PMS-ENTECAVIR FILM COATED TABLET 0.5MG [SIN16094P]

Product Info

PMS-ENTECAVIR FILM COATED TABLET 0.5MG

[SIN16094P]

1 INDICATIONS AND USAGE

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 Clinical Studies (12) – 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 (5) and Clinical Studies (12.1) – 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 (4.2) and Clinical Studies (12.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Compensated Liver Disease

The recommended dose of pms-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 pms-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 pms-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).

2.2 Renal Impairment

In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology (10.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. 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.

2.3 Hepatic Impairment

No dosage adjustment is necessary for patients with hepatic impairment.

2.4 Duration of Therapy

The optimal duration of treatment with pms-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.

3 CONTRAINDICATIONS

pms-ENTECAVIR is contraindicated in patients with previously demonstrated hypersensitivity to entecavir or any component of the product.