Basic Information
TECAVIR FILM COATED TABLETS 0.5 MG
TABLET, FILM COATED
Regulatory Information
SIN16792P
May 23, 2023
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XJ05AF10
Company Information
Active Ingredients
Strength: 0.500 mg
Detailed Information
Contraindications
**CONTRAINDICATIONS** ENTECAVIR is contraindicated in patients with previously demonstrated hypersensitivity to entecavir or any component of the product.
Indication Information
**INDICATIONS AND USAGE** Entecavir 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. The following points should be considered when initiating therapy with Entecavir: 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 \[see _Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. - Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease \[see _Adverse Reactions_ and _Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. 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 \[see _Warnings and Precautions_ and _Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].