Letrozole Tablets 2.5 mg, 30

INDICATIONS

Adjuvant Treatment of Early Breast Cancer: It is indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.

Extended Adjuvant Treatment of Early Breast Cancer: It 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 Letrozole in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with Letrozole for a median of 60 months.

First and Second-Line Treatment of Advanced Breast Cancer: It is indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

DOSAGE AND ADMINISTRATION

The recommended dose of Letrozole 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. In both the adjuvant study and the post approval adjuvant study, median treatment duration was 5 years. Treatment should be discontinued at relapse.

Use in Extended Adjuvant Treatment of Early Breast Cancer: In the extended adjuvant setting, the optimal treatment duration with Letrozole 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 Letrozole was 60 months. Seventy-one (71%) percent of patients were treated for at least 3 years and 58% of patients completed at least 4.5 years of extended adjuvant treatment. The treatment should be discontinued at tumor relapse.

Use in First and Second-Line Treatment of Advanced Breast Cancer: In patients with advanced disease, treatment with Letrozole should continue until tumor progression is evident.

Use in Hepatic Impairment: No dosage adjustment is recommended for patients with mild to moderate hepatic impairment. The dose of Letrozole in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50%. The recommended dose of Letrozole for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on Letrozole 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 greater than or equal to 10 ml/min.

Or, as directed by the registered physician.

Use in Pregnancy:

Pregnancy Category D.

Letrozole can cause fetal harm and is contraindicated for use in women.

Use in Lactation:

It is not known if Letrozole is present in human milk. Because of the potential for serious adverse reactions in breastfed infants from Letrozole, lactating women should be advised not to breastfeed while taking Letrozole and for at least 3 weeks after the last dose.

Packing: Letrozol: Each box contains 10 tablets in Alu-Alu blister pack.