DARZALEX (daratumumab)

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?

Darzalex® is a prescription medicine used to treat adults with multiple myeloma:

• In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people who have received at least one prior medicine to treat multiple myeloma.
• In combination with the medicines bortezomib, melphalan, and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
• In combination with the medicines bortezomib, thalidomide, and dexamethasone in newly diagnosed people who are eligible to receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
• In combination with the medicines bortezomib and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma 
• In combination with the medicines carfilzomib and dexamethasone in people who have received one to three prior medicines to treat multiple myeloma
• In combination with the medicines pomalidomide and dexamethasone in people who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor
• Alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent

How Is Darzalex Given?

The original formulation of Darzalex is administered intravenously (into the vein - IV) at the dose of 16 mg/kg of body weight. The first infusion may take about 7 hours. Your doctor may split the first IV infusion over two consecutive days. 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. 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 darzalex.com for more information.

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