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These highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA® (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA® (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019
Medication labelWhy this: Advisory · dailymed-prescription
TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on clinical and/or in vitro data (see Table 6) [see Clinical Pharmacology (12.1)]. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one indicated mutation [see Clinical Pharmacology (12.1)].
- generic_name
- elexacaftor, tezacaftor, and ivacaftor
- brand_name
- Ivacaftor
- product_names
- Elexacaftor, Tezacaftor, and Ivacaftor, Ivacaftor
- ndc
- 51167-331, 51167-331-01, 51167-431, 51167-431-14, 51167-531, 51167-531-07, 51167-106, 51167-106-02, 51167-206, 51167-206-14, 51167-306, 51167-306-07, 51167-445, 51167-445-01, 51167-545, 51167-545-07, 51167-645, 51167-645-07, 51167-446, 51167-446-01, 51167-746, 51167-746-07, 51167-846, 51167-846-07
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en