Have an appropriate patient whom you would like to get started?
This page provides information that you should know prior to prescribing and administering DARZALEX®. Topics include infusion recommendations, administration considerations, and information on how to access DARZALEX® (Business Associate Agreement [BAA] and Benefit Investigation Form [BIF] documents, a list of specialty distributors, and a general overview of Janssen CarePath).
Important information before beginning treatment1
Infusion Reactions: 48% of patients experienced an infusion reaction.* For 46% of patients, infusion reactions (any grade) occurred with the first infusion; for 2% of patients, with the second infusion; and for 3% with subsequent infusions.†
- DARZALEX® can cause severe infusion reactions. Severe (Grade 3) infusion reactions included bronchospasm, dyspnea, laryngeal edema, pulmonary edema, hypoxia, and hypertension. Other adverse infusion reactions (any grade; ≥5%) were nasal congestion, cough, chills, throat irritation, and vomiting
- Pre- and post-infusion medications are recommended to reduce the risk of infusion reactions
- In clinical trials, median time to onset of an infusion reaction was 1.4 hours (range: 0.02 to 72.8 hours)
- Incidence of infusion modification due to reactions was 42%
*Infusion reaction information includes patients in DARZALEX® POLLUX, CASTOR, and monotherapy clinical trials (n=682).
†Infusion reaction information includes patients in DARZALEX® monotherapy and combination therapy clinical trails (n=820).
Interference with Serological Testing: DARZALEX® binds to CD38 on red blood cells and results in a positive Indirect Antiglobulin Test (Indirect Coombs test), which may persist for up to 6 months after the last DARZALEX® infusion. Be sure to type and screen patients prior to initiating treatment and to inform your blood bank that your patient is on DARZALEX®.
See the brochure about interference with serological testing.
Interference with Determination of Complete Response (CR): Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody (mAb) that can be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays, which can impact the determination of a CR and of disease progression in some patients with IgG kappa myeloma protein.
Neutropenia: Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. DARZALEX® dose delay may be required to allow recovery of neutrophils. No dose reduction of DARZALEX® is recommended. Consider supportive care with growth factors.
Thrombocytopenia: Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. DARZALEX® dose delay may be required to allow recovery of platelets. No dose reduction of DARZALEX® is recommended. Consider supportive care with transfusions.
Herpes Zoster Reactivation: Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week of starting DARZALEX® and continue for 3 months following treatment.
Median Infusion Duration: In clinical trials, median duration of the 1st infusion was 7.0 hours. Median durations for 2nd and subsequent infusions were 4.3 and 3.5 hours, respectively.
Treatment Delay and Discontinuation: 4% of patients in the monotherapy clinical trial discontinued treatment due to adverse reactions (ARs) and ARs resulted in treatment delays for 24 patients (15%); 7% of patients in the CASTOR and POLLUX trials discontinued treatment due to ARs.
A comprehensive support program to help patients start and stay on therapy. Janssen CarePath Care Coordinators can offer you and your patients access support and educational resources related to DARZALEX®.
Access Tools: Getting Started Is Easy
For more information or to complete the form over the phone, please call Janssen CarePath at 1-844-55DARZA (1-844-553-2792), Monday through Friday, 8:00 AM to 8:00 PM ET, and speak to a Janssen CarePath Care Coordinator.
After receiving your completed BIF, Janssen CarePath will research your patient’s health coverage and return a Verification of Benefits within 48 hours. Janssen CarePath will also attempt to call your patient to review benefits and discuss potential cost support options.
Ordering DARZALEX®: Specialty Distributors
The following specialty distributors are authorized to sell DARZALEX® and are able to service institutions and/or physician offices, and community practices.
Cardinal Health Specialty
CuraScript Specialty Distribution
McKesson Plasma & Biologics
McKesson Specialty Health
Janssen Biotech, Inc., does not endorse the use of any of the listed distributors in particular.