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Dose modification and management of alpelisib for rash and severe cutaneous adverse reactions

Dose modification and management of alpelisib for rash and severe cutaneous adverse reactions
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.
SCARs: severe cutaneous adverse reactions; BSA: body surface area; CTCAE: Common Terminology Criteria for Adverse Events.
* Grading according to CTCAE Version 5.0.
¶ For all grades of rash, consider consultation with a dermatologist.
Δ Antihistamines administered prior to rash onset may decrease incidence and severity of rash based on the SOLAR-1 trial.
Reproduced from: Alpelisib tablets. United States Prescribing Information. US National Library of Medicine. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212526Orig1s004lbl.pdf (Accessed on July 23, 2021).
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