Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Venclyxto

Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15

HOS-135206 · Präparat HOS-097674

The safety of venetoclax in combination with acalabrutinib with or without obinutuzumab was assessed in AMPLIFY, a randomised, controlled study of 575 patients with previously untreated CLL without del (17p) or TP53 mutation. Of the 291 patients treated with venetoclax in combination with acalabrutinib, the most commonly occurring reactions (≥20%) of any grade were infections, neutropenia, headache, bruising, diarrhoea and musculoskeletal pain. The most commonly reported Grade ≥3 adverse reaction (≥5%) was neutropenia. Of the 284 patients treated with venetoclax in combination with acalabrutinib and obinutuzumab, the most commonly occurring adverse reactions of any grade (≥20%) were infections, neutropenia, headache, bruising, diarrhoea, nausea and musculoskeletal pain. The most commonly reported Grade ≥3 adverse reactions (≥5%) were neutropenia and thrombocytopenia.

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