Answer
No clinically important differences in intravenous daratumumab exposure were observed in multiple myeloma patients with mild, moderate or severe renal impairment or end-stage renal disease versus normal renal function in four population pharmacokinetic analyses, although no formal renal-impairment studies were conducted.
Sources for this answer
- DARZALEX 20 mg/mL concentrate for solution for infusionJanssen-Cilag Ltd (a Johnson & Johnson Company) · emc · SmPC §5.2 Pharmacokinetic properties · Version 36Document updated
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