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Pharmacokinetics and effects of recombinant human erythropoietin after
intravenous and subcutaneous injections in healthy volunteers
FG McMahon, R Vargas, M Ryan, AK Jain, RI Abels, B Perry and IL Smith
Clinical Research Center, New Orleans, LA 70112.
A double-blind, placebo-controlled study of the pharmacokinetics and safety
of multiple doses of recombinant human erythropoietin [rHuEPO 150 or 300
U/kg either by intravenous (IV) bolus or subcutaneously (SC)] in normal
male subjects demonstrated that rHuEPO had a dose- related effect on the
hematocrit independent of the route of administration and that multiple
doses of rHuEPO had no direct pressor effects. When rHuEPO was injected IV,
a monoexponential decrease in serum EPO level was evident for 18 to 24
hours postdose. Absorption of SC injected rHuEPO occurred more slowly, with
relatively low serum EPO levels being maintained for 48 hours. All rHuEPO
antibody titer determinations were negative. With the exception of
significant increases in hemoglobin and hematocrit, no clinically
significant changes occurred. No hypertensive, convulsive, or thrombotic
events were observed. Of the adverse experiences observed in 10 subjects,
none was considered clinically significant, and none of the subjects
dropped out because of adverse experiences.
Volume 76,
Issue 9,
pp. 1718-1722,
11/01/1990
Copyright © 1990 by The American Society of Hematology
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