Indications and Usage

KALYDECO is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.

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.

View the series below.

CFTR Protein Dysfunction and the
Pathophysiologic Effects of Cystic Fibrosis

CFTR Gene Mutations and
CFTR Protein Defects

How KALYDECO® (ivacaftor)
works

Click here for Important Safety Information for KALYDECO® (ivacaftor) and full Prescribing Information.