Received November 10, 2005
Accepted on March 12, 2006

ORIGINAL ARTICLES

Safety and Adverse Events Profiles of Intravenous Gammaglobulin Products Used for Immunomodulation: A Single-Center Experience

Ashley A. Vo ^*1, Vinh Cam ^*, Mieko Toyoda , Dechu P. Puliyanda ^*, Marina Lukovsky ^*, Suphamai Bunnapradist ^*, Alice Peng ^*, Kai Yang , and Stanley C. Jordan ^*

*Comprehensive Transplant Center, Transplant Immunology Laboratory, and Department of Medical Genetics, Cedars-Sinai Medical Center, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California

¹ To whom correspondence should be addressed. E-mail: ashley.vo{at}cshs.org.

	Abstract

Intravenous Ig (IVIg) products are used in various medical conditions. Differences in excipients account for most adverse events (AE). Reports of complications including acute myocardial infarction (AMI) and acute renal failure (ARF) have emerged. Herein is described one institution’s experience with IVIg-related complications. This study is a retrospective analysis of infusion-related AE that are associated with various IVIg products. Infusion-related AE were monitored during and after the administration of three IVIg products: Gamimune-N 10% (n = 76), Polygam (n = 105), and Carimune (n = 98). AE segregated to specific IVIg products. No patients who received Gamimune-N experienced AMI or ARF. Five (4.7%) patients (P < 0.01) in the Polygam group experienced AMI. Eight (8.2%) patients (P < 0.0001) in the Carimune group developed ARF. IVIg was safe to give on hemodialysis. IVIg products differ in osmolality, pH, and sugar and sodium content; this results in specific AE. Polygam resulted in no ARF but an increase in AMI. Carimune products at 9% concentration resulted in an increase in ARF. Gamimune-N 10% and other IVIg products were frequently associated with headaches. Administration of IVIg to patients who are on hemodialysis seems to be safe and effective.