INDICATIONS:Postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH: Breast Cancer Resistance Protein inhibitors, CYP2C9 substrates, CYP3A4 inducers
PREGNANCY: Based on animal data and mechanism of action can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug associated risk. When used in combination with fulvestrant, refer to the prescribing information of fulvestrant for pregnancy information.