letrozole 2.5 MG Oral Tablet
1 INDICATIONS AND USAGE Letrozole tablets are an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer ( 1.1 ) Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy ( 1.2 ) First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer ( 1.3 ) 1.1 Adjuvant Treatment of Early Breast Cancer Letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. 1.2 Extended Adjuvant Treatment of Early Breast Cancer Letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [ see Clinical Studies ( 14.2 , 14.3 ) ]. 1.3 First and Second-Line Treatment of Advanced Breast Cancer Letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see Clinical Studies ( 14.4 , 14.5 )] .
Teva Pharmaceuticals USA, Inc.
ROUND YELLOW TEVA B1
TEVA B1 ROUND YELLOW
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letrozole 2.5 MG Oral Tablet
Teva Pharmaceuticals USA, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
LETROZOLE tablets USP, 2.5 mg are available as follows: 2.5 mg – dark-yellow, standard convex round, unscored, film-coated tablets, debossed with “TEVA” on one side and “B1” on the other side of the tablet, in bottles of 30 (NDC 0093-7620-56). 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, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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