title: Pharmacokinetics of intravenous immunoglobulin in neonates.
abstract: 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.
authors.affiliation: Department of Pediatrics, Uniformed Services University, Bethesda, Md.
authors.forename: L E
authors.initials: LE
authors.lastname: Weisman
authors.forename: G W
authors.initials: GW
authors.lastname: Fischer
authors.forename: P
authors.initials: P
authors.lastname: Marinelli
authors.forename: V G
authors.initials: VG
authors.lastname: Hemming
authors.forename: J R
authors.initials: JR
authors.lastname: Pierce
authors.forename: S M
authors.initials: SM
authors.lastname: Golden
authors.forename: C C
authors.initials: CC
authors.lastname: Peck
mesh_terms: 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
chemical_list: D000900:Anti-Bacterial Agents; D007074:Immunoglobulin G; D007136:Immunoglobulins