Darzalex® (daratumumab) is the first FDA-approved monoclonal antibody that targets the CD38 protein on the surface of myeloma cells. 

Who is a candidate for Darzalex?

In the US, Darzalex is FDA-approved for the treatment of adult patients with myeloma in the following settings: 

  • In newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT), in combination with Velcade® (bortezomib), thalidomide, and dexamethasone (VTd). 
  • In newly diagnosed patients who are ineligible for ASCT, in combination with Revlimid® (lenalidomide) and dexamethasone (Rd), or Velcade, melphalan, and prednisone (VMP). 
  • In patients who have received at least one prior therapy, in combination with Velcade and dexamethasone (Vd). 
  • In patients with relapsed or refractory myeloma who have received one to three previous lines of therapy, in combination with Kyprolis® (carfilzomib) and dexamethasone (Kd). 
  • In patients who have received at least two prior therapies including Revlimid + a proteasome inhibitor (Kyprolis, Ninlaro® [ixazomib], or Velcade), in combination with Pomalyst® (pomalidomide) and dexamethasone (Pd). 
  • As monotherapy in patients who have received at least three prior lines of therapy, including a proteasome inhibitor + an immunomodulatory drug (Pomalyst, Revlimid, or thalidomide), or who are double-refractory to a proteasome inhibitor and an immunomodulatory drug. 

How Is Darzalex given?

The original formulation of Darzalex is administered intravenously (IV) at the dose of 16 mg/kg of body weight. The first dose is usually given over a period of up to 8 hours. Especially with the first dose, the slower the rate of infusion, the less likely it is that a severe infusion reaction will occur. If the Darzalex infusion is well tolerated, subsequent doses may be given more rapidly at your doctor’s discretion. Your doctor may split the first IV infusion over two consecutive days. Medications are given before and after each infusion to help prevent a reaction

What are the possible side effects of Darzalex?

  • Side effects that occurred in ≥20% of the patients in the Darzalex registration clinical trials were infusion reactions, fatigue, nausea, back pain, fever, cough, and upper respiratory tract infection. Be sure to contact your doctor with your concerns. 
  • Darzalex may cause blood cell counts to drop, with patients experiencing anemia, thrombocytopenia, neutropenia, and lymphopenia. Your doctor will monitor your blood counts, and a reduction in the dose of Darzalex may be required. 
  • Darzalex can cause reactivation of the herpes zoster virus (shingles). All patients should receive preventive treatment with an antiviral medication. 
  • If you have ever had the hepatitis B virus (HBV), Darzalex can cause it to become active again. Your doctor will monitor you before, during, and for some time after treatment with Darzalex. 

Special precautions with Darzalex

  • Darzalex interferes with blood compatibility testing. Your doctor will type and screen your blood before you start treatment with Darzalex in case you need a blood transfusion subsequently. 
  • Females of reproductive potential should use effective contraception during treatment with Darzalex and for three months after stopping. 
  • Darzalex can be detected on both the SPEP and IFE assays used for the clinical monitoring of M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein. 

Janssen CarePath Program

Please call 1-844-553-2792 or visit for more information.

For information about the new formulation of Darzalex for subcutaneous (under the skin) administration, visit DARZALEX FASPRO™ .


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