Exemestane should not be administered to women with premenopausal endocrine status. Therefore, whenever clinically appropriate, the postmenopausal 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 a forbidden substance which is being able to provide a positive result in a doping control tests.
Exemestane is a potent oestrogen lowering agent, and a reduction in bone mineral density and an increased fracture rate has been observed following administration. During adjuvant treatment with Exemestane, women with osteoporosis or at risk of osteoporosis should treatment baseline bone mineral health assessment, based on current clinical guidelines and practice. Patients with advanced disease should have their bone mineral density (BMD) 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 tablets 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 (EBC). Women with Vitamin D deficiency should receive supplementation with Vitamin D.
Effects on ability to drive and use machines: Drowsiness, somnolence, asthenia and dizziness have been reported with the use of the drug. Patients should be advised that, if these events occur, their physical and/or mental abilities required for operating machinery or driving a car may be impaired.
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