INDICATIONS AND USAGE
(tezacaftor/ivacaftor and ivacaftor)
is indicated for the treatment of patients with cystic fibrosis
(CF) aged 12 years and older who are homozygous for the F508del
mutation or who have at least one mutation in the cystic fibrosis
transmembrane conductance regulator (CFTR) gene that is responsive to
tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.
If the patient’s genotype is unknown, an FDA-cleared CF mutation test
should be used to detect the presence of a CFTR mutation followed by
verification with bi-directional sequencing when recommended by the mutation
test instructions for use.