Basic Information
VIRCLEAN F.C. TABLETS 300MG
TABLET, FILM COATED
Regulatory Information
SIN16078P
January 6, 2021
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XJ05AF07
Company Information
Active Ingredients
Strength: 300 mg
Detailed Information
Contraindications
**4 CONTRAINDICATIONS** None.
Indication Information
**1 INDICATIONS AND USAGE** **1.1 HIV-1 Infection** 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. The following points should be considered when initiating therapy with VIRCLEAN for the treatment of HIV-1 infection: - VIRCLEAN should not be used in combination with DESCOVY ® , GENVOYA ® , STRIBILD ® , TRUVADA ® or other products containing Tenofovir Disoproxil Fumarate or Tenofovir alafenamide \[See Warnings and Precautions (5.4) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. **1.2 Chronic Hepatitis B** 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: - 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 \[See Clinical Studies (13.2) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. - Tenofovir Disoproxil Fumarate was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease. \[See Adverse Reactions (6.1), Clinical Studies (13.2) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. - The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy \[See Microbiology (11.3), Clinical Studies (13.2) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. Tenofovir Disoproxil Fumarate is indicated for the treatment of chronic hepatitis B in adolescents 12 to <18 years of age with: - 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.