Table 2.

Side-effects of alpelisib and management

Side-effect	Reported incidence of any gradea	Supportive treatment(s)
Hyperglycemia	65%	Metformin 500 mg once daily. Dose can be titrated every 7 days by increasing to 500 mg twice daily then increasing each dose by additional 500 mg as needed up to maximum dose of 2000 mg daily. If not controlled on max metformin dose, consultation with endocrinologist recommended for addition of an insulin-sensitizer agent such as pioglitazone and/or insulin therapy For glucose >250, i.v. hydration, correction of electrolyte abnormalities, drug interruption until glucose improves For glucose >500, the above measures with insulin therapy; if glucose does not improve within 24 h, discontinue alpelisib
Rash	54%	For mild rash, topical steroids (triamcinolone, betamethasone) 3–4 times daily If rash does not resolve or covers 10%–30% BSA, low-dose systemic steroids (prednisone 20–40 mg day for up to 10 days) Drug interruption necessary if rash not responding to above measures For pruritus, non-drowsy antihistamines orally twice a day can be used; hydroxyzine or diphenhydramine at bedtime
Diarrhea	58%	First line: Loperamide, initial administration of 4 mg, then 2 mg every 4 h (maximum of 16 mg/day) at the first sign of loose stool or symptoms of abdominal pain. Second line: octreotide acetate subcutaneous 100–150 µg every 8 h; opium tincture 10–15 drops (10 mg/ml) in water every 3–4 h
Stomatitis	25%	Dexamethasone 0.5 mg/5 ml oral solution (swish for 2 min and spit, four times daily) for a minimum of 8 weeks as prophylaxis
Pneumonitis	2%	High-dose systemic corticosteroids Drug discontinuation

^aBased on data from SOLAR-1 phase III clinical trial and report from the Food and Drug Administration [13].