DARZALEX® monotherapy

Heavily pre-treated

DARZALEX® monotherapy delivers remarkable efficacy in heavily pre-treated and highly refractory patients[1][2][3]

Study design

DARZALEX® has been studied in two single-arm, phase 1/2 and phase 2 trials, GEN501 and SIRIUS[4][5]


GEN501/SIRIUS: Updated analysis presented at the ASH Annual Meeting 2017

Median follow-up: 36.6 months[3]

Overall survival


Overall response rate


≥ Very good partial response rate


Combined analysis of GEN501 and SIRIUS populations

Safety Profile

DARZALEX® monotherapy offers a manageable tolerability profile[2][3]
  • Only 6 (4.1%) patients in total discontinued the study due to adverse events[2]
  • Manageable infusion-related reactions (IRRs), and caused no discontinuations to treatment[2][6]


DARZALEX® monotherapy dosing schedule: 4-week cycle regimen[1][2]



Dosing schedule

DARZALEX® (daratumumab)

1800 mg SC

Cycles 1–2: Days 1, 8, 15, 22

Cycles 3–6: Days 1, 15

Cycles 7+: Every 4 weeks until disease progression


Monotherapy dosing schedule

(PDF, xx KB)

EHA 2019 update[7]

Results of the DARZALEX® monotherapy early access treatment protocol in patients from Europe and Russia with RRMM

  • A total of 293 heavily pre-treated RRMM patients (Spain, Italy, Russia and United Kingdom) were given early access to DARZALEX® monotherapy
  • Pooled analysis confirmed the tolerability safety profile and efficacy of DARZALEX® monotherapy
  • No new safety concerns were identified, and HRQoL was maintained

Quick downloads

SC Checklist beginning of treatment

Includes a first use checklist of Darzalex® SC.

Darzalex® SC Practical Guide

Includes DARZALEX® SC handling and administration info, pre and post-injection medications, and more

ASH: American Society of Hematology

EHA: European Hematology Association

HRQoL: health-related quality of life

IRR: infusion-related reaction

IV: intravenous

RRMM: relapsed/refractory multiple myeloma

SC: subcutaneous

Titular da Autorização de Introdução no Mercado: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Bélgica.
Para mais informações deverá contactar o Representante do Titular da Autorização de Introdução no Mercado: Janssen-Cilag Farmacêutica, Lda.

Medicamento de receita médica restrita, de utilização reservada a certos meios especializados.

Antes de prescrever consulte o RCM completo.

RCM de Darzalex®, veja aqui

CP-287814 - March 2022