Alpelisib is administered orally once daily with food, with adult patients receiving 250 mg and pediatric patients (2 to <18 years) starting at 50 mg, adjustable based on age and clinical response.
Structured Dosing Regimen for PROS Management
For pediatric patients ≥6 years, a dose increase to 125 mg may occur after 24 weeks. Dosage forms include 50 mg, 125 mg, and 200 mg tablets or 50 mg oral granules. Tablets must be swallowed whole or prepared as a suspension if needed, while granules are single-use packets. Dose reductions (e.g., to 125 mg or 50 mg for adults; 50 mg for pediatrics) or discontinuation are required for severe adverse reactions (e.g., hyperglycemia, pneumonitis). Missed doses can be taken within 9 hours; vomiting mandates skipping the dose.