Active Ingredient: Leniolisib
Leniolisib is indicated for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In the case that patient weight is ≥ 45 kg :
Oral, 70 milligrams leniolisib, once every 12 hours.
The recommended dose is 70 mg leniolisib twice daily approximately 12 hours apart. Leniolisib is indicated in adults and adolescents 12 years of age and older and weighing 45 kg or more.
Treatment should be continued as long as a benefit is observed or until unacceptable toxicity occurs.
If a dose is missed by more than 6 hours, the patient should not take the missed dose but resume dosing at the next scheduled time.
If vomiting occurs within 1 hour after taking leniolisib, the patient should take another leniolisib tablet as soon as possible. If vomiting occurs more than 1 hour after dosing, the patient should not take an additional dose.
There are no data on patients aged 65 years and older. No dosing modifications are recommended for elderly patients.
For patients using locally acting antacids chronically, the antacid should be taken either 2 hours before or 2 hours after leniolisib administration.
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