1800 mg injection solution 
daratumumab

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What DARZALEX is and what it is used for 
2. What you need to know before you receive DARZALEX 
3. How DARZALEX is given 
4. Possible side effects 
5. How to store DARZALEX 
6. Contents of the packaging and other information 

1. What DARZALEX is and what it is used for

What DARZALEX is

DARZALEX is a cancer medicine that contains the active substance daratumumab. It belongs to a group of drugs called monoclonal antibodies. Monoclonal antibodies are proteins that have been designed to recognize and attach to specific targets in the body. Daratumumab is designed to attach to specific cancer cells in your body so that the immune system can destroy the cancer cells.

What DARZALEX is used for

DARZALEX is used in adults who are 18 years of age or older and who have a type of cancer called multiple myeloma. It is a bone marrow cancer.

2. What you need to know before you get DARZALEX

You must not be treated with 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 have any further questions, ask your doctor or nurse before taking DARZALEX.

Warnings and cautions

Talk to your doctor or nurse before receiving DARZALEX.

Infusion-related reactions

DARZALEX is given as a subcutaneous injection with a thin needle to inject the medicine under the skin. Before and after each injection, you will be given medicines to help reduce the risk of infusion-related reactions (see “Medicines given during treatment with DARZALEX” in section 3). These reactions are most likely to occur during the first injection and most reactions occur on the same day. If you have had an infusion-related reaction once, it is less likely to happen again. However, delayed reactions may occur 3-4 days after injection. Your doctor may decide not to use DARZALEX if you get a severe reaction after the injection.

In some cases, you may have a severe allergic reaction that 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 immediately if you get any of the infusion-related reactions listed at the top of section 4. If you get infusion-related reactions you may need to get other medicines to treat your symptoms or your injection may need to be stopped. When these reactions disappear or are alleviated, the injection can be restarted.

Decreased number of blood s

DARZALEX can reduce the number of white blood cells that help the body fight infections, and blood cells called platelets that cause the blood to clot. Tell your doctor or nurse if you experience symptoms of infection such as fever, or symptoms of decreased platelet count such as bruising or bleeding.

Blood transfusion is

If you need a blood transfusion, you will first have a blood test to check your blood type. DARZALEX may affect the results of that blood test. Tell the person taking the test that you are being treated with DARZALEX.

Hepatitis B

Tell your doctor if you have ever had or may have a hepatitis B infection. The reason for this is that DARZALEX may lead to the reactivation of the hepatitis B virus. Your doctor will check you for signs of this infection before, during, and for some time after treatment with DARZALEX. Tell your doctor immediately if you experience worsening fatigue or yellowing of the skin or whites of the eyes.

Children and young people

Do not give DARZALEX to children or adolescents under 18 years of age. The reason for this is that it is not known how the drug 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 also applies to over-the-counter medicines and herbal medicines.

Pregnancy, breastfeeding, and fertility

Pregnancy

Talk to your doctor or nurse before receiving DARZALEX if you are pregnant, think you may be pregnant, or are planning to have a baby.

If you become pregnant during treatment with this medicine, tell your doctor or nurse immediately. You and your doctor will decide if the benefit of the medicine outweighs the risk to your child.

Contraceptive

Women treated with DARZALEX should use effective contraception during treatment and for 3 months after treatment.

Breast-feeding

You and your doctor will decide if the benefits of breastfeeding outweigh the risks to your baby. The reason for this is that the drug can pass into breast milk and it is not known how the drug can 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 injection for subcutaneous injection contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per 15 ml, ie essentially ‘sodium-free’.

DARZALEX injection, solution for subcutaneous injection contains sorbitol

Sorbitol is a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that prevents you from breaking down fructose, talk to your doctor before taking this medicine.

How DARZALEX is given

How much DARZALEX should you get?

Dose one of the DARZALEX solutions for injection for subcutaneous injection is 1800 mg.

DARZALEX can be given alone or in combination with other medicines used to treat multiple myeloma. When given alone, DARZALEX should be given as follows:

  • once a week for the first 8 weeks
  • then once every two weeks for 16 weeks
  • then once every 4 weeks as long as your condition does not worsen.

When DARZALEX is given with other medicines, your doctor may change the time between doses and how many treatments you should receive.

How the medicine is given

You will receive DARZALEX by a doctor or nurse as an injection under the skin ( subcutaneous injection ) for about 3 to 5 minutes. It is given in the stomach (abdomen) but not elsewhere on the body. It is also not given in places in the abdomen where the skin is red, bluish, sore, hard, or where there are scars.

