IMPORTANT SAFETY INFORMATION

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A new option for patients with multiple myeloma: DARZALEX® can now be used in combination with Revlimid® (lenalidomide) and dexamethasone or Velcade® (bortezomib) and dexamethasone in patients who have received at least one prior medicine.

How does DARZALEX® work?
  • DARZALEX® is not chemotherapy. DARZALEX® is a monoclonal antibody that works with your immune system. Monoclonal antibodies work by attaching themselves to multiple myeloma cells in your body and directly killing them, and/or signaling your immune system to destroy them
  • DARZALEX® finds and attaches to a protein called CD38, which is present on the surface of cells, including high numbers on myeloma cells
RESULTS SEEN IN CLINICAL TRIALS
  • The main goal of the study was to measure the length of time patients live without their multiple myeloma getting worse or their passing away from any cause
    • Another goal was to measure response rate, which is the percentage of patients who responded to treatment. Talk to your doctor about how response is measured
  • The majority of patients responded to the following DARZALEX® combination treatments:
    • ​DARZALEX® was studied in combination with Revlimid® and dexamethasone (Rd) vs Rd alone in 569 patients who had received a minimum of 1 prior treatment
      • 9 out of 10 patients responded to DARZALEX® + Rd vs 7 out of 10 with Rd alone
    • DARZALEX® was studied in combination with Velcade® and dexamethasone (Vd) vs Vd alone in 498 patients who had received a minimum of 1 prior treatment
      • Almost 8 out of 10 patients responded to DARZALEX® + Vd vs almost 6 out of 10 with Vd alone
  • DARZALEX® combination treatments reduced patients’ risk of their disease getting worse or their passing away from any cause by more than 60%

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Revlimid® is a registered trademark of Celgene Corporation.
Velcade® is a registered trademark of Millennium Pharmaceuticals, Inc.

Important Safety Information

What should I tell my healthcare provider before taking DARZALEX®?

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)
  • are pregnant or plan to become pregnant. DARZALEX® may harm your unborn baby.
    • Females who are able to become pregnant should use an effective method of birth control 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.
  • 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 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 on the first day after each dose of DARZALEX® to help reduce the risk of infusion reactions.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment

What are the possible side effects of DARZALEX®?

DARZALEX® may cause serious reactions, including:

  • Infusion reactions. Infusion reactions are common with DARZALEX® and can be severe. Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEX® if you have infusion reactions. Tell your healthcare provider 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. 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
  • fever
  • cough
  • muscle spasms
  • back pain
  • cold-like symptoms (upper respiratory infection)
  • nerve damage causing tingling, numbness or pain
  • swollen hands, ankles or feet

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.

Please see Important Product Information.

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What is DARZALEX®?
What is DARZALEX®?

DARZALEX® is a prescription medicine used to treat multiple myeloma:

  • In combination with the medicines lenalidomide and dexamethasone or bortezomib and dexamethasone, in people who have received at least one prior medicine to treat multiple myeloma.
  • Alone in people who have received at least three prior medicines to treat multiple myeloma, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent.

It is not known if DARZALEX® is safe and effective in children.