INDICATIONS AND USAGE
SYMDEKO® (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.