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 trials (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.
Janssen CarePath is your one source for access, affordability, and treatment support for your patients. Janssen CarePath helps verify insurance coverage for your patients, provides reimbursement information, helps find financial assistance options for eligible patients, and provides ongoing support to help patients start and stay on DARZALEX® as prescribed.
Call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728) Mon-Fri 8 am to 8 pm ET or visit JanssenCarePath.com
Getting started is easy at JanssenCarePathPortal.com
We understand that navigating payer processes and finding cost support options may seem complicated at times. That’s why we’ve created an enhanced Provider Portal experience. The Janssen CarePath Provider Portal gives you 24-hour online access to:
- Request benefits investigations
- Review the status of benefits investigations
- Enroll your eligible, commercially insured patients in the Janssen CarePath Savings Program
- View savings program transactions for enrolled patients
- Receive notifications when new information is available or action is required on the Portal
Create a Provider Portal account at JanssenCarePathPortal.com
- Complete required information, include your practice locations, add administrators and staff to your site, and set communication preferences
Complete the Business Associate Agreement (BAA) for your practice (one time only)
The completed BAA allows you to request verification of patients’ insurance benefits and enroll eligible patients in the Janssen CarePath Savings Program without requiring individual patient authorization
- You can execute the BAA within the Portal and receive immediate verification and access to the Portal, or
- You can download the BAA at JanssenCarePath.com and upload the signed document via the Portal or fax to the number provided
Secure patient authorization (for each patient)
Now you are ready to submit a benefits investigation on the Portal.
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.