BYLVAY (ODEVIXIBAT)
BYLVAY (ODEVIXIBAT) is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: BYLVAY; Generic name: ODEVIXIBAT; Drug class: Ileal Bile Acid Transporter Inhibitor [EPC].
| Brand name | BYLVAY |
|---|---|
| Generic name | ODEVIXIBAT |
| Drug class | Ileal Bile Acid Transporter Inhibitor [EPC] |
| Manufacturer | Albireo Pharma, Inc. |
| Used for | 1 INDICATIONS AND USAGE BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for: Progressive Familial Intrahepatic Cholestasis (PFIC) the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). ( 1.1 ) Limitation 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 protein. ( 12.5 , 14.1 ) Alagille Syndrome (ALGS) the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille syndrome (ALGS). ( 1.2 ) 1.1 Progressive Familial Intrahepatic Cholestasis (PFIC) BYLVA |
| Dosage | 2 DOSAGE AND ADMINISTRATION Recommended Dosage PFIC: Patients 3 months and older: 40 mcg/kg taken orally once daily. ( 2.1 ) If there is no improvement in pruritus after 3 months, the dosage may be increased in 40 mcg/kg increments up to 120 mcg/kg once daily, not to exceed a daily dosage of 6 mg/day. ( 2.1 ) ALGS: Patients 12 months and older: 120 mcg/kg taken orally once daily. ( 2.2 ) Preparation and Administration Instructions Administer BYLVAY in the morning with a meal. ( 2.4 ) Do not crus |
| Active ingredient(s) | ODEVIXIBAT |
| Route | ORAL |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=151f1d3e-2bf4-47ce-b1be-a892de3258fa |