Intravenous immunoglobulin (IVIG) is a sterile, highly purified immunoglobulin G (IgG) derived from large pools of human plasma. All units of human plasma used to prepare IVIG are provided by FDA approved blood establishments (Red Cross) and tested by FDA-licensed serological tests for infectious agents. Aside from screening for hepatitis, HIV and nucleic acid tests, significant viral reduction is achieved by a combination of processes including Cohn fractionation, pH 4 and solvent detergent treatments. The product is stable for 18 months at room temperature and 24 months in the refrigerator.
The FDA approved indication of IVIG is primarily immune deficiency syndromes such as agammaglobulinemia, Wiscott-Aldrich syndrome, or combined immunodeficiencies ("boy in the bubble"). In the US, 70-80% of IVIG used is off-label use for a variety of diseases. Some of these include but are not limited to rheumatoid arthritis, ITP, Alzheimer's disease, hemophilias, autism, ulcerative colitis, Crohn's disease and recurrent pregnancy loss (RPL). The cost of the preparation is approximately $70 per gram. A total of 40-80 grams of IVIG is recommended and divided i