INDICATIONS AND USAGE
(tezacaftor/ivacaftor and ivacaftor)
is indicated for the treatment of patients with cystic fibrosis (CF) age 6 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.