Nebenwirkungen · Libtayo
LIBTAYO 350 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 15
HOS-142318 · Präparat HOS-098800
Immune-mediated colitis Immune-mediated diarrhoea or colitis occurred in 25 (2.0%) of 1281 patients receiving cemiplimab, including 10 (0.8%) with Grade 3 immune-mediated diarrhoea or colitis. Immune-mediated diarrhoea or colitis led to permanent discontinuation of cemiplimab in 5 (0.4%) of 1281 patients. Among the 25 patients with immune-mediated diarrhoea or colitis, the median time to onset was 3.8 months (range: 1 day to 16.6 months) and the median duration of immune-mediated diarrhoea or colitis was 2.1 months (range: 4 days to 26.8 months). Nineteen of the 25 patients (76.0%) with immune-mediated diarrhoea or colitis received high-dose corticosteroids for a median of 22 days (range: 2 days to 5.2 months). Resolution of immune-mediated diarrhoea or colitis had occurred in 14 (56.0%) of the 25 patients at the time of data cutoff.
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Version 2025-12-10T09:43:00Z · SHA-256 e26a4d46dee107273416cff167125ea4a2d57ae4635bf68f860ceb24b87bd4b6 · Passage d88c49a9a512f499d5b968fdd2931fda5a45f41f68026cd1819ddf20059a90e8 · Zeichen 16758–17603 im Abschnitt