For the treatment of postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant antioestrogen therapy or disease progression on therapy with an antioestrogen.

Fulvestrant is an estrogen receptor antagonist and binds to estrogen receptors on tumors and other tissue targets, producing a nuclear complex that causes a dose-related down-regulation of estrogen receptors and inhibits tumor growth.

Fulvestrant is slowly absorbed and MAX plasma concentrations are reached after about 7 days. Metabolism: Hepatic: via CYP3A4 pathway. Steady-state levels are reached after about 6 doses during monthly injections with the major part of the accumulation achieved after 3-4 doses. The terminal half-life is governed by the absorption rate and was estimated to be 50 days.

Hypersensitivity to Fulvestrant or to any of the excipients; pregnancy and in breast-feeding; severe hepatic impairment

D

not recommended

The most commonly reported adverse reactions are hot flushes, nausea, vomiting and injection site reactions; others including abdominal pain, diarrhea, constipation, headache and backache.

250 mg IM once monthly, administer slowly in buttocks

Store in the original container at 2 to 8℃