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Resources to support your practice
Advancing frontline knowledge: KOL expert series on patients with newly diagnosed, transplant-ineligible 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.
Focus: MM patient
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.
Focus: frail MM patient
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.
Focus: high-risk MM patient
Rd=lenalidomide (R) + dexamethasone (d).
Dosing and administration guides
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®.
DARZALEX FASPRO® administration video
Resources to help support your patients with multiple myeloma
A free, personalized support program that can help your patients get started with their treatment and stay on track. Look to Janssen Compass™ to help guide them in navigating educational resources they need to feel confident on their Janssen therapy, as well as understanding their insurance coverage, out-of-pocket cost saving options, and affordability support.
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.
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.
Helps patients better understand treatment with DARZALEX FASPRO®.
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
Multiple myeloma cells can go unrecognized by the body, which allows them to grow.
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.
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.
What daratumumab-based regimens are approved for newly diagnosed, transplant-ineligible patients with multiple myeloma?
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).
What are the NCCN Guidelines recommendations for treating patients with newly diagnosed, transplant-ineligible multiple myeloma with DRd?
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 V3.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed December 12, 2022. To view the most recent and complete version of the guideline, go online to www.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
When do patients with newly diagnosed, transplant-ineligible multiple myeloma transition to once-monthly dosing with DARZALEX FASPRO® or DARZALEX® + Rd?
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).
Is DARZALEX FASPRO® associated with reduced administration-related reactions (ARRs) compared with DARZALEX®?
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
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.2,9
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).2,10
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.2,11
DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); ECOG=Eastern Cooperative Oncology Group; ISS=International Staging System.
Why is it important to discuss with newly diagnosed, transplant-ineligible patients the need for continuous DRd treatment until progression or unacceptable toxicity?
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.
DARZALEX FASPRO® and DARZALEX® are covered for ~97% of people with commercial insurance and ~97% of people with Medicare.12
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
What support resources are available for patients to help along their treatment journey with DARZALEX FASPRO® or DARZALEX®?
There are a wide variety of resources available to help provide educational, emotional, and financial support to patients throughout their treatment.
Janssen Compass™ is a free, personalized support program that can help your patients get started with their treatment and stay on track. Look to Janssen Compass™ to help guide them in navigating educational resources they need to feel confident on their Janssen therapy, as well as understanding their insurance coverage, out-of-pocket cost saving options, and affordability support.