Kalydeco is approved for the treatment of CF in patients age six years and older who have the specific G551D mutation in the cystic fibrosis transmembrane regulator (CFTR) gene. In patients with the G551D mutation, Kalydeco helps the protein made by the CFTR gene function better and, as a result, improves lung function and other aspects of CF such as increasing weight gain.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.
FDA Notification to the Cystic Fibrosis Community on Kalydeco (ivacaftor)
FDA approves Kalydeco to treat rare form of cystic fibrosis[ARCHIVED]
FDA news release (1/31/2012)