Nebenwirkungen · Retsevmo
Retsevmo 40 mg hard capsules Retsevmo 80 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14
HOS-146860 · Präparat HOS-099572
Aminotransferase elevations (AST / ALT increased) Based on laboratory assessment, ALT and AST elevations were reported in 59.4% and 61% patients, respectively. Grade 3 or 4 ALT or AST elevations were reported in 14.1% and 9.5% patients respectively. The median time to first onset was: AST increase 4.7 weeks (range: 0.7, 227.9), ALT increase 4.4 weeks (range: 0.9, 186.1) in LIBRETTO-001, AST increase 5.1 weeks (range: 0.7, 88.1), ALT increase 5.1 weeks (range: 0.7, 110.9) in LIBRETTO-431, and AST increase 6.1 weeks (range: 0.1, 85.1), ALT increase 6.1 weeks (range: 0.1, 85.1) in LIBRETTO-531. Dose modification is recommended for patients who develop Grade 3 or 4 ALT or AST increase (see section 4.2).
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Version 2026-07-03T11:29:00Z · SHA-256 ea39918a3fb80726ed18974b1aa44d085db9e48e01020d5741da30903ff4eadc · Passage 4f1c2c48ef0d695266df0988be25c1fde02f818b2d9a9a5aa209444b70808df5 · Zeichen 12133–12841 im Abschnitt