In combination w/ fulvestrant for postmenopausal women & men w/ hormone-receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after endocrine-based regimen.
Discontinue use if severe hypersensitivity occurs; pneumonitis or severe cutaneous ARs eg, SJS, TEN or DRESS is confirmed. Patients w/ type 1 & uncontrolled type 2 diabetes; severe diarrhea. Severe hyperglycemia associated w/ hyperglycemic hyperosmolar non-ketotic syndrome or ketoacidosis. Monitor new or worsening resp symptoms; blood glucose &/or fasting plasma glucose at least once every wk for 1st 2 wk, then at least once every 4 wk & as clinically indicated; HbA1c every 3 mth & as clinically indicated. Ensure adequate fluid intake. Severe renal impairment. May impair female & male fertility. Women & men of childbearing potential should use effective contraception during & for 1 wk after last dose. Pregnancy. Not to be used during lactation. Ped.
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