Daratumumab, Injection

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KEY POINTS

• This medicine is given by IV to treat multiple myeloma.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); chemotherapy; monoclonal antibody

Generic and brand names: daratumumab, injection; Darzalex

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat multiple myeloma. It may be given to people who have already been treated with other types of chemotherapy and have not shown improvement.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Herpes zoster (shingles)
• Liver disease
• Lung disease or breathing problems

Females of childbearing age: This medicine is not given during pregnancy because it may harm the baby. Tell your healthcare provider if you are pregnant or plan to become pregnant. Use an effective method of birth control while receiving this medicine and for at least 3 months after you finish treatment. If you need advice about birth control, ask your healthcare provider. Do not breast-feed while receiving this treatment without your healthcare provider's approval.

How do I use it?

Other medicines may be given before this medicine and on the first and second day after each infusion to help prevent infusion reactions and reduce other side effects. You will be watched closely during and after your infusion. Carefully follow your healthcare provider’s instructions for taking any other medicines. If you feel pain or burning where the infusion is being given, tell your healthcare provider right away.

These infusions are given by your healthcare provider. This medicine is usually given weekly for the first 8 weeks, then every 2 weeks for 16 weeks, and then every 4 weeks after that. Keep all your appointments for infusions. How long you will need this treatment will be determined by your healthcare provider.

What if I miss a dose?

If you miss an appointment for an infusion, contact your healthcare provider right away to reschedule.

What should I watch out for?

This medicine may cause serious or life-threatening infusion reactions while you are receiving this medicine or up to 48 hours after receiving this medicine. Tell your healthcare provider right away if you have any symptoms of an infusion reaction, such as shortness of breath or trouble breathing, cough, wheezing, throat tightness, runny or stuffy nose, dizziness or lightheadedness, headache, nausea, vomiting, chills, itching, skin rash or hives.

This medicine may cause lightheadedness, dizziness, or drowsiness. Do not drive or operate machinery until you are fully alert.

This medicine may cause a flare up of shingles or cold sores. Contact your healthcare provider right away if you have these symptoms.

You need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine can affect the results of blood tests to match your blood type for up to 6 months after you stop treatment with this medicine. Tell all of your healthcare providers that you are being treated with medicine before receiving blood transfusions.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reactions (hives, itching, rash, tightness in your chest, swelling of your lips, tongue or throat, trouble breathing)

Serious (Report these to your healthcare provider right away.): Unexplained fever; shortness of breath, wheezing or coughing; severe dizziness or fainting; headache; severe nausea and vomiting; pale skin; unusual bruising or bleeding; unusual tiredness or weakness.

Other: Back pain; mild nausea; tiredness; stuffy or runny nose; diarrhea; constipation; decreased appetite.

What products might interact with this medicine?

No significant drug interactions have been reported, however do not have any vaccines without getting your healthcare provider's approval first.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.