1st-line treatment in postmenopausal women w/ hormone-dependent advanced breast cancer. Advanced breast cancer after relapse or disease progression in women w/ natural or artificially induced postmenopausal endocrine status who have previously been treated w/ anti-estrogens. Adjuvant treatment of postmenopausal women w/ hormone receptor +ve invasive early breast cancer. Extended adjuvant treatment of invasive early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 yr.
Adult 2.5 mg once daily. Continue for 5 yr or until disease relapse/recurrence occurs, whichever comes 1st in the adjuvant & extended adjuvant setting. Continue until tumor progression is evident in patients w/ metastatic disease.
Not for hormone-receptor -ve disease. Monitor overall bone health during treatment; possible osteoporosis &/or bone fractures. Measure LH, FSH &/or estradiol levels in patients w/ unclear menopausal status. May lead to increased feedback in gonadotropin (LH, FSH) levels in premenopausal women; may induce ovulation. Avoid co-administration w/ tamoxifen, other anti-estrogens or estrogen-containing therapies. Consider potential risk/benefit in renal impairment (CrCl <10 mL/min) before administration. Closely supervise patients w/ severe hepatic impairment (Child-Pugh score C), systemic exposure & approx doubled terminal t½. Fatigue, dizziness & somnolence may occur; may affect ability to drive or use machines. Adequate contraception in women w/ childbearing potential including those who are perimenopausal or who recently became postmenopausal is needed until their postmenopausal status is fully established. Not recommended for use in childn & adolescents ≤17 yr.
Plasma conc & exposure may be increased by strong CYP3A4 inhibitors including but not limited to ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin & telithromycin & CYP2A6 inhibitors (eg, methoxsalen). Plasma conc & exposure may be decreased by CYP3A4 inducers (eg, phenytoin, rifampicin, carbamazepine, phenobarb & St. John's Wort). Reduced plasma levels by tamoxifen. Caution when concomitantly used w/ medicinal products whose elimination is mainly dependent on CYP2A6 & CYP2C19 & whose therapeutic index is narrow (eg, phenytoin, clopidogrel).
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