Nebenwirkungen · Akeega
Akeega 50 mg/500 mg film-coated tablets Akeega 100 mg/500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14
HOS-150333 · Präparat HOS-100288
Hepatotoxicity The overall incidence of hepatotoxicity was similar for the niraparib plus AAP (13.6%) and placebo plus AAP (17.5%) arms (see sections 4.2 and 4.4). The majority of these events were low grade aminotransferase elevations. Grade 3 events occurred in 2.0% of patients in the niraparib plus AAP arm and there was one (0.2%) patient with a Grade 4 event and one (0.2%) patient with a Grade 5 event. The incidence of serious adverse events (SAEs) was 0.7%. The median time to onset of hepatotoxicity was 43 days. Hepatotoxicity was managed with dose interruptions in 2.0% and dose reduction in 0.7% of patients. Discontinuation occurred in 0.5% of patients.
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