Daratumumab injection is used alone or in combination with other medications to treat multiple myeloma (a type of cancer of the bone marrow) in newly diagnosed people and in people who have not improved with treatment or who have improved after treatment with other medications but the condition returned. Daratumumab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.

Daratumumab comes as a liquid (solution) that is given intravenously (into a vein) by a doctor or nurse in a healthcare setting. Your doctor will decide how often you are to receive daratumumab based on other medications that may be given and your body’s response to this medication.

A doctor or nurse will watch you closely while you are receiving the infusion and afterwards to be sure you are not having a serious reaction to the medication. You will be given other medications to help prevent and treat reactions to daratumumab prior to your infusion and for the first and second days after you receive your medication. Tell your doctor or nurse immediately if you experience any of the following symptoms: cough, wheezing, throat tightness and irritation, itchy, runny, or stuffy nose, headache, itching, nausea, vomiting, fever, chills, rash, hives, dizziness, lightheadedness, difficulty breathing, chest discomfort, or shortness of breath.

Your doctor may decrease your dose of daratumumab or temporarily or permanently stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with daratumumab.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving daratumumab injection,

• tell your doctor and pharmacist if you are allergic to daratumumab, any other medications, or any of the ingredients in daratumumab injection. Ask your pharmacist or check the manufacturer’s patient information for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are receiving blood transfusions or if you have or have ever had shingles (a painful rash that occurs after infection with herpes zoster or chickenpox), breathing problems, hepatitis B (a virus that infects the liver and may cause severe liver damage), or a lung disease such as chronic obstructive pulmonary disease (COPD; a group of lung diseases, which includes chronic bronchitis and emphysema).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use birth control to prevent pregnancy during your treatment with daratumumab and for at least 3 months after your final dose. Talk to your doctor about types of birth control that will work for you. If you become pregnant while receiving daratumumab injection, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving daratumumab injection.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive daratumumab, call your doctor right away.

Daratumumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• constipation
• diarrhea
• back or joint pain
• pain in your arms, legs, or chest
• decreased appetite
• headache
• swelling of the hands, ankles, or feet
• pain, burning, or tingling in the hands or feet
• muscle spasms
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment.

• bruising or bleeding
• fever
• extreme tiredness
• yellowing of the skin or eyes

Daratumumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body’s response to daratumumab injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving or received daratumumab injection. Daratumumab may affect the results of certain laboratory tests.

Daratumumab can affect blood matching test results for up to 6 months after your final dose. Before having a blood transfusion, tell your doctor and the laboratory personnel that you are receiving or received daratumumab injection. Your doctor will do blood tests to match your blood type before you start treatment with daratumumab.

Ask your pharmacist any questions you have about daratumumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Darzalex^®