Postmarketing reports include pruritus, acneiform dermatitis, and appetite loss. Dose interruptions/reductions are protocol-driven for Grade ≥2 toxicities.

Multisystem Toxicity Profile of Alpelisib

Common adverse reactions (≥10%) include diarrhea (16%), stomatitis (16%), and hyperglycemia (12%). Grade 3/4 lab abnormalities involve hyperglycemia (11%), hypophosphatemia (5%), and anemia (6%). Severe risks encompass SCARs (permanent discontinuation), pneumonitis (fatal if confirmed), and colitis (steroid intervention). Hyperglycemia may progress to ketoacidosis or HHNKS, necessitating glucose monitoring and anti-hyperglycemic therapy. Other notable effects: alopecia (5%), cellulitis (3.5% Grade 3), and embryofetal harm (preclinical teratogenicity).