurse. It is given as a drip into a vein (“intravenous infusion”) over several hours. 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:
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.
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:
After each infusion of DARZALEX you will be given medicines (such as corticosteroids) to lower the chance of infusion-related reactions.
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:
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.
If you stop treatment with DARZALEX
You should not stop receiving DARZALEX without discussing with your doctor first.
DARZALEX can have side effects. Not all side effects reported for DARZALEX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DARZALEX, please consult your doctor, pharmacist or other health care professional for advice.
If any of the following happens, tell your doctor or nurse straight away or go to the casualty department at your nearest hospital:
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 are frequent.
These are all very serious side effects. If you have any of the above, you may need urgent medical attention or hospitalisation.
If any of the following happens, tell your doctor or nurse immediately or go to the casualty department at your nearest hospital:
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DARZALEX. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice any of the following:
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist as soon as possible.
- DARZALEX will be stored at the hospital or clinic.
- Store all medicines out of reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and 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.
- Medicines should not be disposed of via wastewater or household waste (i.e. drains or sewerage systems (e.g. toilets). Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.
The Darzalex 20 mg Solution professional information leaflet below is the property of Janssen Pharmaceutica (Pty) Ltd and is provided on Somayeza exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Somayeza serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
The patient information text is available above. Load the original PDF only when you need it.