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0091270008320318v1
48/9/1025    most recent
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PHARMACOKINETICS AND PHARMACODYNAMICS/SPECIAL POPULATIONS

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

Bing-Bing Yang, PhD, Anna Kido, BS, Margaret Salfi, MS, Suzanne Swan, MD and John T. Sullivan, MB, ChB

From Amgen Inc, Thousand Oaks, California (Dr Yang, Ms Kido, Ms Salfi, Dr Sullivan) and DaVita Clinical Research and Hennepin County Med Center, Minneapolis, Minnesota (Dr Swan).

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.

Key Words: Pegfilgrastim • renal function • pharmacokinetics • pharmacodynamics

Address for reprints: Bing-Bing Yang, PhD, Amgen Inc, Departments of Pharmacokinetics & Drug Metabolism, Mail Stop: 28-3-B, Thousand Oaks, CA 91320; e-mail: byang{at}amgen.com.


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