exemestane 25 MG Oral Tablet

1 INDICATIONS AND USAGE Exemestane tablets are an aromatase inhibitor 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 tablets for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). • treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). 1.1 Adjuvant Treatment of Postmenopausal Women Exemestane tablets are 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 tablets for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1) ] . 1.2 Advanced Breast Cancer in Postmenopausal Women Exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2) ].

Mylan Pharmaceuticals Inc.

FDA Reported Adverse Reactions
`[1] diarrhoea` `[2] nausea` `[3] off label use` `[4] vomiting` `[5] dyspnoea` `[6] drug ineffective` `[7] death` `[8] pyrexia` `[9] fatigue` `[10] acute kidney injury`

4 years ago

ROUND WHITE X M

16 HOW SUPPLIED/STORAGE AND HANDLING Exemestane Tablets are available containing 25 mg of exemestane, USP. The 25 mg tablets are white, film-coated, round, unscored tablets debossed with X on one side of the tablet and M on the other side. They are available as follows: NDC 0378-5001-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

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exemestane 25 MG Oral Tablet

FDA Reported Adverse Reactions [1] diarrhoea [2] nausea [3] off label use [4] vomiting [5] dyspnoea [6] drug ineffective [7] death [8] pyrexia [9] fatigue [10] acute kidney injury

ROUND WHITE X M

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FDA Reported Adverse Reactions
`[1] diarrhoea` `[2] nausea` `[3] off label use` `[4] vomiting` `[5] dyspnoea` `[6] drug ineffective` `[7] death` `[8] pyrexia` `[9] fatigue` `[10] acute kidney injury`