Estrogen Receptor Antagonist

Indications: treatment of oestrogen-receptor-positive metastatic or locally advanced breast cancer in postmenopausal women in whom disease progresses or relapses while on, or after, other anti-oestrogen therapy Cautions: Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration.

Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment is recommended in patients with moderate impairment. Safety and efficacy have not been established in severe impairment.

Special handling:

Hazardous agent: Use appropriate precautions for handling and disposal.

Contra-indications: Hypersensitivity to fulvestrant or any component of the formulation.

Hepatic impairment: manufacturer advises caution in mild to moderate impairment (avoid in severe impairment).

Renal impairment: manufacturer advises caution if creatinine clearance less than 30 ml/minute—no information available.

Pregnancy: manufacturer advises avoid—increased incidence of fetal abnormalities and death in animal studies.

Breast-feeding: manufacturer advises avoid—present in milk in animal studies.

Side Effects: nausea, vomiting, diarrhoea; venous thromboembolism; anorexia, headache, asthenia; urinary- tract infections; hot flushes; back pain; rash, injection-site reactions, hypersensitivity reactions.

Less commonly: vaginal haemorrhage, vaginal candidiasis, and leucorrhoea.

Dose: By deep intramuscular injection into buttock, 500 mg every 2 weeks for the first 3 doses, then 500 mg every month.

Note: 500 mg dose should be administered as one 250-mg injection (slowly over 1–2 minutes) into each buttock Maintenance.