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These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO® (ivacaftor) tablets, for oral useKALYDECO® (ivacaftor) oral granulesInitial U.S. Approval: 2012
Medication labelWhy this: Advisory · dailymed-prescription
KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data [see Clinical Pharmacology (12.1) and Clinical Studies (14)]. 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.
- generic_name
- ivacaftor
- product_names
- ivacaftor
- ndc
- 51167-200, 51167-200-01, 51167-200-02, 51167-300, 51167-300-01, 51167-400, 51167-400-01, 51167-600, 51167-600-01, 51167-770, 51167-770-01, 51167-785, 51167-785-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en