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These highlights do not include all the information needed to use BYLVAY safely and effectively. See full prescribing information for BYLVAY. BYLVAY (odevixibat) capsules, for oral use BYLVAY (odevixibat) oral pellets Initial U.S. Approval: 2021
Medication labelWhy this: Advisory · dailymed-prescription
BYLVAY is indicated for the treatment of pruritus in patients 3 months of age and older with PFIC. Limitations of Use BYLVAY is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump (BSEP) protein [see Clinical Pharmacology (12.5) and Clinical Studies (14.1)]. BYLVAY is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with ALGS.
- generic_name
- odevixibat
- product_names
- odevixibat
- ndc
- 74528-020, 74528-040, 74528-060, 74528-120, 74528-020-01, 74528-040-01, 74528-060-01, 74528-120-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en