In combination w/ aromatase inhibitor as initial therapy for pre/peri- or postmenopausal women or men w/ hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve advanced or metastatic breast cancer. In combination w/ fulvestrant as initial or following disease progression therapy for postmenopausal women or men w/ HR +ve, HER2 -ve advanced or metastatic breast cancer.
Adult 600 mg once daily for 21 consecutive days followed by 7 days off-treatment to complete 28-day cycle.Severe renal impairment Initially 200 mg once daily. Moderate or severe hepatic impairment Initially 400 mg once daily.
Discontinue use if SJS, TEN or DRESS is confirmed. Avoid use in patients w/ or at significant risk of QT prolongation. Neutropenia. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Perform CBC & LFTs; assess ECG & monitor serum electrolytes eg, K, Ca, P & Mg prior to treatment. Avoid drugs prolonging QT interval &/or strong CYP3A inhibitors. Not recommended in concomitant use w/ tamoxifen. Breast cancer patients w/ severe renal impairment. May impair male fertility. Women of childbearing potential should use effective contraception during treatment & for at least 3 wk after last dose. Pregnancy. Not to be used during lactation & for at least 3 wk after last dose. Ped.
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