LETROVITAE FILM-COATED TABLETS 2.5MG [SIN16037P]

Product Info

LETROVITAE FILM-COATED TABLETS 2.5MG

[SIN16037P]

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 progression of the disease in women with natural or artificially induced postmenopausal endocrine state, who have been previously treated with anti-estrogens.

4.2. Posology and method of administration
Adult
The recommended dose of letrozole is 2.5 mg once daily. In the adjuvant and extended adjuvant setting, treatment with Letrovitae should continue for 5 years or until disease relapse/recurrence, whichever comes first.

In patients with advanced or metastatic breast cancer, treatment with letrozole should continue until the progression of the tumor is evident.

Special populations

Paediatric population
The use of Letrovitae in children and adolescents is not recommended. The safety and efficacy of Letrovitae in children and adolescents up to 17 years of age have not been established. Limited data are available and a dosage recommendation cannot be made.

Geriatric patients (65 years of age or older)
No dose adjustment is required for elderly patients.

Renal impairment
No dose adjustment of Letrovitae is required for patients with renal insufficiency with a creatinine clearance (Cl_cr) ≥ 10 ml / min. Sufficient data are not available for cases of renal insufficiency with a creatinine clearance below 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).

Patients with hepatic impairment
No dose adjustment of Letrovitae is required in patients with mild to moderate hepatic impairment (Child-Pugh A or B). There is not enough data available on patients with severe hepatic impairment. Patients with severe hepatic impairment (Child-Pugh C) need close monitoring (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

4.3. Contraindications

• Hypersensitivity to the active substance or to any of the excipients included in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Premenopausal endocrine status.

• Pregnancy (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Lactation (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).