Nebenwirkungen · Zykadia
Zykadia 150 mg hard capsules · Abschnitt 4.8 · PDF-Seite 10–11
HOS-131713 · Präparat HOS-097124
Grade 3-4 ADRs with an incidence of ≥5% in patients treated with ceritinib 750 mg fasted were liver laboratory test abnormalities, fatigue, vomiting, hyperglycaemia, nausea and diarrhoea. 10 In the dose optimisation study A2112 (ASCEND-8) in both previously treated and untreated patients with ALK-positive advanced NSCLC, the overall safety profile of ceritinib at the recommended dose of 450 mg with food (N=108) was consistent with ceritinib 750 mg fasted (N=110), except for a reduction in gastrointestinal adverse drug reactions, while achieving comparable steady-state exposure (see section 5.1 and subsection ‘Gastrointestinal adverse reactions’ below).
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