Pharmacokinetics and pharmacodynamics of pegfilgrastim in subjects with various degrees of renal function.
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 C(max) and from 7469 to 8513 ng x h/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.
Amgen Inc, Thousand Oaks, CA 91320, USA. byang@amgen.com
Bing-Bing
BB
Yang
Anna
A
Kido
Margaret
M
Salfi
Suzanne
S
Swan
John T
JT
Sullivan
D000328:Adult; D000368:Aged; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D006801:Humans; D007279:Injections, Subcutaneous; D007674:Kidney Diseases / Q000097:blood / Q000378:metabolism* / Q000628:therapy; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009504:Neutrophils / Q000187:drug effects*; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D006435:Renal Dialysis; D012720:Severity of Illness Index
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim