Grade*¶ | RecommendationΔ |
Grade 1 (<10% BSA with active skin toxicity) | - No alpelisib dose adjustment required.
- Initiate topical corticosteroid treatment.
- Consider adding oral antihistamine to manage symptoms.
- If active rash is not improved within 28 days of appropriate treatment, add a low-dose systemic corticosteroid.
- If the etiology is SCAR, permanently discontinue alpelisib.
|
Grade 2 (10 to 30% BSA with active skin toxicity) | - No alpelisib dose adjustment required.
- Initiate or intensify topical corticosteroid and oral antihistamine treatment.
- Consider low-dose systemic corticosteroid treatment.
- If rash improves to grade ≤1 within 10 days, systemic corticosteroid may be discontinued.
- If the etiology is SCAR, permanently discontinue alpelisib.
|
Grade 3 (eg, severe rash not responsive to medical management) (>30% BSA with active skin toxicity) | - Interrupt alpelisib.
- Initiate or intensify topical/systemic corticosteroid and oral antihistamine treatment.
- If the etiology is SCAR, permanently discontinue alpelisib.
- If the etiology is not a SCAR, interrupt dose until improvement to grade ≤1, then resume alpelisib at next lower dose level.
|
Grade 4 (eg, severe bullous, blistering, or exfoliating skin conditions) (any % BSA associated with extensive superinfection, with IV antibiotics indicated; life-threatening consequences) | - Permanently discontinue alpelisib.
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