ENTECAVIR STELLA FILM-COATED TABLET 0.5MG [SIN16519P]
Active ingredients: ENTECAVIR STELLA FILM-COATED TABLET 0.5MG
Last updated 24 April 2026
Product Info
ENTECAVIR STELLA FILM-COATED TABLET 0.5MG
[SIN16519P]
Product information
Active Ingredient and Strength | ENTECAVIR MONOHYDRATE EQV ENTECAVIR - 0.5 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | STELLAPHARM J.V. CO., LTD. - BRANCH 1 - VIETNAM SOC REP OF |
Registration Number | SIN16519P |
Licence Holder | AUXILTO IMPEX PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J05AF10 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
5. Indications
Entecavir STELLA 0.5 mg film-coated tablet 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 Special warnings and precautions for use and Clinical studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
Dosing
6. Administration and dosage
Administration
Entecavir STELLA 0.5 mg film-coated tablet should be taken orally.
Dosage
– Compensated liver disease
The recommended dose of entecavir 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.
The recommended dose of entecavir 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).
– Decompensated liver disease
The recommended dose of entecavir 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).
Special population
– Patients with renal impairment
In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased. 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.
– Patients with hepatic impairment
No dosage adjustment is required in patients with hepatic impairment.
Duration of therapy
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.
Contraindications
7. Contraindications
Hypersensitivity to the active substance or to any of the excipients of the product.