MULTIPLE MYELOMA RESOURCES

Resources to support your practice

Dosing and administration guide

Step-by-step instructions on how to administer DARZALEX FASPRO® and DARZALEX®.

Patient identification card

ID card informing healthcare providers about treatment with DARZALEX FASPRO® or DARZALEX®.

Daratumumab and serologic testing brochure

Overview of what to know regarding serological testing interference and daratumumab.

Specialty Distributor list

List of Specialty Distributors and their contact information for ordering DARZALEX FASPRO® and DARZALEX®.

DARZALEX FASPRO® administration video

Advancing frontline knowledge

KOL expert series on treating patients with newly diagnosed, transplant-ineligible multiple myeloma

Continuous frontline treatment with DARZALEX® + Rd and patient outcomes

Dr. Suzanne Reim Fanning, Associate Professor at USC School of Medicine Greenville, discusses what the research says about the importance of continuing frontline treatment with DARZALEX® until disease progression or unacceptable toxicity, and how doing so shapes outcomes for patients with multiple myeloma.

Patient considerations when determining frontline treatment

Dr. Kenneth Shain, Director of the Myeloma Working Group at Moffitt Cancer Center (Tampa, Florida), discusses a typical patient seen in his practice and how he reviews safety and efficacy data along with NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) when choosing a frontline treatment option.

MAIA study on frontline treatment with DARZALEX® + Rd vs Rd alone, including primary results, and post hoc analysis in frail patients

Dr. Ruemu Birhiray, the founder of Indy Hematology Review, explores safety and efficacy data of the MAIA trial, including a post hoc analysis in frail patients.

MAIA study of patients on frontline triplet DARZALEX® + Rd vs Rd alone, along with high-risk subgroup analysis

Dr. Kenneth Shain reviews the efficacy and safety of DRd vs Rd from the MAIA trial, including a subgroup analysis in patients with a high-risk cytogenetic profile.

Rd=lenalidomide (R) + dexamethasone (d).

Once you have made the clinical decision to prescribe DARZALEX® or DARZALEX FASPRO®, Johnson & Johnson has resources to help you support your patients.

Access and affordability resources plus personalized support for your patients
  • Access support to help navigate payer processes
  • Affordability resources to help patients discover ways to afford their DARZALEX®
    or DARZALEX FASPRO®
  • Dedicated 1-on-1 support for patients to support the nonclinical needs that may arise
    while on DARZALEX® or DARZALEX FASPRO®
Get connected to access and affordability resources

For more information, visit JanssenCarePath.com or call 877-227-3728, Monday through Friday, 8:00 AM to 8:00 PM ET

Get your patients connected to dedicated 1-on-1 support

You or your patient can call 844-628-1234, Monday through Friday, 8:30 AM to 8:30 PM ET

The patient support and resources provided by Johnson & Johnson are not intended to provide medical advice, replace a treatment plan from the patient’s doctor or nurse, provide case management services, or serve as a reason to prescribe DARZALEX® or DARZALEX FASPRO®.

Helpful tools you can share with your patients and their caregivers

Conversation starter guide

A tally of questions related to DARZALEX FASPRO® treatment that patients can choose from to discuss with their healthcare team.

Customized conversation starter

Interactive tool that allows patients to create a list of questions for discussion with their healthcare team on topics relevant to their condition and DARZALEX FASPRO® treatment.

Dosing calendar

Helps your patients stay on track with their DARZALEX FASPRO® treatment regimen.

Customized dosing calendar

Interactive tool patients can use to generate dosing calendars for their DARZALEX FASPRO® regimen.

Patient brochure

Helps patients better understand treatment with DARZALEX FASPRO®.

Patient website

Comprehensive resource dedicated to educating and supporting patients with multiple myeloma and their caregivers.

Education and support groups

A list of organizations that provide education and support to patients with multiple myeloma.

