Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Minjuvi

MINJUVI 200 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8

HOS-147408 · Präparat HOS-099656

Summary of the safety profile Patients with relapsed or refractory DLBCL The safety of tafasitamab in patients with DLBCL was evaluated in the open-label, multicentre, single- arm phase 2 study L-MIND in 81 patients with relapsed or refractory DLBCL. Patients received tafasitamab 12 mg/kg intravenously in combination with lenalidomide for a maximum of 12 cycles, followed by tafasitamab monotherapy until disease progression or unacceptable toxicity. The median duration of exposure to tafasitamab was 7.7 months. The most common adverse reactions were: infections (73%), neutropenia (51%), asthenia (40%), anaemia (36%), diarrhoea (36%), thrombocytopenia (31%), cough (26%), oedema peripheral (24%), pyrexia (24%), decreased appetite (22%). The most common serious adverse reactions were infection (26%) including pneumonia (7%), and febrile neutropenia (6%). Permanent discontinuation of tafasitamab due to an adverse reaction occurred in 15% of patients. The most common adverse reactions leading to permanent discontinuation of tafasitamab were infections and infestations (5%), nervous system disorders (2.5%), and respiratory, thoracic and mediastinal disorders (2.5%). The frequency of dose modification or interruption due to adverse reactions was 65%. The most common adverse reactions leading to tafasitamab treatment interruption were blood and lymphatic system disorders (41%).

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