Composition: Exemestane 25mg.
Presentation: Sugar-coated tablets.
Storage and stability: Do not store above 30C.
Action: Irreversible, steroidal aromatase inhibitor.
Indications: Treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti- oestrogen therapy. Third-line hormonal treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease progressed following treatment with anti-oestrogens and either non-steroidal aromatase inhibitors or progestins.
Contraindications: Premenopausal women and pregnant or lactating women. Patients with a known hypersensitivity to the drug or any of the excipients.
Dosage and administration: Adults and elderly, 25mg once daily, preferably after a meal. Continue until tumour progression is evident.
Children, not recommended.
Overdosage: No specific antidote to overdosage and treatment must be symptomatic. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
Precautions: Exemestane should not be co-administered with oestrogen-containing medicines as these would negate its pharmacological action.
Drug interactions: No formal drug interaction studies have been carried out. A possible decrease of exemestane plasma levels by known inducers of P450 (CYP) 3A4 cannot be excluded.
Side effects: In clinical studies, adverse events were usually mild to moderate. The most frequent, either drug related or of indeterminate cause, were hot flushes, nausea, fatigue, increased sweating and dizziness. Less common events, reported with an incidence higher than or equal to 2 per cent were headache, insomnia, pain, skin rash, abdominal pain, anorexia, vomiting, depression, alopecia, peripheral or leg oedema, constipation and dyspepsia.
Net price: 30 tablets £102.86.
Supplier: Pharmacia & Upjohn Ltd, Davy Avenue, Knowlhill, Milton Keynes MK5 8PH. Tel 01908 661101, fax 01908 690091.
Legal class: POM.