Adult and Elderly Patients: The recommended dose of Letrozole tablet is one 2.5 mg tablet administered once a day, without regard to meals. In patients with advanced disease, treatment with Letrozole tablet should continue until tumor progression is evident.
In the extended adjuvant setting, the optimal treatment duration with Letrozole tablet 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.
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 had been treated for 5 years. Treatment should be discontinued at relapse.
Renal Impairment: No dosage adjustment is required for patients with renal impairment if creatinine clearance is 10 mL/min.
Hepatic Treatment: No dosage adjustment is recommended for patients with mild to moderate hepatic impairment, although blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of Letrozole tablet in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50%. The recommended dose of Letrozole tablet for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined.
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