- Approval Id
- 11d95660e83b4781
- Drug Name
- Letrozole Mevon Tablets 2.5mg
- Product Name
- Letrozole Mevon Tablets 2.5mg
- Approval Number
- SIN13916P
- Approval Date
- 2011-02-07
- Registrant
- NOVEM HEALTHCARE PTE LTD
- Licence Holder
- NOVEM HEALTHCARE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Adults and elderly patients</u><br>
The recommended dose of Letrozole is 2.5 mg once daily.</p>
<p>In the extended adjuvant setting, the optimal treatment duration with Letrozole is not known. The planned duration of treatment in the study was 5 years. However at the time of the analysis, the median treatment duration was 24 months. 25% of patients were treated for at least 3 years and less than 1% of patients were treated for the planned duration of 5 years. The median duration of follow up was 28 months.<br>
Treatment should be discontinued at tumour relapse. In patients with metastatic disease, treatment with Letrozole should continue until tumour progression is evident. No dose adjustment is required for elderly patients.</p>
<p>In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. The planned duration of treatment in the study is 5 years. However, at the time of analysis, the median duration of treatment was 24 months, median duration of follow-up was 26 months, and 16% of the patients have been treated for 5 years. Treatment should be discontinued at relapse.</p>
<p><u>Children</u><br>
Not applicable.</p>
<p><u>Patients with hepatic and/or renal impairment</u><br>
No dosage adjustment is required for patients with hepatic impairment or renal impairment (creatinine clearance ≥10 mL/min.). However, the dose of Letrozole in patients with cirrhosis and severe hepatic dysfunction (Child-Pugh score C) should be reduced by 50% (see PHARMACOKINETICS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). The recommended dose of letrozole for such patients is 2.5mg administered every other day. Patients with severe hepatic impairment should be kept under close supervision (see section PHARMACOKINETICS – <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>Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.</p>
<p>Extended adjuvant treatment of early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy.</p>
<p>First-line treatment in postmenopausal women with advanced hormone-dependent breast cancer.</p>
<p>Treatment of advance breast cancer in women with natural or artificially induced postmenopausal status, who have previously been treated with antioestrogens.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients. Pre-menopausal endocrine status; pregnancy and lactation (see section 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
- NOVEM PHARMA PRIVATE LIMITED
