Nebenwirkungen · Akeega
Akeega 50 mg/500 mg film-coated tablets Akeega 100 mg/500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-150314 · Präparat HOS-100288
Summary of the safety profile The overall safety profile of Akeega is based on pooled data from two clinical Phase 3 trials with 559 patients (AMPLITUDE [n=347] and MAGNITUDE cohort 1 [n=212]). The most common adverse reactions of all grades occurring in >10% in the niraparib plus AAP arm were anaemia (51.9%), hypertension (40.1%), fatigue (39.7%), musculoskeletal pain (35.8%), constipation (34.7%), nausea (28.6%), hypokalaemia (22.0%), thrombocytopenia (20.9%), neutropenia (19.7%), oedema (18.1%), respiratory tract infections (17.7%), dyspnoea (16.6%), vomiting (15.7%), decreased appetite (15.0%), leukopenia (14.5%), hot flush (14.1%), dizziness (14.0%), weight decreased (14.0%), abdominal pain (13.4%), hyperglycaemia (13.4%), insomnia (13.1%), diarrhoea (12.3%), lymphopenia (12.2%), headache (12.0%), blood creatinine increased (11.8%), urinary tract infection (11.8%), and cough (10.4%). The most frequently observed Grade 3-4 adverse reactions were anaemia (29.7%), hypertension (22.7%), hypokalaemia (9.3%), neutropenia (8.4%), thrombocytopenia (7.5%), and lymphopenia (5.2%).
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