Understanding the science behind DARZALEX FASPRO® and DARZALEX®
How daratumumab works1,2
Daratumumab is a CD38-targeted monoclonal antibody, which is an immunotherapy that works with the immune system.1,2
DARZALEX® (daratumumab) & DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) mechanism of action (MOA)
Multiple myeloma cells can go unrecognized by the body, which allows them to grow.
N/A
Daratumumab attaches itself to the CD38 protein on the surface of multiple myeloma cells, as well as on certain other types of cells, such as red blood cells.
 DARZALEX® (daratumumab) & DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) mechanism of action (MOA)
Daratumumab directly kills multiple myeloma cells and/or allows the immune system to identify and destroy them. Because of the way daratumumab works, it may also affect normal cells.
Daratumumab MOA video
How DARZALEX FASPRO® allows for ~3 to 5 minute administration
DARZALEX FASPRO® is the first and only CD38-targeted monoclonal antibody in a subcutaneous formulation.1,3-8
DARZALEX FASPRO® contains recombinant hyaluronidase, which mimics hyaluronidase, a naturally occurring substance that increases permeability of subcutaneous tissue. This makes it possible for 15 mL containing 1,800 mg of daratumumab to be administered in approximately 3 to 5 minutes.1
Recombinant hyaluronidase works locally and transiently to degrade hyaluronan ([HA], a naturally occurring glycosaminoglycan found throughout the body) in the extracellular matrix of the subcutaneous space. It cleaves the linkage between the 2 sugars (N-acetylglucosamine and glucuronic acid) that comprise HA. Recombinant hyaluronidase has a half-life of 0.5 days.1
The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.1
DARZALEX FASPRO® can cause serious adverse reactions, including systemic administration-related reactions (ARRs). DARZALEX FASPRO® may increase neutropenia and thrombocytopenia induced by background therapy, therefore monitor complete blood cell counts periodically during treatment.1
Daratumumab and hyaluronidase MOA video

Get in touch

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Questions & answers

Here are some common questions and answers regarding treatment with DARZALEX FASPRO® and DARZALEX® for newly diagnosed, transplant-ineligible multiple myeloma.
Indications

DARZALEX FASPRO® and DARZALEX® are indicated for the treatment of adult patients with newly diagnosed, transplant-ineligible multiple myeloma in combination with Rd and in combination with VMP.1,2

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

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-ineligible multiple myeloma.

*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.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.2.2024. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed November 2, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Dosing and administration

DARZALEX FASPRO® is a ~3 to 5 minute injection administered subcutaneously starting with the first dose.1

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 3x reduction in systemic ARRs with DARZALEX FASPRO® (13%, n=260) vs DARZALEX® (34%, n=258) was observed.1

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

Efficacy

The efficacy of DRd was evaluated in the MAIA trial, a phase 3, global, randomized, open-label trial, comparing treatment with DRd (n=368) to Rd (n=369) in adult patients with newly diagnosed, transplant-ineligible multiple myeloma. In the trial, treatment was continued until disease progression or unacceptable toxicity.2,3

The primary efficacy endpoint was progression-free survival (PFS). One of the secondary endpoints was overall survival (OS).2

After 28 months of follow-up, there was a 44% reduction in the risk of disease progression or death with DRd vs Rd alone (HR=0.56; 95% CI: 0.43, 0.73; P<0.0001).2

After 64 months of follow-up, median PFS was 61.9 months (95% CI: 54.8-NE) with DRd vs 34.4 months (95% CI: 29.6-39.2) with Rd (HR=0.55; 95% CI: 0.45, 0.67).

CI=confidence interval; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; NE=not estimable; Rd=lenalidomide (R) + dexamethasone (d).

In the MAIA trial, DRd was evaluated in a wide range of patients. About 50% of patients were 75 years of age or older and the trial included patients with various ECOG performance status, cytogenetic profiles, and ISS disease stages.2,4

DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); ECOG=Eastern Cooperative Oncology Group; ISS=International Staging System.

DRd is indicated for the treatment of newly diagnosed, transplant-ineligible multiple myeloma until progression or unacceptable toxicity. For the best chance of achieving the PFS and sustained responses seen in the MAIA trial, patients should be treated with DRd until progression or unacceptable toxicity.2

DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); PFS=progression-free survival.

Coverage

DARZALEX FASPRO® and DARZALEX® are covered for ~97% of people with commercial insurance and ~97% of people with Medicare.5

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

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
  • Help them find online or in-person patient-to-patient support
  • Connect them with transportation-related services in their community

To get your patient connected to a Care Navigator, you or your patient can call 844-628-1234, Monday through Friday, 8:30 AM to 8:30 PM ET. 

*Care Navigators do not provide medical advice.