COMPOSITION
Each Tablet Contains: Exemestane 25 mg
PHARMACOLOGICAL CLASSIFICATION
Anti-neoplastic agent.
PHARMACOLOGICALACTION
Exemestane is an irreversible, hormone aromatase inhibitor, structurally related to the natural substrate androstenedione. In post-menopausal women, estrogens are produced primarily from the conversion of androgens into estrogens through the aromatase enzyme in peripheral tissues. Estrogen deprivation through aromatase inhibition is an effective and selective treatment for hormone dependent breast cancer in postmenopausal women.
INDICATIONS
Exemestane is indicated for the adjuvant treatment of postmenopausal women with estrogen receptor positive invasive early breast cancer (EBC), 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 status whose disease has progressed following anti-estrogen therapy. Efficacy has not been demonstrated in patients with estrogen receptor negative status.
WARNINGS
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 estradiol levels. Exemestane should be used with caution in patients with hepatic or renal impairment.
DOSAGE AND DIRECTIONS FOR USE
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 tumor relapse occurs. In patients with advanced breast cancer, treatment with Exemestane should continue until tumor progression is evident. No dose adjustments are required for patients with hepatic or renal insufficiency. Pediatric population Not recommended for use in children.
SIDE-EFFECTS AND SPECIALPRECAUTIONS
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. The withdrawal rate due to adverse events was 7.4% 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%). 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 estrogen deprivation (e.g., hot flushes).
KNOWN SYMPTOMS OFOVERDOSAGE AND PARTICULARS OFITS TREATMENT
See “Side-effects and Special Precautions”. Treat symptomatically.
How Supplied
Exemestane is supplied 5x10 tablets blister packed in carton along with package insert. Tablets should be stored at controlled room temperatures below 30°C and protected from light. If it has expired or is damaged, return it to your pharmacist for disposal.
KEEP OUT OF REACH OF CHILDREN
Manufactured by : COOPER PHARMALIMITED
