Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Minjuvi

MINJUVI 200 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11–12

HOS-147425 · Präparat HOS-099656

11 Anaemia In the L-MIND study, incidence of anaemia was 36%. Incidence of Grade 3 or 4 anaemia was 7%. Median duration of any adverse reaction of anaemia was 15 days (range 1 – 535 days); median time to onset to first occurrence of anaemia was 49 days (range 1 – 1129 days). When patients in the L-MIND study were switched from tafasitamab and lenalidomide in the combination therapy phase to tafasitamab alone in the extended monotherapy phase, the incidences of haematological events decreased by at least 20% for neutropenia, thrombocytopenia and anaemia; no incidences of febrile neutropenia were reported with tafasitamab monotherapy (see sections 4.2 and 4.4). In the inMIND study, incidence of anaemia was 17.1% in the tafasitamab group (tafasitamab, lenalidomide and rituximab) and 14.5% in the placebo group (lenalidomide and rituximab). Incidence of Grade 3 or 4 anaemia was 6.4% in the tafasitamab group and 6.5% in the placebo group. Median duration of any adverse reaction of anaemia was 23 days (range 1 – 432 days); median time to onset to first occurrence of anaemia was 49 days (range 1 – 274 days).

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