Important Safety Information for DARZALEX®

Do not receive DARZALEX® if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX®. See below for a complete list of ingredients.

Before you receive DARZALEX®, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of breathing problems
  • have had shingles (herpes zoster)
  • have ever had or might now have a hepatitis B infection as DARZALEX® could cause hepatitis B virus to become active again. Your healthcare provider will check you for signs of this infection before, during, and for some time after treatment with DARZALEX®. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes
  • are pregnant or plan to become pregnant. DARZALEX® may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with DARZALEX®
    • Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of DARZALEX®. Talk to your healthcare provider about birth control methods that you can use during this time
    • Before starting DARZALEX® in combination with lenalidomide, pomalidomide, or thalidomide, females and males must agree to the instructions in the lenalidomide, pomalidomide, or thalidomide REMS program
      • The lenalidomide, pomalidomide, and thalidomide REMS has more information about effective methods of birth control, pregnancy testing, and blood donation for females who can become pregnant
      • For males who have female partners who can become pregnant, there is information in the lenalidomide, pomalidomide, and thalidomide REMS about sperm donation and how lenalidomide, pomalidomide, and thalidomide can pass into human semen
  • are breastfeeding or plan to breastfeed. It is not known if DARZALEX® passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive DARZALEX®?

  • DARZALEX® may be given alone or together with other medicines used to treat multiple myeloma
  • DARZALEX® will be given to you by your healthcare provider by intravenous (IV) infusion into your vein
  • Your healthcare provider will decide the time between doses as well as how many treatments you will receive
  • Your healthcare provider will give you medicines before each dose of DARZALEX® and after each dose of DARZALEX® to help reduce the risk of infusion-related reactions
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment

DARZALEX® may cause serious reactions, including:

  • Infusion-related reactions. Infusion-related reactions are common with DARZALEX® and can be severe or serious. Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEX® if you have infusion-related reactions. Get medical help right away if you get any of the following symptoms: shortness of breath or trouble breathing, dizziness or lightheadedness (hypotension), cough, wheezing, throat tightness, runny or stuffy nose, headache, itching, nausea, vomiting, chills, fever
  • Changes in blood tests. DARZALEX® can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of DARZALEX®. Your healthcare provider will do blood tests to match your blood type before you start treatment with DARZALEX®. Tell all of your healthcare providers that you are being treated with DARZALEX® before receiving blood transfusions
  • Decreases in blood cell counts. DARZALEX® can decrease white blood cell counts, which help fight infections, and blood cells called platelets, which help to clot blood. Your healthcare provider will check your blood cell counts during treatment with DARZALEX®. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding

The most common side effects of DARZALEX® include: tiredness; nausea; diarrhea; shortness of breath; feeling weak; fever; cough; cold-like symptoms (upper respiratory infection); nerve damage causing tingling, numbness, or pain; swollen hands, ankles, or feet; constipation.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DARZALEX®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of DARZALEX®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about DARZALEX® that is written for health professionals.

Active ingredient: daratumumab.

Inactive ingredients: glacial acetic acid, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, and water for injection.

Please click here to see the Important Product Information.

cp-109238v4