- Approval Id
- 3516201e47d37a1b
- Drug Name
- LETROZOLE SANDOZ FILM COATED TABLETS 2.5MG
- Product Name
- LETROZOLE SANDOZ FILM COATED TABLETS 2.5MG
- Approval Number
- SIN14565P
- Approval Date
- 2014-06-27
- Registrant
- SANDOZ SINGAPORE PTE. LTD.
- Licence Holder
- SANDOZ SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Adults</strong></p>
<p>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.</p>
<p><strong>Special populations</strong></p>
<p><strong>Hepatic impairment</strong></p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Renal impairment</strong></p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Pediatric patients</strong></p>
<p>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.</p>
<p><strong>Geriatric patients (65 years of age or older)</strong></p>
<p>No dose adjustment is required for elderly patients.</p>
<p><strong>Method of administration</strong></p>
<p>Letrozole should be taken orally and can be taken with or without food because food has no effect on the extent of absorption.</p>
<p><strong>Missed dose</strong></p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Letrozole is not indicated in hormone receptor negative disease.</p>
<p>Letrozole is indicated in:</p>
<ul>
<li><p>Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.</p></li>
<li><p>Extended adjuvant treatment of invasive early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for five years.</p></li>
<li><p>First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.</p></li>
<li><p>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.</p></li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Known hypersensitivity to the active substance or to any of the excipients.<br>
Premenopausal endocrine status; pregnancy, lactation (see sections 4.6 and 5.3 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- L02BG04
- Atc Item Name
- letrozole
- Pharma Manufacturer Name
- SANDOZ SINGAPORE PTE. LTD.
