Method of use
- Intravenously, irrespective of food intake.
- The recommended dose of Letrozole Farmland is 2.5 mg (1 tablet) once daily, long-term.
- The patient should take the missed dose as soon as she remembers it. However, if it is the time to take the next dose, a double dose should not be taken as there is excessive systemic exposure if the daily dose of 2.5 mg is exceeded.
- In adjuvant therapy and extended adjuvant therapy, treatment with letrozole should be continued for 5 years or until relapse.
- In a large baseline study of letrozole compared with tamoxifen in adjuvant therapy, no efficacy or safety benefit was found with sequential use of these drugs compared with long-term use of letrozole for 5 years. In patients with metastatic disease, treatment with Farmland letrozole should be continued until signs of disease progression appear. In the setting of neoadjuvant (pre-operative) preparation to achieve optimal tumour size reduction, treatment with Letrozole Farmland should be continued for 4-8 months. In case of insufficient response, treatment with ‘Letrozole Farmland’ should be discontinued.
- No dose adjustment is required in elderly patients.
- No dose adjustment of letrozole is required in hepatic or renal insufficiency (creatinine clearance ≥10 ml/min). However, in cases of severe hepatic insufficiency (Child-Pugh severity grade C), patients should remain under constant medical supervision (see section “Pharmacological properties”).
- The use of letrozole is not recommended in children and adolescents under 18 years of age.