Hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve advanced or metastatic breast cancer in combination w/ an aromatase inhibitor as initial endocrine-based therapy; fulvestrant in patients who have received prior therapy.
Dose interruption/reduction or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. Anemia, thrombocytopenia has been reported. Permanently discontinue therapy in patients w/ severe interstitial lung disease or pneumonitis. Monitor CBC prior to start of therapy & at the beginning of each cycle, as well as on Day 15 of the 1st 2 cycles & as clinically indicated. Monitor patients for signs & symptoms of infection or any episodes of fever. Consider sperm preservation prior to beginning of therapy in men. Potential to impair reproductive function & fertility in males. May affect ability to drive & use machines. Hepatic & renal impairment. Pregnancy & lactation. Women of childbearing potential. Childn & adolescent ≤18 yr.
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