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
Combined analysis of GEN501 and SIRIUS populations
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)
Results of the DARZALEX® monotherapy early access treatment protocol in patients from Europe and Russia with RRMM
Includes a first use checklist of Darzalex® SC.
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