Active Ingredient and Strength	LETROZOLE - 2.5 MG
Dosage Form	TABLET, FILM COATED
Manufacturer and Country	NOVARTIS PHARMA STEIN AG - SWITZERLAND NOVARTIS FARMA S.P.A. - ITALY
Registration Number	SIN14565P
Licence Holder	SANDOZ SINGAPORE PTE. LTD.
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	L02BG04

4.1 Therapeutic indications

Letrozole is not indicated in hormone receptor negative disease.

Letrozole is indicated in:

Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
Extended adjuvant treatment of invasive early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for five years.
First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
Treatment of advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-estrogens.

4.2 Posology and method of administration

Adults

The recommended dose of letrozole is 2.5 mg once daily. In the adjuvant and extended adjuvant setting, treatment with letrozole should continue for 5 years or until disease relapse/recurrence occurs, whichever comes first. In patients with metastatic disease, treatment with letrozole should continue until tumor progression is evident.

Special populations

Hepatic impairment

No dose adjustment of letrozole 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 sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

No dosage adjustment of letrozole 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 sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients

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 no recommendation on a posology can be made.

Geriatric patients (65 years of age or older)

No dose adjustment is required for elderly patients.

Method of administration

Letrozole 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 section 5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Known hypersensitivity to the active substance or to any of the excipients.
Premenopausal endocrine status; pregnancy, lactation (see sections 4.6 and 5.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).