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.
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
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Creatinine Clearance (mL/min)Creatinine clearance calculated by Cockcroft-Gault method using lean or ideal body weight.
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≥50 |
30–49
|
10–29
|
Hemodialysis 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.
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