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A pharmacokinetic and dosing study of intravenous insulin-like growth factor-I and IGF-binding protein-3 complex to preterm infants

Journal article
Authors Chatarina Löfqvist
Aimon Niklasson
Eva Engström
L. E. Friberg
C. Camacho-Hubner
D. Ley
J. Borg
L. E. Smith
Ann Hellström
Published in Pediatric Research
Volume 65
Issue 5
Pages 574-9
ISSN 1530-0447
Publication year 2009
Published at Institute of Neuroscience and Physiology, Department of Clinical Neuroscience and Rehabilitation
Institute of Clinical Sciences
Pages 574-9
Language en
Links dx.doi.org/10.1203/PDR.0b013e31819d...
Keywords Birth Weight, Female, Gestational Age, Half-Life, Humans, Infant, Newborn, *Infant, Premature, Infusions, Intravenous, Insulin-Like Growth Factor Binding Proteins/*administration &, dosage/adverse effects/blood/*pharmacokinetics, Insulin-Like Growth Factor I/*administration & dosage/adverse, effects/*pharmacokinetics, Male, Recombinant Proteins/administration & dosage/pharmacokinetics
Subject categories Medical and Health Sciences

Abstract

In preterm infants, low levels of insulin like growth factor 1 (IGF-I) have been associated with impaired growth and retinopathy of prematurity. Our objective was to study safety and pharmacokinetics of i.v. administered rhIGF-I with its binding protein 3 (rhIGFBP-3) to preterm infants. At 3 d chronological age, an i.v. 3 h infusion of rhIGF-I/rhIGFBP-3 was administered followed by serial measurements of IGF-I and IGFBP-3. Infants were evaluated for physiologic safety measurements. The individual dose of rhIGF-I ranged from 1 to 12 microg/kg. The study was conducted at Queen Silvia Children's Hospital, Gothenburg, Sweden, between January and November 2007. Five patients (3 F) with mean (range) post menstrual age 27 wk (26-29) and birth weight 1022 g (810-1310) participated. IGF-I and IGFBP-3 levels before infusion were median (range) 18 (12-28) and 771 (651-1047) ng/mL, respectively. Immediately after study drug infusion, serum IGF-I and IGFBP-3 levels were 38 (25-59) and 838 (754-1182) ng/mL, respectively. Median (range) half-life for IGF-I and IGFBP-3 was 0.79 (0.59-1.42) and 0.87 (0.85-0.94) hours, respectively. Blood glucose, insulin, sodium, potassium, and physiologic safety measures were within normal ranges. The rhIGF-I/rhIGFBP-3 equimolar proportion was effective in increasing serum IGF-I levels and administration under these study conditions was safe and well tolerated.

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