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Odevixibat

Also known as: Bylvay

Ileal Bile Acid Transporter InhibitorIleal Bile Acid Transporter Inhibitors

Route: Oral

3 interactions on record

Odevixibat has 3 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Cholestyramine Light, Colesevelam, Colestipol. Patients taking Odevixibat should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 3
Moderate: 3

Moderate (3)

Odevixibat + Cholestyramine Light— Bile acid binding resins may bind odevixibat in the gut, reducing BYLVAY efficacy. Administer at least 4 hours before or…
Odevixibat + Colesevelam— Bile acid binding resins may bind odevixibat in the gut, reducing BYLVAY efficacy. Administer at least 4 hours before or…
Odevixibat + Colestipol— Bile acid binding resins may bind odevixibat in the gut, reducing BYLVAY efficacy. Administer at least 4 hours before or…

Odevixibat + Cholestyramine Light🟡Moderate

Bile acid binding resins may bind odevixibat in the gut, reducing BYLVAY efficacy. Administer at least 4 hours before or after odevixibat.

Odevixibat + Colesevelam🟡Moderate

Bile acid binding resins may bind odevixibat in the gut, reducing BYLVAY efficacy. Administer at least 4 hours before or after odevixibat.

Odevixibat + Colestipol🟡Moderate

Bile acid binding resins may bind odevixibat in the gut, reducing BYLVAY efficacy. Administer at least 4 hours before or after odevixibat.

Contraindications

4 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) ] . Patients with prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy). ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Limited human data on the use of BYLVAY in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes. Based on findings from animal reproduction studies, BYLVAY may cause cardiac malformations when a fetus is exposed during pregnancy. In pregnant rabbits treated orally with odevixibat during organogenesis, an increased incidence of malformations in fetal heart, great blood vessels, and other vascular sites occurred at all doses; maternal systemic exposure at the lowest dose was 2.1 times the maximum recommended dose (see Data ) . Odevixibat may inhibit the absorption of fat-soluble vitamins. FSV are essential for normal fetal growth and development. Monitor pregnant patients for FSV deficiency and supplement as needed. Increased supplementation of FSVs may be needed during pregnancy [see Warnings and Precautions (5.3) and Clinical Considerations ] . Consider the woman's need for BYLVAY, the potential drug-related risks to the fetus, and the potential adverse outcomes from untreated maternal PFIC and ALGS. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There is a pregnancy safety study that monitors pregnancy outcomes in women exposed to BYLVAY during pregnancy. Pregnant women exposed to BYLVAY, or their healthcare providers, should report BYLVAY exposure by calling 1-855-463-5127. Clinical Considerations Fetal/Neonatal Adverse Reactions Odevixibat may inhibit the absorption of fat-soluble vitamins (FSV). Monitor pregnant patients for FSV deficiency and supplement as needed. Increased supplementation of FSVs may be needed during pregnancy [see Warnings and Precautions (5.3) ]. Data Animal Data In an embryo-fetal development

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.