Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Kalydeco

Kalydeco 75 mg film-coated tablets Kalydeco 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-126456 · Präparat HOS-096263

Table 4 reflects the adverse reactions observed with ivacaftor monotherapy in clinical trials (placebo- controlled and uncontrolled studies) in which the length of exposure to ivacaftor ranged from 16 weeks to 144 weeks. Additional adverse reactions observed with ivacaftor in a combination regimen with tezacaftor/ivacaftor and/or in a combination regimen with ivacaftor/tezacaftor/elexacaftor are also provided in Table 4. The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

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