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PHARMACOKINETICS

Effect of Renal Function on the Pharmacokinetics of Palifermin

B. Gillespie, PharmD, P. Zia-Amirhosseini, PhD, M. Salfi, MS, T. Kakkar, PhD, J. Wang, MS, MBA, S. Gupta, PhD, B. Smith, PhD, R. Robson, MB ChB, PhD, FRACP and J. T. Sullivan, MB, ChB, FRACP

From Amgen Inc, Thousand Oaks, California (Dr Gillespie, Dr Zia-Amirhosseini, Ms Salfi, Dr Kakkar, Ms Wang, Dr Gupta, Dr Smith, Dr Sullivan), and Christchurch Clinical Studies Trust, Christchurch, New Zealand (Dr Robson).

Palifermin ({Delta}N23KGF) decreases the incidence, severity, and duration of oral mucositis. The objectives of this open-label study were to evaluate the pharmacokinetics of single-dose palifermin in subjects with varying degrees of renal function. A single 90-mcg/kg intravenous dose of palifermin was administered to 31 subjects with varying levels of renal function (normal to requiring hemodialysis). Pharmacokinetic analyses were conducted using serum palifermin concentrations. There was considerable overlap in mean palifermin serum clearance among the groups, ranging from 318 to 495 mL/h/kg, indicating that the level of renal function did not affect clearance in humans; thus, no dose adjustment of palifermin is indicated for patients with renal dysfunction.

Key Words: Palifermin • renal clearance • keratinocyte growth factor • chronic kidney disease • mucositis

Address for reprints: Address for correspondence: B. Gillespie, PharmD, Amgen Inc, One Amgen Center Drive, MS 38-3-A, Thousand Oaks, CA 91320-1799; e-mail: bgillesp{at}amgen.com.


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