Fempro (Letrozole) 2.5mg

Fempro (Letrozole) 2.5mg is an aromatase inhibitor indicated for:

1. Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer

2.  Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy

3. First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer

Letrozole Dosage: 

The recommended dose of Fempro Tablets is one 2.5 mg tablet administered once a day, without regard to meals.

In the adjuvant setting, treatment with Fempro Tablets should continue for 5 years or until tumour relapse occurs, whichever comes first.

Following standard adjuvant tamoxifen therapy, treatment with Fempro Tablets should continue for 5 years or until tumour relapse occurs, whichever comes first.In the adjuvant setting a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered.In patients with metastatic disease, treatment with Fempro Tablets should continue until tumour progression is evident.In the neoadjuvant setting, treatment with Letrozole could be continued for 4 to 8 months in order to establish optimal tumour reduction. If the response is not adequate, treatment with Letrozole should be discontinued and surgery scheduled and/or further treatment options discussed with the patient.Regular monitoring to observe progression during the pre-operative treatment period is recommended.No dose adjustment is required for elderly patients.

Pediatric 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 but no recommendation on a posology can be made.

Use in Hepatic Impairment

No dosage adjustment is recommended for patients with mild-to-moderate hepatic impairment, although letrozole blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50%. The recommended dose of letrozole for such patients is 2.5 mg administered every other day. Patients with severe hepatic impairment (Child-Pugh score C) should be kept under close supervision. The effect of hepatic impairment on letrozole exposure in non-cirrhotic cancer patients with elevated bilirubin levels has not been determined.

Use in Renal Impairment

No dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥10 mL/min. Insufficient data are available in cases of renal insufficiency with creatinine clearance lower than 10 ml/min.Contraindications1.Known hypersensitivity to the active substance or to any of the excipients.2.Pregnant women and nursing mothers:Pregnancy Category X.Letrozole is contraindicated in pregnant women and nursing mothers. Letrozole may cause foetal harm when administered to a pregnant woman. If letrozole is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the foetus.

Premenopausal women: Letrozole is contraindicated in women who may become pregnant.