Tumor Necrosis Factor Alfa Antagonists for Pediatric Immune-Mediated Diseases

Marcia L. Buck, Pharm.D., FCCP

Pediatr Pharm. 2007;13(8):1-4. 

In This Article

Pharmacokinetics

All of the TNFα antagonists are administered parenterally. Infliximab is administered as an infusion, reaching mean serum concentrations of 0.5-6 mcg/mL.[6] The pharmacokinetic profile in children is similar to that of adults, with a terminal half-life of 8-10 days. Etanercept reaches a maximum concentration of 1-3 mcg/mL 60-70 hours after a subcutaneous dose. The average half-life of etanercept is 102 ± 30 hours.[7] A pharmacokinetic analysis was performed in the 69 children enrolled in the pediatric etanercept study described previously.[10] Using non-linear mixed effects modeling, the predicted mean trough concentration was 1.58 ± 1.07 mcg/mL for 0.8 mg/kg once weekly dosing and 1.92 ± 1.09 mcg/mL for 0.4 mg/kg twice weekly dosing, suggesting that the regimens were equivalent.[16]

In a study of adults receiving adalimumab, maximum concentrations of 4.7 ± 1.6 mcg/mL were reached 131 ± 56 hours following a single 40 mg dose.[8] The volume of distribution ranged from 4.7 to 6 L, with a systemic clearance rate of 12 mL/hr. The mean elimination half-life was 14 days (range 10-20 days). Administration with methotrexate reduces the clearance of adalimumab, but no adjustment is necessary in patients on combination therapy. The pharmacokinetic profile of adalimumab has not been assessed in children.

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