Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Minjuvi

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

HOS-147422 · Präparat HOS-099656

Myelosuppression Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia and anaemia (see sections 4.2 and 4.4). In the L-MIND study, myelosuppression (i.e. neutropenia, febrile neutropenia, thrombocytopenia, leukopenia, lymphopenia or anaemia) occurred in 65.4% of patients treated with tafasitamab. Myelosuppression led to interruption of tafasitamab in 41% and to tafasitamab discontinuation in 1.2%. In the inMIND study, myelosuppression (i.e. neutropenia, febrile neutropenia, thrombocytopenia, leukopenia, lymphopenia or anaemia) occurred in 63.3% of patients treated with tafasitamab, lenalidomide, and rituximab (tafasitamab group) and 63.1% of patients treated with lenalidomide and rituximab (placebo group). Grade 4 haematological adverse reactions included neutropenia, thrombocytopenia and febrile neutropenia. Myelosuppression led to interruption of tafasitamab in 42.8% and to tafasitamab discontinuation in 1.5%. Myelosuppression was managed by reduction or interruption of lenalidomide, interruption of tafasitamab and/or rituximab. In addition, severe neutropenia was managed by the administration of GCSF (see sections 4.2 and 4.4).

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