Active Ingredient: Odevixibat
Odevixibat is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 40 micrograms odevixibat per kilogram of body weight, once daily at morning, over the duration of 3 months. Afterwards, oral, between 40 micrograms odevixibat per kilogram of body weight and 120 micrograms odevixibat per kilogram of body weight, once daily at morning.
The recommended dose of odevixibat is 40 mcg/kg administered orally once daily in the morning. Odevixibat can be taken with or without food.
Improvement in pruritus and reduction of serum bile acid levels may occur gradually in some patients after initiating odevixibat therapy. If an adequate clinical response has not been achieved after 3 months of continuous therapy, the dose may be increased to 120 mcg/kg/day.
Alternative treatment should be considered in patients for whom no treatment benefit can be established following 6 months of continuous daily treatment with odevixibat.
If a dose of odevixibat is missed, the patient should take the forgotten dose as soon as possible without exceeding one dose per day.
To be taken with or without food in the morning.
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