Generic name: adefovir dipivoxil 10mg
Dosage form: tablet
Drug class: Nucleoside reverse transcriptase inhibitors (NRTIs)
Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.
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 (5.2) and Clinical Pharmacology (12.3)]. 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.
|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|
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 (5.2)].
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