Safety and adverse events profiles of intravenous gammaglobulin products used for immunomodulation: a single-center experience.

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.

[1]  C. Nast,et al.  Current approaches to treatment of antibody‐mediated rejection , 2005, Pediatric transplantation.

[2]  J. Abe,et al.  Gene Expression Profiling of the Effect of High-Dose Intravenous Ig in Patients with Kawasaki Disease1 , 2005, The Journal of Immunology.

[3]  D. Stablein,et al.  Evaluation of intravenous immunoglobulin as an agent to lower allosensitization and improve transplantation in highly sensitized adult patients with end-stage renal disease: report of the NIH IG02 trial. , 2004, Journal of the American Society of Nephrology : JASN.

[4]  K. Sud,et al.  Intravenous immunoglobulin: a safe option for treatment of steroid-resistant rejection in the presence of infection. , 2004, Transplantation.

[5]  E. Kamil,et al.  Intravenous immune globulin treatment inhibits crossmatch positivity and allows for successful transplantation of incompatible organs in living-donor and cadaver recipients1 , 2003, Transplantation.

[6]  T. Larson,et al.  Overcoming a Positive Crossmatch in Living‐Donor Kidney Transplantation , 2003, American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons.

[7]  A. Daif,et al.  Thrombosis complicating high dose intravenous immunoglobulin: report of three cases and review of the literature , 2003, European journal of neurology.

[8]  D. Okuda,et al.  Arterial thrombosis induced by IVIg and its treatment with tPA , 2003, Neurology.

[9]  C. Cunningham-Rundles,et al.  Utility of Intravenous Immune Globulin in Kidney Transplantation: Efficacy, Safety, and Cost Implications , 2003, American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons.

[10]  S. Ford,et al.  Intravenous immunoglobulin therapy results in post‐infusional hyperproteinemia, increased serum viscosity, and pseudohyponatremia , 2003, American journal of hematology.

[11]  G. Lemm.  Composition and properties of IVIg preparations that affect tolerability and therapeutic efficacy , 2002, Neurology.

[12]  S. Gottlieb.  Intravenous immunoglobulin increases risk of thrombotic events , 2002, BMJ : British Medical Journal.

[13]  R. Dobson.  Children's hospital in Cardiff could drain resources from rest of Wales , 2002, BMJ : British Medical Journal.

[14]  S. Jordan,et al.  Treatment of Parvovirus B‐19 (PV B‐19) Infection Allows for Successful Kidney Transplantation Without Disease Recurrence , 2002, American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons.

[15]  J. Lewis,et al.  Rapid infusion of intravenous immune globulin in patients with neuromuscular disorders , 2001, Neurology.

[16]  S. Kaveri,et al.  Immunomodulation of autoimmune and inflammatory diseases with intravenous immune globulin. , 2001, The New England journal of medicine.

[17]  N. Ordóñez,et al.  Macrophagelike Vacuolated Renal Tubular Cells in the Urine of a Male with Osmotic Nephrosis Associated with Intravenous Immunoglobulin Therapy , 2000, Acta Cytologica.

[18]  M. Yaron,et al.  Acute myocardial infarction associated with high dose intravenous immunoglobulin infusion for autoimmune disorders. A study of four cases , 2000, Annals of the rheumatic diseases.

[19]  D. Warner,et al.  Acute Renal Failure after Large Doses of Intravenous Immune Globulin , 1999, The Annals of pharmacotherapy.

[20]  S. Kaveri,et al.  Inhibition of cell adhesion by antibodies to Arg-Gly-Asp (RGD) in normal immunoglobulin for therapeutic use (intravenous immunoglobulin, IVIg). , 1999, Blood.

[21]  S M Grundy,et al.  Primary prevention of coronary heart disease: guidance from Framingham: a statement for healthcare professionals from the AHA Task Force on Risk Reduction. American Heart Association. , 1998, Circulation.

[22]  J. Rosenbaum.  Myocardial infarction as a complication of immunoglobulin therapy. , 1997, Arthritis and rheumatism.

[23]  M. Dalakas.  High‐dose intravenous immunoglobulin and serum viscosity , 1994, Neurology.

[24]  W. Reinhart,et al.  Effect of high-dose intravenous immunoglobulin therapy on blood rheology , 1992, The Lancet.

[25]  R. Buckley,et al.  Rapid infusion of Sandoglobulin in patients with primary humoral immunodeficiency. , 1991, The Journal of allergy and clinical immunology.

[26]  A. Grigg,et al.  FATAL THROMBOTIC EVENTS DURING TREATMENT OF AUTOIMMUNE THROMBOCYTOPENIA WITH INTRAVENOUS IMMUNOGLOBULIN IN ELDERLY PATIENTS , 1986, The Lancet.

[27]  D. Greenblatt,et al.  A method for estimating the probability of adverse drug reactions , 1981, Clinical pharmacology and therapeutics.

[28]  M. Jaloudi,et al.  Thromboembolic events as an emerging adverse effect during high-dose intravenous immunoglobulin therapy in elderly patients: a case report and discussion of the relevant literature , 2005, Annals of Hematology.

[29]  C. Nast,et al.  Use of high-dose human intravenous immunoglobulin therapy in sensitized patients awaiting transplantation: the Cedars-Sinai experience. , 2003, Clinical transplants.

[30]  R. Go,et al.  Deep venous thrombosis of the arm after intravenous immunoglobulin infusion: case report and literature review of intravenous immunoglobulin-related thrombotic complications. , 2000, Mayo Clinic proceedings.

[31]  Renal insufficiency and failure associated with immune globulin intravenous therapy--United States, 1985-1998. , 1999, MMWR. Morbidity and mortality weekly report.

[32]  S. Grundy,et al.  Primary Prevention of Coronary Heart Disease: Guidance From Framingham A Statement for Healthcare Professionals From the AHA Task Force on Risk Reduction , 1998 .

[33]  C. Abendroth,et al.  Acute renal failure following immunoglobulin therapy. , 1996, American journal of nephrology.