Daratumumab Solution for injection

What is this medicine?

DARATUMUMAB (dar a toom ue mab) is a monoclonal antibody. It is used to treat multiple myeloma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• lung or breathing disease

• pregnant or trying to get pregnant

• breast-feeding

• an unusual or allergic reaction to daratumumab, other medicines, foods, dyes, or preservatives

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Interactions have not been studied.

Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

This medicine can cause serious allergic reactions. To reduce your risk you may need to take medicine before treatment with this medicine. Take your medicine as directed.

This medicine can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after the final dose. Your healthcare provider will do blood tests to match your blood type before you start treatment. Tell all of your healthcare providers that you are being treated with this medicine before receiving a blood transfusion.

This medicine can affect the results of some tests used to determine treatment response; extra tests may be needed to evaluate response.

Do not become pregnant while taking this medicine or for 3 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chills

• cough

• dizziness

• feeling faint or lightheaded

• headache

• nausea, vomiting

• shortness of breath

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• back pain

• fever

• joint pain

• loss of appetite

• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.