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EXEMESTANE is a brand name for Exemestane. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Exemestane 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. Exemestane is indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal…
Verbatim from this product's MHRA label. Tap a section to expand.
Adult and elderly patients The recommended dose of Exemestane is one film-coated tablet (25mg) to be taken orally once a day, 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). Children and adolescents Not recommended for use in children and adolescents
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%).
g. hot flushes). The reported adverse reactions 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 (≥1/1000 to < 1/100), rare (≥1/10,000 to <1/1000); Not known (cannot be estimated from the available data).
System organ class Very common (≥1/10) Common (≥1/100 to <1/10) Uncommo n (≥1/1000 to <1/100) Rare (≥1/10,00 0 to <1/1000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Metabolism and nutrition disorders Anorexia Psychiatric disorders Insomnia Depression Nervous system disorders Headache Dizziness, carpal tunnel syndrome, paraesthesia Somnolenc e Vascular disorders Hot flushes Gastrointestin al disorders Nausea Abdominal pain, vomiting, constipation , dyspepsia, diarrhoea Skin and subcutaneous tissue disorders Increased sweating Rash, alopecia, urticaria, pruritis (†) Acute generalised exanthemat ous pustulosis Immune system disorders Hypersensi tivity Musculoskele tal and bone disorders Joint and musculoskeletal pain (*) Osteoporosi s, fracture General disorders and administration site conditions Fatigue Pain, peripheral oedema Asthenia Blood and lymphatic system disorders: Leucopenia (**) Thrombo cytopenia (**) Lymphocyte count decreased (**) Hepatobiliary disorders Hepatitis (†) , cholestatic hepatitis (†) hepatic enzyme increased (†) , blood bilirubin increased (†) , blood alkaline phosphatas e increased (†) (*) Includes: arthralgia, and less frequently pain in limb, osteoarthritis, back pain, arthritis, myalgia and joint stiffness (**) In patients with advanced breast cancer thrombocytopenia and leucopenia have been rarely reported.
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.
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 (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 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.
Exemestane is contraindicated in: - premenopausal women. - women who are pregnant or breastfeeding - patients with hypersensitivity to the active substance or to any of the excipients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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An occasional decrease in lymphocytes has been observed in approximately 20% of patients receiving Exemestane, particularly in patients with pre-existing lymphopenia; however, mean lymphocyte values in these patients did not change significantly over time and no corresponding increase in viral infections was observed.
These effects have not been observed in patients treated in early breast cancer studies. (†) Frequency calculated by rule of 3/X The table below presents the frequency of pre-specified adverse events and illnesses in the early breast cancer study (IES), irrespective of causality, reported in patients receiving trial therapy and up to 30 days after cessation of trial therapy.
2%, respectively. 7%). 7% vs. 1%). In a separate double blinded, randomized study of postmenopausal women with early breast cancer at low risk treated with exemestane (N=73) or placebo (N=73) for 24 months, exemestane was associated with an average 7-9% mean reduction in plasma HDL-cholesterol, versus a 1% increase on placebo.
There was also a 5-6% reduction in apolipoprotein A1 in the exemestane group versus 0-2% for placebo. The effect on the other lipid parameters analysed (total cholesterol, LDL cholesterol, triglycerides, apolipoprotein-B and lipoprotein-a) was very similar in the two treatment groups.
The clinical significance of these results is unclear. 1%). The majority of patients on exemestane with gastric ulcer received concomitant treatment with non-steroidal anti-inflammatory agents and/or had a prior history.
Adverse reactions from post-marketing experience Hepatobiliary disorders:
Hepatitis, cholestatic hepatitis Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow card in Google Play or Apple App Store.