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These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO. SYMDEKO® (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral useInitial U.S. Approval: 2018
Medication labelWhy this: Advisory · dailymed-prescription
SYMDEKO is indicated for the treatment of cystic fibrosis (CF) in patients aged 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 [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
- tezacaftor and ivacaftor
- brand_name
- Ivacaftor
- product_names
- Tezacaftor and Ivacaftor, Ivacaftor
- ndc
- 51167-661, 51167-661-01, 51167-113, 51167-113-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en