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
  • 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.

What Are the Possible Side Effects of DARZALEX®?

How Is DARZALEX® Given?

Infusion Reactions

Infusion reactions are the most common side effect of treatment with DARZALEX® and can be severe. Almost half (48%) of patients in clinical trials had some type of infusion reactionInfusion reactions can occur with the first infusion (46%), the second infusion (5%), and subsequent infusions (4%). Tell your healthcare provider immediately if you get any of the symptoms listed below, which could be the sign of an infusion reaction.

If you get an infusion reaction, the infusion may be interrupted or stopped. When these symptoms go away, or improve, the infusion can be continued. These reactions are most likely to happen with the first infusion.

If you have had an infusion reaction once, it is less likely to happen with future infusions. Your healthcare provider may decide not to continue treatment with DARZALEX® if you have a strong infusion reaction.

Infusion reaction symptoms may include:
  • runny or stuffy nose
  • cough
  • chills
  • rash or hives
  • itching
  • throat tightness
  • shortness of breath or trouble breathing
  • wheezing
  • nausea
  • dizziness or lightheadedness (hypotension)
  • vomiting
  • headache

A healthcare professional will monitor you during the DARZALEX® infusion.


Changes in Blood Tests

DARZALEX® can affect the results of blood tests used 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.

The most common side effects of DARZALEX® include:
  • tiredness
  • nausea
  • back pain
  • fever
  • cough
  • cold-like symptoms (upper respiratory infection)

Tell your healthcare provider if you have any side effect that bothers your or that does not go away.