ODEVIXIBAT

Other

Brand names: Bylvay

Oral

Mechanism of Action

12.1 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) ] .

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS IBAT inhibitors
• including BYLVAY
• are contraindicated in patients with prior or active hepatic decompensation events (e.g.
• variceal hemorrhage
• ascites

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hepatoxicity : Obtain baseline liver tests and monitor patients frequently for the first 6 to 8 months after starting therapy, and as clinically indicated thereafter during treatment
IBAT inhibitors, including BYLVAY, are contraindicated in patients with prior or active hepatic decompensation events [see Contraindications (4) ]
If FSV deficiency persists or worsens despite adequate FSV supplementation, consider permanent discontinuation of BYLVAY depending on the benefit and risk balance

Known Side Effects

6 documented side effects by frequency

Diarrhea

>10%

Itching

>10%

Drug Not Working

1-10%

Abdominal Pain

1-10%

Vomiting

0.1-1%

Nausea

0.1-1%

Community Discussions

No community discussions found for ODEVIXIBAT yet.

Compare With

0 available comparisons

No comparisons yet.

Formulations

Dosage Forms

Tablet

Route

Oral