Dose modification and management for diarrhea with alpelisib

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

CTCAE: Common Terminology Criteria for Adverse Events.

* Grading according to CTCAE Version 5.0.

¶ For grade 2 and 3 colitis, consider additional treatment, such as enteric-acting and/or systemic steroids.

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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