- Approval Id
- a30554e56c7ab861
- Drug Name
- VIRCLEAN F.C. TABLETS 300MG
- Product Name
- VIRCLEAN F.C. TABLETS 300MG
- Approval Number
- SIN16078P
- Approval Date
- 2021-01-06
- 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>2.1 Testing Prior to Initiation of Tenofovir Disoproxil Fumarate for Treatment of HIV-1 Infection or Chronic Hepatitis B</strong><br>
Prior to or when initiating Tenofovir Disoproxil Fumarate, test patients for HBV infection and HIV-1 infection. Tenofovir Disoproxil Fumarate alone should not be used in patients with HIV-1 infection [see Warnings and Precautions (5.3) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
<p>Prior to initiation and during use of Tenofovir Disoproxil Fumarate, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.2) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
<p><strong>2.2 Recommended Dose in Adults and Pediatric Patients 12 Years of Age and Older (35 kg or more)</strong></p>
<p>For the treatment of HIV-1 or chronic hepatitis B: The dose is one 300 mg VIRCLEAN tablet once daily taken orally, without regard to food.</p>
<p>In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. Safety and efficacy in pediatric patients with chronic hepatitis B weighing less than 35 kg have not been established.</p>
<p><strong>2.3 Dose Adjustment for Renal Impairment in Adults</strong></p>
<p>Significantly increased drug exposures occurred when Tenofovir Disoproxil Fumarate was administered to subjects with moderate to severe renal impairment [See Clinical Pharmacology (11.2) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]. Therefore, the dosing interval of Tenofovir Disoproxil Fumarate should be adjusted in patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring hemodialysis. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment; therefore, clinical response to treatment and renal function should be closely monitored in these patients [See Warnings and Precautions (5.2) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
<p>No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in patients with mild renal impairment [See Warnings and Precautions (5.2) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
<img src="/TGIF/Virclean-Table1.png" alt="Virclean Dosage Table 1" /><br><br>
<p>The pharmacokinetics of Tenofovir Disoproxil Fumarate have not been evaluated in non-hemodialysis patients with creatinine clearance below 10 mL/min; therefore, no dosing recommendation is available for these patients.</p>
<p>No data are available to make dose recommendations in pediatric patients 12 years of age and older with renal impairment.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p><strong>1.1 HIV-1 Infection</strong><br>
VIRCLEAN is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.</p>
<p>The following points should be considered when initiating therapy with VIRCLEAN for the treatment of HIV-1 infection:</p>
<ul class="nobull">
<li>VIRCLEAN should not be used in combination with DESCOVY ® , GENVOYA ® , STRIBILD ® , TRUVADA ® or other products containing Tenofovir Disoproxil Fumarate or Tenofovir alafenamide [See Warnings and Precautions (5.4) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</li>
</ul>
<p><strong>1.2 Chronic Hepatitis B</strong><br>
VIRCLEAN is indicated for the treatment of chronic hepatitis B in adults. The following points should be considered when initiating therapy with Tenofovir Disoproxil Fumarate for the treatment of chronic hepatitis B infection:</p>
<ul>
<li><p>The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [See Clinical Studies (13.2) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p></li>
<li><p>Tenofovir Disoproxil Fumarate was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease. [See Adverse Reactions (6.1), Clinical Studies (13.2) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p></li>
<li><p>The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy [See Microbiology (11.3), Clinical Studies (13.2) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p></li>
</ul>
<p>Tenofovir Disoproxil Fumarate is indicated for the treatment of chronic hepatitis B in adolescents 12 to <18 years of age with:</p>
<ul>
<li>Compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.</li>
</ul>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>None.</p>
- Atc Code
- J05AF07
- Atc Item Name
- tenofovir disoproxil
- Pharma Manufacturer Name
- NOVEM HEALTHCARE PTE LTD
