Ovalia Dosage/Direction for Use

Posology: Adult & elderly patients: The recommended dose of Letrozole tablet is 2.5 mg once daily.
In patients with advanced 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 neoadjuvant setting, treatment with letrozole tablets could be continued for 4 to 8 months in order to establish optimal tumour reduction. If the response is not adequate, treatment with letrozole tablets should be discontinued and surgery scheduled and/or further treatment options discussed with the patient.
Following standard adjuvant tamoxifen therapy, treatment with letrozole tablets should continue for 5 years or until tumour relapse occurs, whichever comes first. In patients with metastatic disease, treatment with letrozole tablets should continue until tumour progression is evident. Regular monitoring to observe progression during the pre-operative treatment period is recommended. No dose adjustment is required for elderly patients.
Paediatric population: Letrozole tablets is not recommended for use in children and adolescents. The safety and efficacy of letrozole tablets in children and adolescents aged up to 17 years have not been established. Limited data are available and no recommendation on a posology can be made.
Renal impairment: No dosage adjustment of letrozole tablets is required for patients with renal insufficiency with creatinine clearance ≥10 ml/min. Insufficient data are available in cases of renal insufficiency with creatinine clearance lower than 10 ml/min.
Hepatic impairment: No dosage adjustment of letrozole tablets is required for patients with mild to moderate hepatic insufficiency (Child-Pugh grade 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 tablets should be taken orally and can be taken with or without food.
A 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.