Package:
PRE-FILLED SYRINGE (with plunger rod and safety needle): 2
Dosage:
Adult females, including the elderly: Should be administered as two consecutive 5 ml injections by slow I.M. injection, one in each buttock. The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose.
Children and adolescents: Not recommended, as safety and efficacy have not been established in these groups.
Renal impairment: No dose adjustment recommended in mild to moderate renal impairment (creatinine clearance > 30 ml/min). Safety and efficacy have not been evaluated in severe renal impairment (creatinine clearance <30 ml/min).
Hepatic impairment: Use with caution in mild-moderate hepatic impairment. Safety and efficacy have not been evaluated in patients with hepatic impairment. Prescribing Restrictions:
Indications:
Treatment of postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-estrogen therapy or disease progression on therapy with an anti-estrogen.
Contra-Indications:
Known hypersensitivity to the active substance or any of the excipients. Pregnancy and lactation. Severe hepatic impairment.
Special Precautions:
See prescribing information for full details.
Side Effects:
See prescribing information for full details.
Drug Interactions:
See prescribing information for full details.
