Apart from lamivudine, trimethoprim/sulfamethoxazole, acetaminophen, and tenofovir disoproxil fumarate, the effects of co-administration of HEPSERA with drugs that are excreted renally, or other drugs known to affect renal function have not been evaluated.

The effect of adefovir on cyclosporine concentrations is not known.

No drug interaction studies have been performed in adolescent patients aged ≥ 12 years to < 18 years.

Special Populations

Gender

The pharmacokinetics of adefovir were similar in male and female patients.

Race

The pharmacokinetics of adefovir have been shown to be comparable in Caucasians and Asians. Pharmacokinetic data are not available for other racial groups.

Geriatric Patients

Pharmacokinetic studies have not been conducted in the elderly.

Pediatric Patients

The pharmacokinetics of adefovir were assessed from drug plasma concentrations in 53 HBeAg positive hepatitis B pediatric patients with compensated liver disease. The exposure of adefovir following a 48 week daily treatment with adefovir dipivoxil 10 mg

tablet in pediatric patients aged ≥ 12 to < 18 years (Cmax = 23.3 ng/ml and AUC_0-24 = 248.8 ng·h/ml) was comparable to that observed in adult patients. Renal Impairment In adults with moderately or severely impaired renal function or with end-stage renal disease (ESRD) requiring hemodialysis, Cmax, AUC, and half-life (T½) were increased compared to adults with normal renal function. It is recommended that the dosing interval of HEPSERA be modified in these patients (see DOSAGE AND ADMINISTRATION).

The pharmacokinetics of adefovir in non-chronic hepatitis B patients with varying degrees of renal impairment are described in Table 3. In this study, subjects received a 10 mg single dose of HEPSERA.

Table 3. Pharmacokinetic Parameters (Mean ±SD) of Adefovir in Patients with Varying Degrees of Renal Function

A four-hour period of hemodialysis removed approximately 35% of the adefovir dose. The effect of peritoneal dialysis on adefovir removal has not been evaluated.

The pharmacokinetics of adefovir have not been studied in adolescent patients with renal dysfunction (see Use in Specific Populations).

Hepatic Impairment

The pharmacokinetics of adefovir following a 10 mg single dose of HEPSERA have been studied in non-chronic hepatitis B patients with hepatic impairment. There were no substantial alterations in adefovir pharmacokinetics in patients with moderate and severe hepatic impairment compared to unimpaired patients. No change in HEPSERA dosing is required in patients with hepatic impairment.

Microbiology

Mechanism of Action

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