Odevixibat (1 brand name, 2 dosage forms, 1 route)
Available dosage forms: CAPSULE, PELLETS, CAPSULE.
Routes of administration: ORAL.
Brand Names
- BYLVAY
Contraindications
IBAT inhibitors, including BYLVAY, are contraindicated in patients with prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) [see Warnings and Precautions (5.1)].
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the label: Hepatotoxicity [see Warnings and Precautions (5.1) ] Diarrhea [see Warnings and Precautions (5.2)] Fat-Soluble Vitamin Deficiency [see Warnings and Precautions (5.3)]
Mechanism of Action
Odevixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum. Pruritus is a common symptom in patients with PFIC and ALGS; the pathophysiology of pruritus in patients with PFIC is not completely understood. Although the complete mechanism by which odevixibat improves pruritus in both PFIC and ALGS patients is unknown, it may involve inhibition of the IBAT, which results in decreased reuptake of bile salts, as observed by a decrease in serum bile acids [see Clinical Pharmacology (12.2)].