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These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015
Medication labelWhy this: Advisory · dailymed-prescription
ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. Limitations of Use The efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation.
- generic_name
- lumacaftor and ivacaftor
- product_names
- lumacaftor and ivacaftor
- ndc
- 51167-809, 51167-809-01, 51167-700, 51167-700-02, 51167-900, 51167-900-01, 51167-500, 51167-500-02, 51167-122, 51167-122-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en