Femara (Letrozole) - Indications and Dosage

INDICATIONS AND USAGE

Femara^® (letrozole tablets) is indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer (see CLINICAL STUDIES). 

The effectiveness of Femara in early breast cancer is based on an analysis of disease-free survival in patients treated for a median of 24 months and followed for a median of 26 months (see CLINICAL STUDIES). Follow up analyses will determine long-term outcomes for both safety and efficacy.

Femara is indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy (see CLINICAL STUDIES). The effectiveness of Femara in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated for a median of 24 months (see CLINICAL STUDIES). Further data will be required to determine long-term outcome.

Femara is indicated for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor 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.

DOSAGE AND ADMINISTRATION

Adult and Elderly Patients

The recommended dose of Femara^® (letrozole tablets) is one 2.5 mg tablet administered once a day, without regard to meals. In patients with advanced disease, treatment with Femara should continue until tumor progression is evident.

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. However, at the time of the analysis, the median treatment duration was 24 months, 25% of patients were treated for at least 3 years and less than 1% of patients were treated for the planned duration of 5 years. The median duration of follow-up was 28 months. Treatment should be discontinued at tumor relapse (see CLINICAL STUDIES).

In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. The planned duration of treatment in the study is 5 years. However, at the time of analysis, the median duration of treatment was 24 months, median duration of follow-up was 26 months, and 16% of the patients have been treated for 5 years. Treatment should be discontinued at relapse (see CLINICAL STUDIES).

No dose adjustment is required for elderly patients. Patients treated with Femara do not require glucocorticoid or mineralocorticoid replacement therapy.

Renal Impairment

(See CLINICAL PHARMACOLOGY.) No dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥10 mL/min.

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 CLINICAL PHARMACOLOGY). 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. (See CLINICAL PHARMACOLOGY.)

HOW SUPPLIED

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).

Packaged in HDPE bottles with a safety screw cap.

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].

REV: SEPTEMBER 2008                                              T2008-92

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936