HEPSERA is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg-chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.
For patients 12 to less than 18 years of age, the indication is based on virological and biochemical responses in patients with HBeAg+ chronic hepatitis B virus infection with compensated liver function.
DOSAGE AND ADMINISTRATION
Chronic Hepatitis B
The recommended dose of HEPSERA in chronic hepatitis B patients for patients 12 years of age and older with adequate renal function is 10 mg, once daily, taken orally, without regard to food. The optimal duration of treatment is unknown.
HEPSERA is not recommended for use in children less than 12 years of age.
Dose Adjustment in Renal Impairment
Significantly increased drug exposures were seen when HEPSERA was administered to adult patients with renal impairment [See WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. Therefore, the dosing interval of HEPSERA should be adjusted in adult patients with baseline creatinine clearance less than 50 mL per minute using the following suggested guidelines (See Table 1). The safety and effectiveness of these dosing interval adjustment guidelines have not been clinically evaluated.
Additionally, it is important to note that these guidelines were derived from data in patients with pre-existing renal impairment at baseline. They may not be appropriate for patients in whom renal insufficiency evolves during treatment with HEPSERA. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.
Table 1 : Dosing Interval Adjustment of HEPSERA in
Adult Patients with RenalImpairment
|Creatinine Clearance (mL/min)a||Hemodialysis Patients|
|Greater than or equal to 50||30–49||10–29|
|Recommended dose and dosing interval||10 mg every 24 hours||10 mg every 48 hours||10 mg every 72 hours||10 mg every 7 days following dialysis|
|aCreatinine clearance calculated by Cockcroft-Gault method using lean or ideal body weight.|
The pharmacokinetics of adefovir have not been evaluated in non-hemodialysis patients with creatinine clearance less than 10 mL per minute; therefore, no dosing recommendation is available for these patients.
No clinical data are available to make dosing recommendations in adolescent patients with renal insufficiency [See WARNINGS AND PRECAUTIONS].
Dosage Forms And Strengths
HEPSERA is available as tablets. Each tablet contains 10 mg of adefovir dipivoxil. The tablets are white and debossed with “10” and “GILEAD” on one side and the stylized figure of a liver on the other side.
Storage And Handling
HEPSERA is available as tablets. Each tablet contains 10 mg of adefovir dipivoxil. The tablets are white and debossed with “10” and “GILEAD” on one side and the stylized figure of a liver on the other side. They are packaged as follows: Bottles of 30 tablets (NDC 61958-0501-1) containing desiccant (silica gel) and closed with a child-resistant closure.
Store in original container at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (See USP Controlled Room Temperature).
Do not use if seal over bottle opening is broken or missing.
Manufactured for: Gilead Sciences, Inc. Foster City, CA 94404. November 2012
Last reviewed on RxList: 12/7/2012
This monograph has been modified to include the generic and brand name in many instances.
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