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Hepsera (Adefovir Dipivoxil) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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 <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 with adequate renal function is 10 mg, once daily, taken orally, without regard to food. The optimal duration of treatment is unknown [see Warnings and Precautions].

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 <50 mL/min 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 Renal Impairment
Creatinine Clearance (mL/min)Creatinine clearance calculated by Cockcroft-Gault method using lean or ideal body weight.
≥5030–4910–29Hemodialysis Patients
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

The pharmacokinetics of adefovir have not been evaluated in non-hemodialysis patients with creatinine clearance <10 mL/min; 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.

HOW SUPPLIED / 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.

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