Faslodex for the treatment of postmenopausal women with breast cancer who have

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Faslodex is indicated for the treatment of postmenopausal women of any age with locally advanced or metastatic breast cancer who have been previously treated with endocrine therapy, irrespective of whether their postmenopausal status occurred naturally or was artificially induced.

Dosage:

Adult females (including the elderly): The recommended dose is 250 mg to be administered intramuscularly slowly into the buttock at intervals of 1 month as either a single 5 mL injection or 2 concurrent 2.5 mL injections.

Patients with renal insufficiency: No dose adjustments are necessary for patients with a creatinine clearance greater than 30 mL /min.

Patients with hepatic insufficiency: No dose adjustments are necessary for patients with Child-Pugh category A and B hepatic impairment.

Contraindications: In patients with a known hypersensitivity to the drug substance or to any of the excipients

Warnings and precautions: Fulvestrant is metabolised primarily in the liver. Caution should be used with Faslodex in patients with creatinine clearance less than 30 mL/min. Caution should be used before treating patients with bleeding diatheses or thrombocytopenia or patients on anticoagulants due to the route of administration. Asthenia has been reported with Faslodex and caution should be observed by those patients who experience this symptom when driving or using machines.

Interactions: There are no known drug-drug interactions. Fulvestrant does not significantly inhibit any of the major cytochrome P450 (CYP) isoenzymes in vitro, and results from a clinical pharmacokinetic trial involving co-administration of fulvestrant with midazolam also suggest that therapeutic doses of fulvestrant will have no inhibitory effects on CYP3A4. Dosage adjustment is not necessary in patients co-prescribed CYP3A4 inhibitors or inducers.

Pregnancy and lactation: Animal studies have shown reproductive toxicity and distribution of fulvestrant to maternal milk. The potential risk for humans is unknown. Therefore use of Faslodex should be avoided in pregnant or lactating women.

Undesirable effects:

Very Common: injection site reactions,
Common: hot flushes, headache, asthenia, gastrointestinal disturbances including nausea, vomiting and diarrhoea, anorexia, elevated liver enzymes, rash, urinary tract infections.
Uncommon: hypersensitivity reactions including angioedema and urticaria.

Pharmacodynamic properties: Fulvestrant is an Estrogen Receptor Downregulator. It inhibits the growth of oestrogen-sensitive human breast cancer cells.

Further information is available on request from AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, or local AstraZeneca subsidiaries.

FASLODEX™ is a trademark of the AstraZeneca group. SafetyGlide™ is a trademark of Becton Dickinson and Company

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