In combination w/ fulvestrant for postmenopausal women & men w/ hormone-receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after endocrine-based regimen.
Discontinue use if severe hypersensitivity occurs; if pneumonitis is confirmed. Not to be initiated in patients w/ history of Stevens-Johnson syndrome, erythema multiforme or toxic epidermal necrolysis. Patients w/ type 1 & uncontrolled type 2 diabetes; severe diarrhea. Monitor new or worsening resp symptoms. Ensure adequate fluid intake. Monitor 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. 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 & lactation. Paed patients. Elderly ≥75 yr.
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