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.
Permanently discontinue use if severe hypersensitivity occurs; pneumonitis or severe cutaneous adverse reactions eg, SJS, erythema multiforme, TEN or DRESS is confirmed. Patients w/ type 1 & uncontrolled type 2 diabetes; severe diarrhea or colitis. Severe hyperglycemia associated w/ hyperglycemic hyperosmolar non-ketotic syndrome (HHNKS) or ketoacidosis. Monitor blood &/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 of childbearing potential & male partners should use effective contraception during & for 1 wk after last dose. Pregnancy. Not to be used during lactation & for 1 wk after last dose. Ped.
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