Monotherapy for treatment of estrogen receptor +ve, locally advanced or metastatic breast cancer in postmenopausal women not previously treated w/ endocrine therapy, or w/ disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. In combination w/ palbociclib for treatment of hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.
Adult female (including elderly) 500 mg at 1 mth interval, w/ an additional 500 mg given 2 wk after initial dose. Administer as 2 consecutive 5 mL inj by slow IM (1-2 min/inj), 1 in each buttock (gluteal area).
Caution should be taken when injecting at the dorsogluteal site due to proximity of the underlying sciatic nerve. Reports of inj site related events including sciatica, neuralgia, neuropathic pain & peripheral neuropathy. Possible thromboembolic events in women w/ advanced breast cancer. Potential risk of osteoporosis. May interfere w/ Ab based-estradiol assay; may result in falsely increased estradiol levels. Contains ethanol & benzyl alcohol. Reports of asthenia which may affect ability to drive & use machines. Caution in patients w/ bleeding diatheses, thrombocytopenia or those taking anticoagulants; mild to moderate hepatic impairment & severe renal impairment (CrCl <30 mL/min). Women of childbearing potential should use effective contraception during treatment & for 2 yr after the last dose. Safety & efficacy have not been established in childn ≤18 yr & in patients w/ critical visceral disease.
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