Alpelisib requires vigilant monitoring for severe hypersensitivity (anaphylaxis), cutaneous reactions (SCARs: SJS, TEN), hyperglycemia (fasting glucose/HbA1c monitoring), pneumonitis (respiratory symptoms), and diarrhea/colitis (hydration, stool monitoring).

Critical Safety Monitoring and Contraindications

Pre-treatment fasting glucose optimization and anti-hyperglycemic agents are mandated. Contraindications include severe hypersensitivity to alpelisib. Embryo-fetal toxicity necessitates contraception in reproductive-age patients (1 week post-treatment). Drug interactions with CYP3A4 inducers (e.g., rifampin) or BCRP inhibitors require avoidance or close monitoring. Pediatric growth/development monitoring is advised due to preclinical dental/bone toxicity.