Presentation and Status in Health Basket
30 X 25 mg
Adult and elderly patients: The recommended dose of Aromasin is one 25 mg tablet to be taken once daily, preferably after a meal.
In patients with early breast cancer, treatment with Aromasin should continue until completion of five years of adjuvant endocrine therapy, or until local or distant recurrence or new contralateral breast cancer.In patients with advanced breast cancer, treatment with Aromasin should continue until tumour progression is evident. No dose adjustments are required for patients with hepatic or renal insufficiency.
Children: Not recommended for use in children.
Aromasin is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2 – 3 years of initial adjuvant tamoxifen therapy.
Aromasin is indicated for the treatment of advanced breast cancer (ABC) in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy alone. Aromasin is also indicated for the treatment of postmenopausal women with ABC whose disease has progressed following multiple hormonal therapies.
Hypersensitivity to the active substance or to any of the excipients.
In pre-menopausal women and in pregnant or lactating women.
Aromasin 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.
Aromasin should be used with caution in patients with hepatic or renal impairment.
Aromasin tablets contain sucrose and should not be administered to patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Aromasin tablets contain methyl-para-hydroxybenzoate which may cause allergic reactions (possibly delayed).
Aromasin is a potent oestrogen lowering agent, and a reduction in bone mineral density (BMD) and an increased fracture rate have been observed following administration. At the commencement of adjuvant treatment with Aromasin, 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 Aromasin are not available, patients treated with Aromasin 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 associated in women with early breast cancer (EBC). Women with Vitamin D deficiency should receive supplementation with Vitamin D.
Aromasin was generally well tolerated across all clinical studies conducted with Aromasin at a standard dose of 25mg/day and undesirable effects were usually mild to moderate.
The withdrawal rate due to adverse events was 7.4% in patients with early breast cancer receiving adjuvant treatment with Aromasin following initial adjuvant tamoxifen therapy. The most commonly reported adverse reactions were hot flushes (22%), arthralgia (18%), and fatigue (16%).
The withdrawal rate due to adverse events was 2.8% in the overall patient population with advanced breast cancer. The most commonly reported adverse reactions were hot flushes (14%) and nausea (12%).
Most adverse reactions can be attributed to the normal pharmacological consequences of oestrogen deprivation (e.g., hot flushes).
See prescribing information for full details.
In vitro evidence showed that the drug is metabolised through cytochrome P450 CYP3A4 and aldoketoreductases (see section 5.2) and does not inhibit any of the major CYP isoenzymes. In a clinical pharmacokinetic study, the specific inhibition of CYP3A4 by ketoconazole showed no significant effects on the pharmacokinetics of exemestane.
In an interaction study with rifampicin, a potent CYP450 inducer, at a dose of 600 mg daily and a single dose of exemestane 25 mg, the AUC of exemestane was reduced by 54% and Cmax by 41%. Since the clinical relevance of this interaction has not been evaluated, the co-administration of medicinal products, such as rifampicin, anticonvulsants (e.g., phenytoin and
carbamazepine) and herbal preparations containing hypericum perforatum (St John’s Wort) known to induce CYP3A4 may reduce the efficacy of Aromasin.
Aromasinshould be used cautiously with medicinal productsthat are metabolised via CYP3A4 and have a narrow therapeutic window. There is no clinical experience of the concomitant use of Aromasinwith other anticancer medicines.
Aromasin should not be coadministered with oestrogen-containing medicines as these would negate its pharmacological action.
Pregnancy and Lactation
Pregnancy: No clinical data on exposed pregnancies are available with Aromasin. Studies on animals have shown reproductive toxicity. Aromasin is therefore contraindicated in pregnant women.
Lactaion: It is unknown whether exemestane is excreted in human milk. Aromasin should not be administered to lactating woman.
Clinical trials have been conducted with Aromasin given up to 800 mg in a single dose to healthy female volunteers and up to 600 mg daily to postmenopausal women with advanced breast cancer; these dosages were well tolerated. The single dose of Aromasin that could result in life-threatening symptoms is not known. In rats and dogs, lethality was observed after single oral doses equivalent respectively to 2000 and 4000 times the recommended human dose on a mg/m² basis. There is 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.
Storage: Store below 30°C.
Sodium content: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.