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Another NameBylvay,LuciOdevi
IndicationsIt is indicated for the treatment of cholestatic pruritus in patients aged 3 months and older with progressive familial intrahepatic cholestasis (PFIC) and patients aged 12 months and older with Alagi
Reg No.12 L 1278/24
Inspection NO.3155-24
As an oral IBAT inhibitor manufactured by Lucius Pharmaceuticals, this medication provides a targeted treatment option for patients with rare liver diseases and holds favorable clinical application value.
Summary of the Main Information of This Medication
The active ingredient is odevixibat, an inhibitor of the ileal bile acid transporter (IBAT).
It is indicated for patients with progressive familial intrahepatic cholestasis (PFIC) aged 3 months and older, and patients with Alagille syndrome (ALGS) aged 12 months and older.
Administer orally once daily in the morning with food.
For PFIC patients: The initial dose is 40 mcg/kg, which can be increased to 120 mcg/kg based on treatment response.
For ALGS patients: The recommended dose is 120 mcg/kg.
Reference: Dosage and Administration of Odevixibat
Pregnant women: Use with caution, as this drug may cause fetal cardiac malformations.
Lactating women: Monitor fat-soluble vitamin levels during treatment.
Pediatric patients: The safety and efficacy of this drug have been established.
Patients with hepatic insufficiency: Use with caution.
Store the medication at room temperature, and avoid exposure to high temperatures and humid environments.
In terms of pharmacokinetics, odevixibat has extremely low oral absorption, with plasma concentrations mostly below the limit of detection. Co-administration with food can further reduce its absorption.
FDA，2025.03
