In combination w/ endocrine therapy as adjuvant treatment for adults w/ hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve, node +ve early breast cancer at high risk of recurrence. In combination w/ aromatase inhibitor as initial endocrine-based therapy for postmenopausal women w/ HR +ve, HER2 -ve advanced or metastatic breast cancer; in combination w/ fulvestrant for women w/ HR +ve, HER2 -ve advanced or metastatic breast cancer w/ disease progression following endocrine therapy.
150 mg bd w/ fulvestrant, tamoxifen or aromatase inhibitor. Early breast cancer Continue treatment for 2 yr until disease progression or unacceptable toxicity. Advanced or metastatic breast cancer Continue treatment until disease recurrence or unacceptable toxicity. Severe hepatic impairment (Child-Pugh C) Reduce frequency to once daily.
Discontinue use until toxicity resolves to ≤grade 1 then resume at next lower dose for grade 3 or 4, or diarrhea that requires hospitalization; grade 3 or 4 ILD/pneumonitis. Start antidiarrheal therapy & increase fluid intake at 1st sign of loose stools. Monitor CBC & LFTs prior to therapy, every 2 wk for 1st 2 mth, then mthly for next 2 mth; pulmonary symptoms indicative of ILD/pneumonitis; signs & symptoms of venous thrombosis & pulmonary embolism. Avoid concomitant use w/ ketoconazole, grapefruit products. Severe renal impairment (CrCl <30 mL/min), ESRD or patients on dialysis; severe hepatic impairment (Child-Pugh C). May impair male fertility. Women of childbearing potential should use effective contraception during & for 3 wk after last dose. Pregnancy. Not to be used during lactation. Ped patients.
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