Posology: Adult and elderly patients: The recommended dose of Letrozole tablets is 2.5 once daily. No dose adjustment is required for elderly patients.
In patients with advance or metastatic breast cancer, treatment with Letrozole Tablets should continue until tumour progression is evident.
In the adjuvant and extended adjuvant setting, treatment with Letrozole Tablets should continue for 5 years or until tumour relapse occurs whichever is first.
In the adjuvant setting, a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered.
In the neoadjuvant setting, treatment with Letrozole tablet could be continued for 4 to 8 months in order to establish optimal tumour reduction. If the response is not adequate, treatment with Letrozole tablet should be discontinued and surgery scheduled and/or further treatment options discussed with the patient.
Paediatric population: Letrozole tablet is not recommended for use in children and adolescence. The safety and efficacy of Letrozole tablet in children and adolescence age up to 17 years have not been established. Limited data are available and no recommendation posology can be made.
Renal Impairment: No dosage adjustment of Letrozole tablet is required for patients with renal insufficiency with creatinine clearance ≥10ml/min. Insufficient data are available in cases of renal insufficiency with creatinine clearance lower than 10 ml/min.
Hepatic impairment: No dose adjustment of Letrozole tablet is required for patients with mild to moderate hepatic and sufficiency (Child-Pugh A or B). Insufficient data are available for patients with severe hepatic impairment. Patients with severe hepatic impairment (Child-Pugh C) require close supervision.
Method of administration: Letrozole tablet should be taken orally and can be taken with or without food.
The missed dose should be taken as soon as the patient remembers. However, if it is almost time for the next dose (within 2 or 3 hours), the missed dose should be skipped, and the patient should go back to her regular dosage schedule. Doses should not be doubled because with daily doses over the 2.5 mg recommended dose, over proportionality in systemic exposure was observed.
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