| Indications1 |
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| Aromasin® is indicated for the adjuvant treatment of postmenopausal women with estrogen-receptor (ER)-positive invasive early breast cancer, following 2–3 years of initial adjuvant tamoxifen therapy; and for the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-estrogen therapy. |
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| Clinical Evidence |
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- Patients switched to exemestane after 2–3 years on tamoxifen showed early improvements in disease-free survival, which persisted after treatment and translated into a modest improvement in overall survival2
- Switch to exemestane significantly improved efficacy versus continued tamoxifen in the ER-positive/unknown population2
Improvement in disease-free survival
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E, exemestane; T, tamoxifen; HR, hazard ratio; CI, confidence interval
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- Long-term effects of sequential therapy (ie, tamoxifen followed by exemestane) did not significantly differ from that of exemestane monotherapy, resulting in a 5-year overall survival of 91% 3
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| Safety Profile1 |
ADVERSE REACTIONS: Insomnia, headache, hot flushes, nausea, increased sweating; joint and musculoskeletal pain, fatigue; anorexia, depression, dizziness, carpal tunnel syndrome, abdominal pain, vomiting, constipation, dyspepsia, diarrhea, rash, alopecia, osteoporosis, fracture, pain, peripheral edema
INTERACTIONS: Co-medications that induce cytochrome P450 3A4 (CYP3A4) enzyme (eg, rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort) may significantly decrease exposure to exemestane
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| Dosages1 |
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| Adults and elderly: 1 tablet od |
| Early breast cancer: Continue therapy until completion of 5 years of combined sequential adjuvant hormonal therapy or earlier if tumor relapse occurs. |
| Advanced breast cancer: Continue until tumor progression is evident. |
| Strengths1 |
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| 25 mg. |
| Packing1 |
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| Tablet: 25 mg x 30's. |
| Important Safety Information1 |
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| CONTRAINDICATIONS: Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency; pregnancy and lactation |
| SPECIAL PRECAUTIONS: Hepatic or renal impairment; osteoporosis |
| ADVERSE REACTIONS: Insomnia, headache, hot flushes, nausea, increased sweating; joint and musculoskeletal pain, fatigue; anorexia, depression, dizziness, carpal tunnel syndrome, abdominal pain, vomiting, constipation, dyspepsia, diarrhea, rash, alopecia, osteoporosis, fracture, pain, peripheral edema |
| PREGNANCY and LACTATION: Aromasin® is contraindicated in pregnant women and should not be administered to lactating women. The physician needs to discuss the necessity of adequate contraception with women who have the potential to become pregnant including perimenopausal women or those who have recently become postmenopausal (until their postmenopausal status is fully established). |
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Please refer to the full prescribing information for more safety information |
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| References |
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1. Aromasin® (exemestane) Prescribing Information. Pfizer Corporation Hong Kong Ltd: 22 May 2009.
2. Coombes RC, Kilburn LS, Snowdon CF, et al. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): A randomised controlled trial. Lancet. 2007;369(9561):559-570.
3. van de Velde CJH, Rea D, Seynaeve C, et al. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): A randomised phase 3 trial. Lancet. 2011;377(9762):321-331.
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Please review the full product information or package insert before prescribing. |
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ARO11005P |
