Drug Interaction Report

ADJUST DOSING INTERVAL: Bile acid binding resins such as cholestyramine colesevelam, or colestipol may bind odevixibat in the gastrointestinal tract, which may reduce odevixibat efficacy.

MANAGEMENT: Odexivibat should be administered at least four hours before or four hours after bile-acid binding resins such as cholestyramine, colestipol, and colesevelam. Patients receiving this combination should be advised to closely follow dosing schedules to prevent loss of therapeutic effects.

MONITOR: Odevixibat may affect absorption of fat-soluble vitamins (FSV) including vitamin A, D, E, and K. In clinical studies, new onset or worsening of existing FSV deficiency was reported in 5% of placebo-treated patients, and in 16% of odevixibat-treated 120 mcg/kg/day patients. However, none of the odevixibat-treated 40 mcg/kg/day patients had new onset or worsening of existing FSV deficiency.

MANAGEMENT: Clinical and laboratory monitoring of FSV levels is recommended at baseline and during treatment with odevixibat. If FSV deficiency is diagnosed, supplement with FSV. Odevixibat should be discontinued if FSV deficiency persists or worsens despite adequate FSV supplementation.