PMS-Entecavir

PMS-Entecavir Indications/Uses

entecavir

Manufacturer:

Pharmascience

Distributor:

Medicell Pharma
Full Prescribing Info
Indications/Uses
pms-ENTECAVIR (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 pms-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 Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
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 Pharmacology: Pharmacodynamics: Clinical Studies: Outcomes at 48 Weeks under Actions].
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 Patients Co-infected with HIV and HBV under Precautions and Pharmacology: Pharmacodynamics: Clinical Studies: Outcomes at 48 Weeks under Actions].
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