Femara Dosage/Direction for Use

Dosage: General target population: Adults: The recommended dose of Femara is 2.5 mg once daily. In the adjuvant and extended adjuvant setting, treatment with Femara should continue for 5 years or until disease relapse/recurrence occurs, whichever comes first. In the large pivotal study of letrozole versus tamoxifen in the adjuvant setting, no benefit in efficacy or safety was obtained by sequential administration of these treatments compared with letrozole administered continuously for 5 years. In patients with metastatic disease, treatment with Femara should continue until tumor progression is evident. In the pre-operative setting, treatment with Femara should be continued for 4 to 8 months in order to establish optimal tumor reduction. If the response is not adequate, treatment with Femara should be discontinued, surgery scheduled and/or further treatment options discussed with the patient.
Special populations: Hepatic impairment: No dose adjustment of Femara is required for patients with mild to moderate hepatic insufficiency (Child-Pugh score A or B). Insufficient data are available for patients with severe hepatic impairment, but patients with severe hepatic impairment (Child-Pugh score C) should be kept under close supervision (see PRECAUTIONS and PHARMACOLOGY: Pharmacokinetics under ACTIONS).
Renal impairment: No dosage adjustment of Femara is required for patients with renal insufficiency with (creatinine clearance (CLcr ≥10 mL/min). Insufficient data are available in cases of renal insufficiency with CLcr <10 mL/min (see PRECAUTIONS and PHARMACOLOGY: Pharmacokinetics under ACTIONS).
Pediatrics: Femara is not recommended for use in children and adolescents. The safety and efficacy of Femara 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.
Geriatrics: No dose adjustment is required for elderly patients.
Method of administration: Femara should be taken orally and can be taken with or without food because food has no effect on the extent of absorption.
Missed dose: The missed dose should be taken as soon as the patient remembers. However, if it is almost time for the next dose, 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).