Active Ingredient: Leniolisib
Leniolisib is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient age in years is ≥ 12 and patient weight is ≥ 45 kg, oral, 70 milligrams leniolisib, once every 12 hours.
The recommended dosage of leniolisib in adult and pediatric patients 12 years of age and older weighing 45 kg or greater is 70 mg administered orally twice daily approximately 12 hours apart, with or without food. There is no recommended dosage for patients weighing less than 45 kg.
Advise patients that if a dose is missed by more than 6 hours, wait and take the next dose at the usual time.
Advise patients that if vomiting occurs within 1 hour after taking leniolisib, take leniolisib as soon as possible. If vomiting occurs more than 1 hour after dosing, wait and take the next dose at the usual time.
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