title: Safety and adverse events profiles of intravenous gammaglobulin products used for immunomodulation: a single-center experience.
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.
authors: Comprehensive Transplant Center, Cedars-Sinai Medical Center, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California 90048, USA. ashley.vo@cshs.org
authors: Ashley A
authors: AA
authors: Vo
authors: Vinh
authors: V
authors: Cam
authors: Mieko
authors: M
authors: Toyoda
authors: Dechu P
authors: DP
authors: Puliyanda
authors: Marina
authors: M
authors: Lukovsky
authors: Suphamai
authors: S
authors: Bunnapradist
authors: Alice
authors: A
authors: Peng
authors: Kai
authors: K
authors: Yang
authors: Stanley C
authors: SC
authors: Jordan
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced* / Q000453:epidemiology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects*; D007155:Immunologic Factors / Q000009:adverse effects*; D007223:Infant; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced* / Q000453:epidemiology; D012189:Retrospective Studies; D012449:Safety
chemical_list: D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors