Introducing DARZALEX FASPRO (daratumumab and hyaluronidase-fihj): 
subcutaneous administration in ~3 to 5 minutes
1

SAME POWERFUL EFFICACY. 
FASTER ADMINISTRATION.1,2

Approved across 5 indications spanning a wide range 
of multiple myeloma patients1

Five indications to treat a wide range of multiple myeloma patients1

DRd=DARZALEX FASPRO (D) + lenalidomide (R) + dexamethasone (d); DVd=DARZALEX FASPRO (D) + bortezomib (V) + dexamethasone (d); DVMP=DARZALEX FASPRO (D) + bortezomib (V) + melphalan (M) + prednisone (P); PI=proteasome inhibitor.

COLUMBA STUDY: subcutaneous DARZALEX FASPRO (daratumumab + hyaluronidase-fihj) vs
intravenous DARZALEX® (daratumumab)

COLUMBA is a phase 3, randomized, open-label, non-inferiority, multicenter trial comparing DARZALEX FASPRO monotherapy vs DARZALEX® monotherapy in 522 adult patients with relapsed or refractory multiple myeloma1

ECOG=Eastern Cooperative Oncology Group; PD=progressive disease; QW=once weekly; Q2W=every 2 weeks; Q4W=every 4 weeks.

*Including a proteasome inhibitor (PI) and an immunomodulatory agent, or double refractory to a PI and an immunomodulatory agent.

Patient characteristics

  • Baseline demographics and disease characteristics were similar between the 2 treatment groups1
    • The median age was 67 years (range: 33–92). The median weight was 73 kg (range: 29–138). Patients had received a median of 4 prior lines of therapy; 51% had a prior ASCT and 100% had received both a PI and an immunomodulatory agent

Non-inferiority co-primary endpoints

  • Overall response rate (ORR) and a maximum trough (Ctrough) concentration of daratumumab measured on Day 1 of Cycle 31

Selected secondary endpoints

  • Percentage of patients with systemic ARRs, very good partial response (VGPR) or better rate, complete response (CR) or better rate, and progression-free survival (PFS)3

ASCT=autologous stem cell transplant.

According to International Myeloma Working Group (IMWG) response criteria.

Efficacy consistent with DARZALEX®

Co-primary endpoint achieved in the COLUMBA trial:
non-inferior to DARZALEX® with regard to ORR1

*DARZALEX FASPRO (95% CI: 35%, 47%).

DARZALEX® (95% CI: 31%, 43%).

  • The co-primary endpoint of remaining therapeutic drug concentration (maximum Ctrough) of DARZALEX FASPRO was also non-inferior to DARZALEX®1

CR=complete response; Ctrough=trough concentration; ORR=overall response rate; PR=partial response; VGPR=very good partial response.

Fewer systemic administration-related reactions (ARRs)

Nearly 3x reduction in systemic ARRs with DARZALEX FASPRO
vs DARZALEX® (daratumumab) observed in the COLUMBA trial1

Both systemic ARRs, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO.1

In a pooled safety population of 490 patients, the rate of systemic ARRs was 11% for DARZALEX FASPRO1

  • The median time to onset of systemic ARRs following an injection of DARZALEX FASPRO was 3.7 hours (range: 9 minutes to 3.5 days). The majority of systemic ARRs occurred on the day of treatment. Delayed systemic ARRs, those occurring after the day of administration, have occurred in less than 1% of patients
  • The incidence of any grade systemic ARRs was 10% with the first injection of DARZALEX FASPRO at Week 1, 0.2% with the second injection at Week 2, and cumulatively 0.8% with subsequent injections

Local reactions1

  • In this pooled safety population, injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 0.6%. The most frequent (>1%) injection-site reaction was injection site erythema
  • These local reactions occurred a median of 7 minutes (range: 0 minutes to 4.7 days) after starting administration of DARZALEX FASPRO. Monitor for local reactions and consider symptomatic management

*Systemic ARRs causing severe reactions included hypoxia, dyspnea, hypertension, and tachycardia. Other signs and symptoms of systemic ARRs may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, and hypotension.1

Safety generally consistent with DARZALEX®

Adverse reactions reported in ≥10% of patients receiving either DARZALEX FASPRO or DARZALEX®1

aUpper respiratory tract infection includes acute sinusitis, nasopharyngitis, pharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, rhinovirus infection, sinusitis, and upper respiratory tract infection.

bPneumonia includes lower respiratory tract infection, lung infection, pneumocystis jirovecii pneumonia, and pneumonia.

cFatigue includes asthenia and fatigue.

dSystemic ARRs includes terms determined by investigators to be related to infusion. In clinical trials of DARZALEX FASPRO, DARZALEX®, and the Prescribing Information for DARZALEX®, the term "infusion reactions" was used instead of "systemic ARRs".

eCough includes cough and productive cough.

fDyspnea includes dyspnea and dyspnea exertional.

gOnly Grade 3 adverse reactions occurred.

hGrade 5 adverse reactions occurred.

  • Serious adverse reactions occurred in 26% of patients who received DARZALEX FASPRO vs 29% of patients who received DARZALEX®. Fatal adverse reactions occurred in 5% of patients receiving DARZALEX FASPRO. Fatal adverse reactions occurring in more than 1 patient were general physical health deterioration, septic shock, and respiratory failure. Fatal adverse reactions occurred in 7% of patients receiving DARZALEX®1,3

Select laboratory abnormalities worsening from baseline in patients receiving either DARZALEX FASPRO or DARZALEX®1

aDenominator is based on the safety population treated with DARZALEX FASPRO (n=260) or with DARZALEX® (n=258).

Supporting evidence for combination therapy

DARZALEX FASPRO demonstrated response in multiple regimens1

PLEIADES is a phase 2, multicohort, open-label trial* evaluating the efficacy and safety of DARZALEX FASPRO (n=132)

  • Primary endpoint in the DVMP and DRd arms: ORR

Results in patients who are newly diagnosed

  • 88% ORR and 64% VGPR or better when used in combination with bortezomib, melphalan, and prednisone (DVMP) in patients with newly diagnosed multiple myeloma who are ineligible for transplant (n=67)1†

Results after 1 or more prior multiple myeloma therapies

  • 91% ORR and 65% VGPR or better when used in combination with lenalidomide and dexamethasone (DRd) in patients with relapsed or refractory multiple myeloma (n=65)1†

*PLEIADES is a phase 2, multicohort, open-label trial of DARZALEX FASPRO in combination with DVMP in patients with newly diagnosed multiple myeloma who are ineligible for transplant, in combination with DRd in patients with relapsed or refractory multiple myeloma.

Based on treated subjects.

Safety profile in DARZALEX FASPRO + VMP

Adverse reactions (≥10%) in patients receiving DARZALEX FASPRO in combination with bortezomib, melphalan, and prednisone (DVMP)1

aUpper respiratory tract infection includes nasopharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, tonsillitis, upper respiratory tract infection, and viral pharyngitis.

bPneumonia includes lower respiratory tract infection, lung infection, pneumocystis jirovecii pneumonia, pneumonia, and pneumonia bacterial.

cAbdominal pain includes abdominal pain and abdominal pain upper.

dFatigue includes asthenia and fatigue.

eEdema peripheral includes edema, edema peripheral, and peripheral swelling.

fCough includes cough and productive cough.

gOnly Grade 3 adverse reactions occurred.

Safety profile in DARZALEX FASPRO + Rd

Adverse reactions (≥10%) in patients receiving DARZALEX FASPRO in combination with lenalidomide and dexamethasone (DRd)1

aFatigue includes asthenia and fatigue.

bUpper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory tract infection viral, rhinitis, sinusitis, upper respiratory tract infection, and upper respiratory tract infection bacterial.

cPneumonia includes lower respiratory tract infection, lung infection, and pneumonia.

dBronchitis includes bronchitis and bronchitis viral.

eDyspnea includes dyspnea and dyspnea exertional.

fCough includes cough and productive cough.

gOnly Grade 3 adverse reactions occurred.

  • The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, pyrexia, cough, muscle spasms, back pain, vomiting, upper respiratory tract infection, peripheral sensory neuropathy, constipation, and pneumonia1

Select laboratory abnormalities worsening from baseline in patients receiving DARZALEX FASPRO combination therapy1

aDenominator is based on the safety population treated with DVMP (n=67) and with DRd (n=65).

Subcutaneous administration starting with the first dose

Pre-medication1

Pre-medicate patients 1 to 3 hours before each dose with histamine-1 receptor antagonist, acetaminophen, and a corticosteroid.

~3 to 5 minute injection1

Post-medication1

Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions* (ARRs).

Monitor patients for systemic ARRs, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) ARRs, immediately and permanently discontinue DARZALEX FASPRO.

*In clinical trials of DARZALEX FASPRO, DARZALEX®, and the Prescribing Information for DARZALEX®, the term "infusion reactions" was used instead of "systemic administration-related reactions".

DARZALEX FASPRO benefits1,2

  • Fixed dose; no weight-based calculations

  • Ready-to-use, single-dose vial

  • Same dosing schedules as DARZALEX® (daratumumab) for approved indications

    Split first dose option for DARZALEX® is not applicable to DARZALEX FASPRO.

  • Formulated with hyaluronidase for subcutaneous administration

For Nurses

Administering DARZALEX FASPRO

To support your efforts in treating patients currently on DARZALEX FASPRO, Janssen provides:

Dosing and Administration Guide

A convenient, comprehensive guide to preparing and administering DARZALEX FASPRO

For Pharmacists

Looking to order DARZALEX FASPRO?

Explore clinical experience with DARZALEX®

Reference(s):

  1. DARZALEX FASPRO [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. DARZALEX® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  3. Mateos M-V, Nahi H, Legiec W, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020. doi: 10.1016/S2352-3026(20)30070-3. [Epub ahead of print]

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