Nebenwirkungen · Kalydeco
Kalydeco 75 mg film-coated tablets Kalydeco 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-126463 · Präparat HOS-096263
During the placebo-controlled phase 3 studies (up to 24 weeks) of tezacaftor/ivacaftor, the incidence of maximum transaminase (ALT or AST) > 8, > 5, or > 3 × ULN were 0.2%, 1.0%, and 3.4% in tezacaftor/ivacaftor-treated patients, and 0.4%, 1.0%, and 3.4% in placebo-treated patients. One patient (0.2%) on therapy and 2 patients (0.4%) on placebo permanently discontinued treatment for elevated transaminases. No patients treated with tezacaftor/ivacaftor experienced a transaminase elevation > 3 × ULN associated with elevated total bilirubin > 2 × ULN.
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Version 2025-07-02T15:40:00Z · SHA-256 3213de37cc075be5d4409b79807f1ec8017896be60e7edb796dfbe660a1e4b9f · Passage 2f10ab26e79c8885e6d59786f3d84c81fe069b85f1ca93aaff0b342a1e11858c · Zeichen 7803–8357 im Abschnitt