Active Ingredient: Odevixibat
Odevixibat is indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient age in months is ≥ 6
Oral, 120 micrograms odevixibat per kilogram of body weight, once daily at morning.
The recommended dose of odevixibat is 120 mcg/kg administered orally once daily in the morning.
Dose reduction to 40 mcg/kg/day may be considered if tolerability issues (diarrhoea that lasts ≥3 days, is considered severe, or requires IV hydration) occur in the absence of other causes. Once tolerability issues stabilise, the dose should 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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