Dose modification and management for other toxicities with alpelisib (excluding hyperglycemia, rash and severe cutaneous adverse reactions, and diarrhea)

Grade*	Recommendation
Grade 1 or 2	No alpelisib dose adjustment is required. Initiate appropriate medical therapy and monitor as clinically indicated.^¶^Δ
Grade 3	Interrupt alpelisib dose until improvement to grade ≤1, then resume alpelisib at the next-lower dose level.
Grade 4	Permanently discontinue alpelisib.

CTCAE: Common Terminology Criteria for Adverse Events.
* Grading according to CTCAE Version 5.0.
¶ For grade 2 and 3 pancreatitis, interrupt alpelisib dose until improvement to grade <2 and resume at next lower-dose level. Only one dose reduction is permitted. If toxicity reoccurs, permanently discontinue alpelisib treatment.
Δ For grade 2 total bilirubin elevation, interrupt alpelisib dose until improvement to grade ≤1 and resume at the same dose if resolved in ≤14 days or resume at the next-lower dose level if resolved improved in >14 days.

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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Dose modification and management for other toxicities with alpelisib (excluding hyperglycemia, rash and severe cutaneous adverse reactions, and diarrhea)