Recommended Dose: 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. The planned duration of treatment in the study was 5 years with 73% of the patients having completed adjuvant therapy.
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 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.
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, although Letrozole blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of Letrozole in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% (see Precautions). 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 ≥10 mL/min (see Pharmacology under Actions).