Pharmacokinetics and Pharmacodynamics of Pegfilgrastim in Subjects With Various Degrees of Renal Function


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Abstract

A phase I study was conducted to evaluate the effects of renal function on the pharmacokinetics and pharmacodynamics (absolute neutrophil count [ANC]) of pegfilgrastim in nonneutropenic subjects. Thirty subjects categorized into 5 renal function groups (normal, mildly impaired, moderately impaired, severely impaired, and end-stage renal disease) received 1 subcutaneous injection of pegfilgrastim at 6 mg. The ANC profiles after pegfilgrastim administration were similar across different renal function groups. No discernable correlation between pharma-cokinetic parameter values and degree of renal impairment was observed; the mean values ranged from 147 to 201 ng/mL for Cmax and from 7469 to 8513 ngxh/mL for AUC. Results suggest that the kidney has no important role in the elimination of pegfilgrastim. Therefore, no dosage adjustment for renal impairment is indicated for pegfilgrastim.

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