Letrozole Mevon Tablets 2.5mg

TABLET, FILM COATED

**4.2 Posology and method of administration** Adults and elderly patients The recommended dose of Letrozole is 2.5 mg once daily. 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. 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 tumour relapse. In patients with metastatic disease, treatment with Letrozole should continue until tumour progression is evident. No dose adjustment is required for elderly patients. 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. Children Not applicable. Patients with hepatic and/or renal impairment No dosage adjustment is required for patients with hepatic impairment or renal impairment (creatinine clearance ≥10 mL/min.). However, the dose of Letrozole in patients with cirrhosis and severe hepatic dysfunction (Child-Pugh score C) should be reduced by 50% (see PHARMACOKINETICS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The recommended dose of letrozole for such patients is 2.5mg administered every other day. Patients with severe hepatic impairment should be kept under close supervision (see section PHARMACOKINETICS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).