AROMASIN
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Package:
TABLETS: 30.
Dosage:
1 tablet (25 mg) once daily, preferably after a meal.
Advanced breast cancer: Continue treatment until tumor progression is evident.
Early breast cancer: Continue treatment until completion of five years of adjuvant hormonal therapy, or until tumor relapse occurs.
Prescribing Restrictions:
Indications:
Advanced breast cancer (ABC) in women with natural/induced post-menopausal status (progressed following anti-estrogen therapy alone) and in post-menopausal women (progressed following multiple hormonal therapies).
For the adjuvant treatment of postmenopausal women with estrogen receptor positive invasive early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy.
Contra-Indications:
Patients with a known hypersensitivity to the active substance or to any of the excipients and in pre-menopausal women. Pregnancy and lactation.
Special Precautions:
Women with pre-menopausal endocrine status. Patients with hepatic or renal impairment. Should not be co-administered with estrogen-containing medicines. Should be used cautiously with drugs that are metabolized via CYP3A4 and have a narrow therapeutic window. Patients should be advised that the physical and/or mental abilities required for operating machinery or driving a car may be impaired. As exemestane is a potent estrogen lowering agent, reductions in bone mineral density can be anticipated. During adjuvant treatment, women with osteoporosis or at risk of osteoporosis should have their bone mineral density formally assessed at the commencement of treatment and at regular intervals thereafter. Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored.
Side Effects:
Hot flushes, nausea, fatigue, increased sweating and dizziness. Other less common undesirable effects include headache, insomnia, pain, rash, abdominal pain, anorexia, vomiting, depression, alopecia, peripheral or leg edema, constipation and dyspepsia. Joint and musculoskeletal pain, osteoporosis, fracture.
Drug Interactions:
See prescribing information for full details.
