Nebenwirkungen · Keytruda
KEYTRUDA 395 mg solution for injection KEYTRUDA 790 mg solution for injection · Abschnitt 4.8 · PDF-Seite 175
HOS-131845 · Präparat HOS-097138
Pembrolizumab in monotherapy (see section 4.2) The safety of intravenous pembrolizumab as monotherapy has been evaluated in 7 631 patients across tumour types and across four doses (2 mg/kg bw every 3 weeks, 200 mg every 3 weeks, or 10 mg/kg bw every 2 or 3 weeks) in clinical studies. In this patient population, the median observation time was 8.5 months (range: 1 day to 39 months) and the most frequent adverse reactions with pembrolizumab were fatigue (31%), diarrhoea (22%), and nausea (20%). The majority of adverse reactions reported for monotherapy were of Grades 1 or 2 severity. The most serious adverse reactions were immune-mediated adverse reactions and severe infusion-related reactions (see section 4.4). The
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