Exemestane
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Exemestane is indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1)].
Exemestane is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2)].
History
There is currently no drug history available for this drug.
Other Information
Exemestane Tablets for oral administration contain 25 mg of exemestane, an irreversible, steroidal aromatase inactivator. Exemestane is chemically described as 6-methylenandrosta-1,4-diene-3,17-dione. Its molecular formula is C20H24O2 and its structural formula is as follows:
The active ingredient is a white to slightly yellow powder with a molecular weight of 296.41. Exemestane is freely soluble in tetrahydrofuran and dimethylformamide; soluble in acetone, acetonitrile, methanol, and ethyl acetate; sparingly soluble in ethanol; very slightly soluble in nhexane and insoluble in water.
Each Exemestane Tablet contains the following inactive ingredients: mannitol, copovidone, crospovidone, silicified microcrystalline cellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol 400, and hypromellose.
Sources
Exemestane Manufacturers
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American Health Packaging
![Exemestane Tablet [American Health Packaging]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Exemestane | American Health Packaging
2.1 Recommended DoseThe recommended dose of exemestane in early and advanced breast cancer is one 25 mg tablet to be taken once daily after a meal.
• adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy. • the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. 2.2 Dose ModificationsConcomitant use of strong CYP 3A4 inducers decreases exemestane exposure. For patients receiving exemestane with a strong CYP 3A4 inducer such as rifampicin or phenytoin, the recommended dose of exemestane is 50 mg once daily after a meal [see Drug Interactions (7) and Clinical Pharmacology (12.3)].
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Greenstone Llc
Exemestane | Greenstone Llc
2.1 Recommended DoseThe recommended dose of EXEMESTANE in early and advanced breast cancer is one 25 mg tablet once daily after a meal.
adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy . the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. 2.2 Dose ModificationsFor patients receiving EXEMESTANE with a potent CYP 3A4 inducer such as rifampicin or phenytoin, the recommended dose of EXEMESTANE is 50 mg once daily after a meal.
The safety of chronic dosing in patients with moderate or severe hepatic or renal impairment has not been studied. Based on experience with EXEMESTANE at repeated doses up to 200 mg daily that demonstrated a moderate increase in non life-threatening adverse events, dosage adjustment does not appear to be necessary [see Use In Specific Populations (8.6 and 8.7)].
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Alvogen Inc.
Exemestane | Alvogen Inc.
2.1 Recommended DoseThe recommended dose of exemestane in early and advanced breast cancer is one 25 mg tablet to be taken once daily after a meal.
2.2 Dose Modifications
• adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy.
• the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure. For patients receiving exemestane with a strong CYP 3A4 inducer such as rifampicin or phenytoin, the recommended dose of exemestane is 50 mg once daily after a meal [see Drug Interactions(7)and Clinical Pharmacology(12.3)].
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Roxane Laboratories, Inc
Exemestane | Roxane Laboratories, Inc
2.1 Recommended DoseThe recommended dose of exemestane tablets in early and advanced breast cancer is one 25 mg tablet once daily after a meal.
• adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy . • the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. 2.2 Dose ModificationsConcomitant use of strong CYP 3A4 inducers decreases exemestane exposure. For patients receiving exemestane with a strong CYP 3A4 inducer such as rifampicin or phenytoin, the recommended dose of exemestane is 50 mg once daily after a meal [see Drug Interactions (7) and Clinical Pharmacology (12.3)].
![Exemestane Tablet, Sugar Coated [Greenstone Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=69abd0ff-b200-4d1a-b14a-80e980a8e781&name=exemestane-05.jpg)
![Exemestane Tablet [Alvogen Inc. ]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Exemestane Tablet, Film Coated [Roxane Laboratories, Inc]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
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