If you experience pain during injection one, your doctor or nurse may discontinue injection one and give you the remaining injection one in another area of ​​your abdomen.

Medicines are given during treatment with DARZALEX

You can get medicines that reduce the risk of getting shingles.

Before each injection of DARZALEX, you will be given medicines that will help reduce the risk of infusion-related reactions. It could be:

  • medicines for allergic reactions ( antihistamines )
  • anti- inflammatory drugs ( corticosteroids )
  • medicines for fever (eg paracetamol ).

After each injection of DARZALEX, you will be given medicines (eg corticosteroids ) to reduce the risk of infusion-related reactions.

People with breathing problems

If you have breathing problems, e.g. asthma or chronic obstructive pulmonary disease (COPD), you will be given inhaled medicines to help with your breathing problems:

  • drugs that help the airways in the lungs to stay open ( bronchodilators )
  • drugs that reduce swelling and irritation in the lungs ( corticosteroids )

If you take more DARZALEX then you should

This medicine will be given by a doctor or nurse. If you are unlikely to get too much (an overdose), your doctor will check to see if you get any side effects.

If you miss a treatment with DARZALEX

You must come to all booked treatment sessions for your treatment to work. If you forget a treatment opportunity, book a new one as soon as possible.

If you have any further questions on the use of this product, ask 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 get any of the following symptoms within 3-4 days after injection. You may need other medicines, or the treatment may need to be adjusted.

These reactions include the following symptoms:

Very common (may affect more than 1 user in 10):

  • overindulge
  • sore throat, cough
  • nausea
  • vomiting
  • itchy, runny, or stuffy nose
  • shortness of breath or other breathing problems.

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

  • chest discomfort
  • dizziness or fainting (drop in blood pressure)
  • itching
  • hissing breathing.

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

  • The severe allergic reaction may include a swollen face, lips, mouth, tongue, or throat, difficulty swallowing or breathing, or an itchy rash (hives). See section 2.

If you get any of the above infusion-related reactions, tell your doctor or nurse immediately.

Injection site reactions

Skin reactions at or near the site (locally), including injection site reactions can occur with DARZALEX injection, solution for subcutaneous injection. These reactions are common (may affect up to 1 in 10 people) and may include symptoms:

  • reddening of the skin
  • itching
  • swelling.

Other side effects are

Very common (may affect more than 1 user in 10):

  • fever
  • severe fatigue
  • diarrhea
  • constipation
  • decreased appetite
  • difficulty sleeping
  • headache
  • nerve damage that can cause tingling, numbness, or pain
  • muscle spasms
  • joint pain
  • high blood pressure
  • swollen hands, ankles, or feet
  • feeling weak
  • back pain
  • lung infection ( pneumonia )
  • tracheal catarrh
  • infection in the respiratory tract – e.g. in the nose, sinuses, or throat
  • the low number of red blood cells that carry oxygen in the blood ( anemia, anemia )
  • low white blood cell count to help fight infection ( neutropenia, lymphopenia, leukopenia )
  • a low number of a type of blood cell called platelets that helps the blood to coagulate ( thrombocytopenia ).

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

  • irregular heartbeat ( atrial fibrillation )
  • fluid accumulation in the lungs leading to shortness of breath
  • urinary tract infection
  • severe infection affecting the whole body ( sepsis )
  • dehydration
  • high blood sugar level
  • low calcium levels in the blood
  • dizziness
  • chest muscle pain
  • influenza
  • overindulge
  • rash
  • itching
  • abnormal sensation in the skin (a stinging or creeping sensation)
  • pancreatitis
  • a type of herpesvirus infection (cytomegalovirus infection).

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

  • liver inflammation ( hepatitis ).

5. How to store DARZALEX

DARZALEX injection, solution for subcutaneous injection 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 vial after “EXP”. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

Store in the original package. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Healthcare professionals will discard all medicines that are no longer used. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is daratumumab. 1 ml solution contains 120 mg daratumumab. 1 vial with 15 ml solution for injection contains 1800 mg daratumumab.
  • The other ingredients are recombinant human hyaluronidase (rHuPH20), L ‑ histidine, L ‑ histidine hydrochloride monohydrate, L ‑ methionine, polysorbate 20, sorbitol (E420), and water for injections (see DARZALEX contains sodium and sorbitol in section 2).

What the medicine looks like and the contents of the pack

DARZALEX injection, the solution for subcutaneous injection is a colorless to yellow liquid.

DARZALEX injection, solution for subcutaneous injection in a carton containing 1 vial of a single dose.

Marketing Authorisation Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Biologics BV

Einsteinweg 101

NL-2333 CB Leiden

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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