Safety and Adverse Events Profiles of Intravenous Gammaglobulin Products Used for Immunomodulation

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.

Acute Hemolysis After High-Dose Intravenous Immunoglobulin Therapy in Highly HLA Sensitized Patients

“…Our group has extensive experience with monitoring the efficacy and safety of IVIG products used in desensitization and for the treatment of AMR (8,9,17). However, our recent experience with newer, isosmolar, liquid products has shown an unexpected risk of IH that was not seen with older products and seems to be related to an increased titer of anti-A/B antibodies in liquid IVIG products.…”

“…However, this is likely not feasible at all medical centers because of pharmacy purchasing practices. In addition, side effects such as acute renal failure or thrombosis can occur with the higher osmolar products, thereby limiting their use in some situations (8). There has been mixed success preventing hemolytic reactions by removing the antibodies from the IVIG product in vitro (20,21).…”

“…Some common side effects of IVIG infusion include pyrexia, rigors, and headache (7). Rare, but significant, adverse events include acute kidney injury related to sucrose induced osmotic nephropathy, hypersensitivity reactions, and vascular thrombosis (7,8). Our group has extensive experience with the use of IVIG products in highly HLA-sensitized ESRD patients on dialysis and renal allograft recipients with AMR.…”

“…Our group has extensive experience with the use of IVIG products in highly HLA-sensitized ESRD patients on dialysis and renal allograft recipients with AMR. The overall safety profile of selected products has been extensively studied and previously described in the population (8,9).…”

Guillain-Barré syndrome following heart transplantation complicated by myocardial infarction following treatment with IVIg

“…Furthermore, a retrospective study at Cedars-Sinai Medical Center found that all five of their patients that suffered IVIg associated myocardial infarction had received a preparation with a particularly high osmolality (1,179 mOsm/kg). [39] Our institution uses Gammagard 10% (Baxter industries), the osmolality of which is 240-300 mOsm/kg, which is similar to physiologic osmolality. The reason why our patient would suffer from apparent hyperviscosity and acute myocardial infarction after receiving this infusion is unclear; however, the temporal relationship between administration of IVIg and development of symptoms makes this a compelling explanation.…”