FAQ

Frequently Asked Questions

Here are some common questions and answers regarding treatment with DARZALEX FASPRO® and DARZALEX®.

Indications

DARZALEX FASPRO® is indicated for the treatment of adult patients with newly diagnosed multiple myeloma:

  • Transplant eligible—in combination with VRd (induction and consolidation) and in combination with VTd1
  • Transplant ineligible—in combination with Rd and in combination with VMP1

DARZALEX® is indicated for the treatment of adult patients with newly diagnosed multiple myeloma:

  • Transplant eligible–in combination with VTd2
  • Transplant ineligible–in combination with Rd and in combination with VMP2

Rd=lenalidomide (R) + dexamethasone (d); VMP=bortezomib (V) + melphalan (M) + prednisone (P); VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d); VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).

Daratumumab* (D) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) is recommended by the NCCN Guidelines® as a Category 1 preferred therapeutic option for newly diagnosed, transplant-eligible multiple myeloma.3

Daratumumab* (D) in combination with lenalidomide and dexamethasone (Rd) is recommended by the NCCN Guidelines as a Category 1 preferred therapeutic option for newly diagnosed, transplant-deferred or not indicated multiple myeloma.3

Safety and effectiveness of DRd in the HCT-deferred population has not been evaluated in a phase 3 study and has not been established.

DRd=DARZALEX (D) + lenalidomide (R) + dexamethasone (d); HCT=hematopoietic cell transplant; NCCN=National Comprehensive Cancer Network.

*Daratumumab includes daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) for subcutaneous injection and daratumumab (DARZALEX®) for intravenous infusion. Daratumumab and hyaluronidase-fihj for subcutaneous injection has different dosing and administration instructions compared to daratumumab for intravenous infusion.

See NCCN.org for definitions of NCCN Categories of Preference and NCCN Categories of Evidence and Consensus.

Dosing and administration

DARZALEX FASPRO® is the only anti-CD38 monoclonal antibody that can be delivered subcutaneously in ~3 to 5 minutes.1

Safety and effectiveness of DRd in the HCT-deferred population was not studied and has not been established.

CD38=cluster of differentiation 38.

For adult patients who have newly diagnosed, transplant-ineligible multiple myeloma and are being treated with DRd, dosing frequency decreases to once every 4 weeks starting at Cycle 7.1,2

DRd=DARZALEX®/DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d).

In the COLUMBA trial, nearly 3× reduction in systemic ARRs with DARZALEX FASPRO® (13%, n=260) vs DARZALEX® (34%, n=258) was observed.4

Both systemic ARRs, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®.1

Coverage

DARZALEX FASPRO® and DARZALEX® are covered for ~97% of people with commercial insurance and ~97% of people with Medicare.7

This may not represent 100% of lives due to data limitations.

Mechanism of action

Daratumumab inhibits tumor cell growth through immune-mediated, direct on-tumor, and immunoregulatory actions. It may also have an effect on normal cells.1,2

Patient resources

There are a wide variety of resources available to help provide educational, emotional, and financial support to patients throughout their treatment.

Your patients have access to free 1-on-1 support from a dedicated Care Navigator* who can help them:

  • Understand their disease and learn more about DARZALEX® or DARZALEX FASPRO®
  • Find health and wellness resources for living with cancer
  • Explore cost support options regardless of their insurance type
  • Find online or in-person patient-to-patient support
  • Connect with transportation-related services in their community

Get started with J&J withMe

  • Visit Portal.JNJwithMe.com to investigate insurance coverage for your patients, enroll your patients in savings, or sign them up for Care Navigator support
  • Visit www.JNJwithMe.com/hcp/darzalex for access and affordability information for DARZALEX® and DARZALEX FASPRO®
  • Questions? Call 833-JNJ-wMe1 (833-565-9631), Monday through Friday, 8:00 AM to 8:00 PM ET

*Care Navigators do not provide medical advice.