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Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions Adverse Reactions/Side Effects Drug Interactions Use In Specific Populations Overdosage Description Clinical Pharmacology Nonclinical Toxicology Clinical Studies How Supplied/Storage and Handling Patient Counseling Information. Adjuvant Treatment of Early Breast Cancer. Femara (letrozole) is indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Extended Adjuvant Treatment of Early Breast Cancer. Femara 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 (DFS) in patients treated with Femara for a median of 60 months [see Clinical Studies (14. First and Second-Line Treatment of Advanced Breast Cancer. Femara 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. The recommended dose of Femara is one 2. Use in Adjuvant Treatment of Early Breast Cancer. In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. In both the adjuvant study and the post approval adjuvant study, median treatment duration was 5 years. Treatment should be discontinued at relapse [ see Clinical Studies (14. Use in Extended Adjuvant Treatment of Early Breast Cancer. In the extended adjuvant setting, the optimal treatment duration with Femara is not known. The planned duration of treatment in the study was 5 years. In the final updated analysis, conducted at a median follow-up of 62 months, the median treatment duration for Femara was 60 months. Seventy-one percent (71%) of patients were treated for at least 3 years and 58% of patients completed at least 4. The treatment should be discontinued at tumor relapse [see Clinical Studies (14. Use in First and Second-Line Treatment of Advanced Breast Cancer. In patients with advanced disease, treatment with Femara should continue until tumor progression is evident [see Clinical Studies (14. Use in Hepatic Impairment. No dosage adjustment is recommended for patients with mild to moderate hepatic impairment, although Femara blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis, nido one plus egypt. The dose of Femara in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [see Warnings and Precautions (5.
Plasma concentrations at steady state are approximately 7 times higher than concentrations measured after a single dose of 2, nido one plus egypt.
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