Letrovitae Dosage/Direction for Use

Adult and elderly patients: The recommended dose of letrozole is 2.5 mg once daily. No dose adjustment is required in elderly patients.
In patients with advanced or metastatic breast cancer, treatment with letrozole should continue until the progression of the tumor is evident.
In the adjuvant and extended adjuvant setting, treatment with letrozole should continue for 5 years or until tumour relapse occurs, whichever comes first.
In adjuvant setting, a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered (see Precautions and PHARMACOLOGY: Pharmacodynamics under Actions).
In neoadjuvant setting, treatment with letrozole could be continued for 4 to 8 months in order to establish optimal tumor reduction. If the response is not adequate, treatment with LETROVITAE should be discontinued and surgery scheduled and/or further treatment options discussed with the patient.
Paediatric population: Letrozole is not recommended for use in children and adolescents. The safety and efficacy of letrozole in children and adolescents aged up to 17 years have not been established. Limited data are available and recommendation on a posology can be made.
Renal impairment: No dose adjustment of letrozole is required for patients with renal insufficiency with creatinine clearance ≥10 ml/min. Insufficient data are available in cases of renal insufficiency with a creatinine clearance lower than 10 ml/min (see Precautions and PHARMACOLOGY: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment of letrozole is required for patients with mild to moderate hepatic impairment (Child-Pugh A or B). Insufficient data are available for patients with severe hepatic impairment. Patients with severe hepatic impairment (Child-Pugh C) required close supervision (see Precautions and PHARMACOLOGY: Pharmacokinetics under Actions).
Method of administration: LETROVITAE 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 (see PHARMACOLOGY: Pharmacokinetics under Actions).