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]
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Efficacy
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]
Dosing
DARZALEX® monotherapy dosing schedule: 4-week cycle regimen[1][2]
Treatment | Dose | 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
Glossary
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
