Daratumumab is a monoclonal antibody that blocks a certain protein in the body that can affect tumor cell growth. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Daratumumab is used to treat multiple myeloma (bone marrow cancer).

Daratumumab is sometimes given after other cancer treatments did not work or have stopped working.

Daratumumab is sometimes used in combination with other cancer medicines plus a steroid medicine.

Daratumumab may also be used for purposes not listed in this medication guide.

If you need to receive a blood transfusion, be sure to tell your caregivers that you are being treated with daratumumab.

If you've ever had hepatitis B, using daratumumab can cause this virus to become active or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Carefully follow all instructions about the use of birth control while you are using daratumumab in combination with other medicines.

Daratumumab is given as an infusion into a vein. A healthcare provider will give you this injection.

Daratumumab is usually given every 1 to 3 weeks during the first several weeks of treatment. Then it is given once every 4 weeks until your body no longer responds to the medicine. Your doctor will determine how long to treat you with daratumumab.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

You will need frequent medical tests.

Daratumumab can affect blood tests that are used to match your blood type. If you need to receive a blood transfusion, be sure to tell your caregivers that you are being treated with daratumumab.

Daratumumab can affect blood-typing tests for up to 6 months after you stop using this medicine.

If you've ever had hepatitis B, using daratumumab can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

You should not be treated with daratumumab if you are allergic to it.

Tell your doctor if you have ever had:

• a hepatitis B;

• a breathing disorder; or

• herpes zoster (also called shingles).

Daratumumab may harm an unborn baby. Tell your doctor if you are pregnant or if you become pregnant. Use effective birth control to prevent pregnancy while you are using daratumumab and for at least 3 months after your last dose.

Daratumumab is sometimes used in combination with lenalidomide, pomalidomide, or thalidomide. Both men and women using these other drugs must use effective birth control. Even one dose can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking lenalidomide, pomalidomide, or thalidomide at the time of conception or during pregnancy.

Carefully follow all instructions about the use of birth control while you are using daratumumab in combination with other medicines.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Call your doctor for instructions if you miss an appointment for your daratumumab injection.

Since daratumumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, itchy, nauseated, or if you have a headache, stuffy nose, runny nose, cough, fever, chills, wheezing, trouble breathing, or a tight feeling in your throat.

Daratumumab may cause serious side effects. Call your doctor at once if you have:

• cough with yellow or green mucus;

• stabbing chest pain, wheezing, feeling short of breath;

• numbness, tingling, burning pain; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of daratumumab may include:

• nausea, constipation, diarrhea;

• fever;

• shortness of breath;

• nerve problems causing tingling, numbness, or pain;

• feeling tired or weak;

• swelling in your hands, ankles, or feet; or

• cold symptoms such as stuffy nose, sneezing, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect daratumumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.