What is this medication?

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.

COMMON BRAND NAME(S): DARZALEX

What should I tell my care team before I take this medication?

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

• hereditary fructose intolerance
• infection (especially a virus infection such as chickenpox, herpes, or hepatitis B virus)
• lung or breathing disease (asthma, COPD)
• an unusual or allergic reaction to daratumumab, sorbitol, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

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 medication?

Interactions have not been studied.

This list may not describe all possible interactions. 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 medication?

Your condition will be monitored carefully while you are receiving this medicine.

This medicine can cause serious allergic reactions. To reduce your risk, your health care provider may give you other medicine to take before receiving this one. Be sure to follow the directions from your health care provider.

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 health care provider 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 provider for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching or hives, swelling of the face, lips, or tongue
• Blurred vision
• Infection—fever, chills, cough, sore throat, pain or trouble passing urine
• Infusion reactions—dizziness, fast heartbeat, feeling faint or lightheaded, falls, headache, increase in blood pressure, nausea, vomiting, or wheezing or trouble breathing with loud or whistling sounds
• Unusual bleeding or bruising

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Diarrhea
• Pain, tingling, numbness in the hands or feet
• Swelling of the ankles, feet, hands
• 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 medication?

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.