LETROCORD 2.5-LETROZOLE TABLETS 2.5MG USP [SIN16047P]

Product Info

LETROCORD 2.5-LETROZOLE TABLETS 2.5MG USP

[SIN16047P]

5. Indication
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.

6. Recommended Dosage

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

Special populations

Hepatic impairment
No dose adjustment of Letrocord 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 WARNINGS AND PRECAUTIONS and PHARMACOKINETICS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
No dosage adjustment of Letrocord 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 WARNINGS AND PRECAUTIONS and PHARMACOKINETICS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients
Letrocord is not recommended for use in children and adolescents. The safety and efficacy of Letrocord 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.

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

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