Darzalex 800 mg Solution

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 1 800 mg solution for injection is used for

DARZALEX 1 800 mg solution for injection 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 1 800 mg solution for injection 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 1 800 mg solution for injection:

• have previously had a severe hypersensitivity (allergic) reaction to daratumumab or any of the other ingredients of DARZALEX (listed in section 6).
• are pregnant or breastfeeding (see Pregnancy and breastfeeding).
• have recently received a live attenuated vaccine (see Warnings and precautions).

Warnings and precautions

Tell your doctor or healthcare professional before being given the injection: Special care should be taken with DARZALEX 1 800 mg solution for injection: Infusion-related reactions. DARZALEX 1 800 mg solution for injection is given as a subcutaneous injection using a small needle to inject the medication under your skin. Before and after each infusion of DARZALEX 1 800 mg solution for injection, you will be given medicines which help to lower the chance of infusion-related reactions (see Medicines given during treatment with DARZALEX 1 800 mg solution for injection). These reactions are most likely to happen with the first injection and most reactions occur on the day of the 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 1 800 mg solution for injection if you have a strong reaction after the injection.

DARZALEX 1 800 mg solution for injection 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.

How much is given

Your doctor will work out your dose and schedule of DARZALEX 1 800 mg solution for injection. The dose of DARZALEX 1 800 mg solution for injection is 1 800 mg. DARZALEX 1 800 mg solution for injection may be given alone or together with other medicines used to treat multiple myeloma, or with other medicines used to treat AL amyloidosis. DARZALEX 1 800 mg solution for injection 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 1 800 mg solution for injection is given together with other medicines your doctor may change the time between doses as well as how many treatments you will receive.

DARZALEX 1 800 mg solution for injection can have side effects. Not all side effects reported for DARZALEX 1 800 mg solution for injection are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DARZALEX 1 800 mg solution for injection, 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:

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.

• chills
• sore throat, cough
• feeling sick (nausea)
• vomiting
• itchy, runny or blocked nose
• feeling short of breath or other breathing problems
• chest discomfort
• dizziness or lightheadedness (hypotension)
• itching
• wheezing
• eye pain
• blurred vision

These are all very serious side effects. If you have any of the above, you may need urgent medical attention or hospitalisation.

Allergic reactions

If any of the following happens, tell your doctor or nurse immediately or go to the casualty department at your nearest hospital:

• swollen face, lips, mouth, tongue or throat
• difficulty swallowing or breathing
• an itchy rash (hives)

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DARZALEX 1 800 mg solution for injection. You may need urgent medical attention or hospitalisation.

DARZALEX 1 800 mg solution for injection 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.