Pediatric Patients

The pharmacokinetic profile of etanercept is similar in pediatric and adult patients. Mean steady-state peak serum concentrations of etanercept were similar in patients aged 4-17 years who received etanercept 0.4 mg/kg twice weekly for up to 18 weeks (2.1 mg/l) and in adults who received etanercept 25 mg twice weekly (2.4 mg/l) (Culy and Keating 2002). Pharmaco-kinetic modeling performed in patients aged 4-17 years showed that there were overlapping steady-state pharmacokinetic profiles for the 0.8-mg/kg once-weekly and the 0.4-mg/kg twice-weekly dosing regimens of etanercept. The respective peak concentrations were 2.9 and 2.6 mg/l, and the respective trough concentrations were 1.6 and 1.9 mg/l (Yim et al. 2005). In younger children (4-8 years), etanercept clearance may be slightly reduced (European Medicines Agency 2005; Enbrel: US Full Prescribing Information 2006), and a weight-based dosing schedule is warranted for pediatric patients (see "Indications" for more detailed prescribing information).

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