DARZALEX 20 mg/mL concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

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.

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.

• 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.

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 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.

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.

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.

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.

Women who are being given DARZALEX should use effective contraception during treatment and for 3 months after treatment.

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.

You may feel tired after taking DARZALEX which may affect your ability to drive or use machines.

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.

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.

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.

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.

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.

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).

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.

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.

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 1,000 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.

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
• 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).

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

• 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).

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.

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