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First published on June 4, 2008, doi:10.1177/0091270008320318

The Journal of Clinical Pharmacology 2008;48:1025.

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©© 2008 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270008320318

Article

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

Bing-Bing Yang 1*, Anna Kido 1, Margaret Salfi 1, Suzanne Swan 2, and John T. Sullivan 1

1 Amgen Inc
2 DaVita Clinical Research and Hennepin County Med Center

* To whom correspondence should be addressed. E-mail: byang{at}amgen.com.


  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 pharmacokinetic 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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