Pharmacokinetics of intravenous immunoglobulin in neonates.
Intravenous immunoglobulin (IVIG) may be a therapeutic adjunct to antibiotic treatment of neonatal infections. We examined the pharmacokinetics and safety of IVIG in human neonates. Thirty neonates with suspected sepsis were randomly assigned either to a treatment (receiving either 250, 500, or 1,000 mg/kg of IVIG plus antibiotics) or control (antibiotics alone) group. The 500 mg/kg dose produced a rise in total IgG for greater than 8 and in group B streptococcus (GBS) type-specific IgG for greater than 4-14 days. The type-specific antibody elevation varied with the amount of pathogen-specific antibody and dose of IVIG. Pharmacokinetic analysis suggests a Vdss of 42 ml/kg, Cl of 3.0 ml/kg/day, a biphasic elimination curve, and a terminal elimination half-life of 24.2 days. No toxicity was observed. These data may be valuable in determining optimal dosing schedules for IVIG in treating or preventing neonatal infections.
Weisman
L E
LE
Department of Pediatrics, Uniformed Services University, Bethesda, Md.
Fischer
G W
GW
Marinelli
P
P
Hemming
V G
VG
Pierce
J R
JR
Golden
S M
SM
Peck
C C
CC
D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001424:Bacterial Infections / Q000188:drug therapy / Q000628:therapy*; D005260:Female; D006801:Humans; D007116:Immunization, Passive; D007074:Immunoglobulin G / Q000032:analysis*; D007136:Immunoglobulins / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D008297:Male; D016032:Randomized Controlled Trials as Topic; D013292:Streptococcus agalactiae / Q000276:immunology
D000900:Anti-Bacterial Agents; D007074:Immunoglobulin G; D007136:Immunoglobulins