Daratumumab (dar-a-TOOM-ue-mab)

Treats multiple myeloma.

Brand Name(s):

Darzalex

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• You may be given other medicines (including allergy medicine, antiviral medicine, fever medicine, or steroid) before and after receiving this infusion.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use effective birth control during treatment and for at least 3 months after the last dose.
• Tell your doctor if you are breastfeeding, or if you have liver disease (including hepatitis B infection), hereditary fructose intolerance, or a history of shingles (herpes zoster infection) or lung or breathing problems.
• This medicine may cause the following problems:
  • Infusion reaction, which can be life-threatening
  • Eye or vision problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results. Tell your doctor that you are receiving this medicine before you receive a blood transfusion.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, chest pain, trouble breathing, fast, slow, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Rapid weight gain, swelling of your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Back pain, muscle spasms
• Constipation, diarrhea, nausea, vomiting, loss of appetite
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Tiredness
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088