EXEMESTANE

Posology Adult and elderly patients The recommended dose of Exemestane is one 25 mg tablet to be taken once daily preferably after a meal. In patients with early breast cancer, treatment with Exemestane should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by Exemestane), or earlier if tumour relapse occurs.

In patients with advanced breast cancer, treatment with Exemestane should continue until tumour progression is evident. 2). Paediatric population Not recommended for use in children.

Exemestane was generally well tolerated across all clinical studies conducted with Exemestane at a standard dose of 25 mg/day, and undesirable effects were usually mild to moderate. 4% in patients with early breast cancer receiving adjuvant treatment with Exemestane following initial adjuvant tamoxifen therapy.

The most commonly reported adverse reactions were hot flushes (22%), arthralgia (18%) and fatigue (16%). 8% in the overall patient population with advanced breast cancer. The most commonly reported adverse reactions were hot flushes (14%) and nausea (12%).

, hot flushes). The reported adverse reactions from clinical studies and post-marketing experience are listed below by system organ class and by frequency.

Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

Blood and lymphatic system disorders:

Very common Leucopenia(**) Common Thrombocytopenia(**) Not known Lymphocyte count decreased(**) Immune system disorders: Uncommo n Hypersensitivity Metabolism and nutrition disorders: Common Anorexia Psychiatric disorders: Very common Depression, insomnia Nervous system disorders: Very common Headache, dizziness Common Carpal tunnel syndrome, paraesthesia Rare Somnolence Vascular disorders: Very common Hot flushes Gastrointestinal disorders: Very common Abdominal pain, nausea Common Vomiting, diarrhoea, constipation, dyspepsia, Hepatobiliary disorders: Rare Hepatitis,(†) cholestatic hepatitis(†) Skin and subcutaneous tissue disorders: Very common Hyperhidrosis Common Alopecia, rash, urticaria, pruritus Rare Acute generalised exanthematous pustulosis(†) Musculoskeletal and connective tissue disorders: Very common Joint and musculoskeletal pain(*) Common Fracture, osteoporosis General disorders and administration site conditions: Very common Pain, fatigue Common Oedema peripheral, asthenia Investigations: Very common Hepatic enzyme increased, blood bilirubin increased, blood alkaline phosphatase increased (*) Includes: arthralgia, and less frequently pain in extremity, osteoarthritis, back pain, arthritis, myalgia and joint stiffness.

Exemestane should not be administered to women with pre-menopausal endocrine status. Therefore, whenever clinically appropriate, the post- menopausal status should be ascertained by assessment of LH, FSH and oestradiol levels. Exemestane should be used with caution in patients with hepatic or renal impairment.

Exemestane tablets contain sucrose and should not be administered to patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Exemestane tablets contain methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

1). At the commencement of adjuvant treatment with Exemestane, women with osteoporosis or at risk of osteoporosis should have treatment baseline bone mineral health assessment based on current clinical guidelines and practice. Patients with advanced disease should have their bone mineral density assessed on a case-by-case basis.

Although adequate data to show the effects of therapy in the treatment of the bone mineral density loss caused by Exemestane are not available, patients treated with Exemestane should be carefully monitored and treatment for, or prophylaxis of, osteoporosis should be initiated in at risk patients.

Routine assessment of 25 hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be considered, due to the high prevalence of severe deficiency in women with early breast cancer. Women with Vitamin D deficiency should receive supplementation with Vitamin D.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. In pre-menopausal women and in pregnant or lactating women.