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The following list reviews several special populations who may require specific care relative to therapy with Hepsera® (adefovir dipivoxil). These populations include:
- Pediatric patients
- Geriatric patients
- Patients at risk of/with renal impairment
- Patients with hepatic impairment
- Pregnant women
- Lactating women
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Safety and effectiveness in pediatric patients have not been established. No pharmacokinetic data have been collected in this population.1
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Clinical studies of Hepsera did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, caution should be exercised when prescribing to elderly patients since they have greater frequency of decreased renal or cardiac function due to concomitant disease or other drug therapy. No pharmacokinetic data have been collected in this population.1
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In people at risk of or with moderately or severely impaired renal function or with end-stage renal disease (ESRD) requiring hemodialysis, Cmax, AUC and half-life (T1/2) were increased compared to subjects with normal renal function. It is recommended that the dosing interval of Hepsera be modified in these patients. Click here to review the dosing for Hepsera.1
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The pharmacokinetics of adefovir following a 10 mg 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.1
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There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Hepsera should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits.1
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It is not known whether Hepsera is excreted in human milk. Mothers should be instructed not to breast-feed if they are taking Hepsera.1
Click here for full Prescribing Information.
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