- Approval Id
- 5a270fbb31dee9cb
- Drug Name
- HEPURI F.C. TABLETS 0.5 MG
- Product Name
- HEPURI F.C. TABLETS 0.5 MG
- Approval Number
- SIN16090P
- Approval Date
- 2021-01-28
- Registrant
- NOVEM HEALTHCARE PTE LTD
- Licence Holder
- NOVEM HEALTHCARE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong><em>2.1</em> Recommended Dosage</strong></p>
<p><strong>Compensated Liver Disease</strong><br>
The recommended dose of HEPURI for chronic hepatitis B virus infection in nucleoside- treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily, with or without food.<br>
The recommended dose of HEPURI in adults and adolescents (≥16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine resistance mutations is 1 mg once daily, which must be taken on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).</p>
<p><strong>Decompensated Liver Disease</strong><br>
The recommended dose of HEPURI for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily, which must be taken on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).</p>
<p><strong><em>2.2</em> Renal Impairment</strong><br>
In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see <em>Clinical Pharmacology (10.2)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]. Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 1. The once-daily dosing regimens are preferred.</p>
<img src="/TGIF/Hepuri-Table1.png" alt="Hepuri Dosage Table 1" /><br><br>
<p><strong><em>2.3</em> Hepatic Impairment</strong><br>
No dosage adjustment is necessary for patients with hepatic impairment.</p>
<p><strong><em>2.4</em> Duration of Therapy</strong><br>
The optimal duration of treatment with Entecavir for patients with chronic hepatitis B virus infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>HEPURI is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.</p>
<p>The following points should be considered when initiating therapy with HEPURI:</p>
<ul class ="nobull">
<li>→ This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease [see <em>Clinical Studies (12)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</li>
<li>→ Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease [see <em>Adverse Reactions (5)</em> and <em>Clinical Studies (12.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</li>
<li>→ Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy [see <em>Warnings and Precautions (4.2)</em> and <em>Clinical Studies (12.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</li>
</ul>
- Contraindications
- <p><strong>3 CONTRAINDICATIONS</strong></p>
<p>Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to entecavir or any component of the product.</p>
- Atc Code
- J05AF10
- Atc Item Name
- entecavir
- Pharma Manufacturer Name
- NOVEM HEALTHCARE PTE LTD
- Company Detail Path
- /organization/novem-healthcare-pte-ltd
