Posology : מינונים

4.2    Posology and method of administration
Posology
Adult and elderly patients
The recommended dose of Femara is 2.5 mg once daily. No dose adjustment is required for elderly patients.

In patients with advanced or metastatic breast cancer, treatment with Femara should continue until tumour progression is evident.


FEM API OCT20 V1                                                        REF UK SMPC APR 2020 In the adjuvant and extended adjuvant setting, treatment with Femara should continue for 5 years or until tumour relapse occurs, whichever is first.

Paediatric population
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.

Renal impairment
No dosage adjustment of Femara 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 (see sections 4.4 and 5.2).

Hepatic impairment
No dose adjustment of Femara is required for patients with mild to moderate hepatic insufficiency (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 (see sections 4.4 and 5.2).

Method of administration
Femara 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 section 5.2).