fulvestrant: clinical use

Prescribing considerations

• Confirm receptor and menopausal status, previous endocrine therapy, and whether use matches the licensed setting.
• Consider thromboembolic risk, bleeding tendency, platelet count, anticoagulant use, hepatic or renal impairment, and osteoporosis risk.
• Critical visceral disease was not studied in the supporting evidence.

Contraindications and cautions

• Hypersensitivity to fulvestrant or an excipient
• Pregnancy
• Breastfeeding
• Severe hepatic impairment

Monitoring

• Assess liver function and investigate significant hepatic symptoms or biochemical abnormalities.
• Monitor for injection-site reactions, sciatic-nerve symptoms, bleeding, thromboembolism and hypersensitivity.
• Consider bone health where osteoporosis risk is relevant; long-term bone-effect data are unavailable.
• Interpret antibody-based estradiol assays cautiously because results may be falsely increased.

Clinical pharmacology

A competitive oestrogen-receptor antagonist that downregulates receptor protein without partial agonist activity. It is highly protein-bound, predominantly metabolised and excreted in faeces; non-CYP pathways predominate in vivo.

Formulation and product differences

• The selected product is a clear, colourless-to-yellow viscous solution in single-use glass pre-filled syringes with safety needles.
• It contains ethanol, benzyl alcohol, benzyl benzoate and refined castor oil; these excipients may be relevant to hypersensitivity and hepatic or renal impairment.
• No special storage temperature is required, but it should remain in its original packaging to protect it from light.

Injection

Route: Parenteral

Strengths: 250 mg