Ivacaftor, Tezacaftor and Elexacaftor

Therapeutic indications

Ivacaftor, Tezacaftor and Elexacaftor is indicated for:

Cystic fibrosis at least one F508del mutation in the CFTR gene

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

Ivacaftor/tezacaftor/elexacaftor fixed-dose combination is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

60 mg/40 mg/80 mg, 75 mg/50 mg/100 mg or 150 mg/100 mg/200 mg of ivacaftor/tezacaftor/elexacaftor once daily based on age and body weight

150 mg of ivacaftor, 100 mg of tezacaftor and 200 mg of elexacaftor once daily

Contraindications

Ivacaftor, Tezacaftor and Elexacaftor is contraindicated in the following cases:

Lactation

Severe hepatic impairment

Hepatic failure stage IV

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