east Cancer, Median Treatment Duration of 60 Months 6.4 First-Line Treatment of Advanced Breast Cancer 6.5 Second- Line Treatment of Advanced Breast Cancer 6.6 First and Second-Line Treatment of Advanced Breast Cancer 6.7 Postmarketing Experience 7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES
14.1 Updated Adjuvant Treatment of Early Breast Cancer 14.2 Extended Adjuvant Treatment of Early Breast Cancer, Median Treatment Duration of 24 Months 14.3 Updated Analyses of Extended Adjuvant Treatment of Early Breast Cancer, Median Treatment Duration of 60 Months 14.4 First-Line Treatment of Advanced Breast Cancer 14.5 Second-Line Treatment of Advanced Breast Cancer 16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
1.1 Adjuvant Treatment of Early Breast CancerFemara (letrozole) is indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
1.2 Extended Adjuvant Treatment of Early Breast CancerFemara is 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 Femara in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with Femara for a median of 60 months [see Clinical Studies (14.2, 14.3)].
1.3 First and Second-Line Treatment of Advanced Breast CancerFemara is indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Femara is 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)].
2 DOSAGE AND ADMINISTRATION
2.1 Recommended DoseThe recommended dose of Femara is one 2.5 mg tablet administered once a day, without regard to meals.
2.2 Use in Adjuvant Treatment of Early Breast CancerIn the adjuvant setting, the optimal duration of treatment wit |
