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Adjuvant Treatment of 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 in patients treated with Femara for a median of 60 months [see Clinical Studies].
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].
DOSAGE AND ADMINISTRATION
The recommended dose of Femara is one 2.5 mg tablet administered once a day, without regard to meals.
Use in Adjuvant Treatment of Early Breast Cancer
In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. The planned duration of treatment in the study was 5 years with 73% of the patients having completed adjuvant therapy. Treatment should be discontinued at relapse [see Clinical Studies].
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 was 60 months. Seventy-one percent of patients were treated for at least 3 years and 58% of patients completed least 4.5 years of extended adjuvant treatment. The treatment should be discontinued at tumor relapse [see Clinical Studies].
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]
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. The dose of Femara in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [see WARNINGS AND PRECAUTIONS]. The recommended dose of Femara for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on Femara exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined.
Use in Renal Impairment
No dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥ 10 mL/min. [see CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
2.5 mg tablets: dark yellow, film-coated, round, slightly biconvex, with beveled edges (imprinted with the letters FV on one side and CG on the other side).
Storage And Handling
Packaged in HDPE bottles with a safety screw cap.
2.5 milligram tablets
Bottles of 30 tablets..........................NDC 0078-0249-15
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Novartis Pharmaceuticals Corporation East Hanover, New Jersey, 07936. Revised: 12/2011
Last reviewed on RxList: 1/10/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Femara Information
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