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Immune globulin is made from pooled plasma taken from thousands of donors.  It holds antibodies against a broad spectrum of bacteria and viruses.  It is used primarily to treat three categories of illnesses: primary immunodeficiencies, autoimmune neuromuscular disorders, and certain rheumatologic conditions.  Immune globulin is most commonly delivered through a needle placed into your vein (intravenously).  Immune globulin can also be given under the skin (subcutaneously) and through a muscle (intramuscular).

NOTE: immune globulin therapy is known as IgG, IGG, IVIG, IVIg, IGIV, immune globulin, immunoglobulin, immune globulin intravenous, and intravenous immune globulin.

What are the Different Formulations of Immune Globulin?
There are several different brands of IVIG that are on the market today.  Each brand has been approved by the Food and Drug Administration for specific diseases or indications.  Each brand has a different formula with different ingredients.   There are several types of differences in the IVIG formulas.

  • Form: Liquid or Powder
    Depending on the manufacturing process, the final product takes a liquid or lyophilized (freeze-dried powder) form.  Liquid preparations are considered to be more convenient and easier to use.  They may have fewer problems or adverse events.  In ready-to-use form, the liquid preparations take less time to prepare, so patients have fewer delays.  However, lyophilized preparations may last longer without having to be refrigerated.

  • Product Concentration
    The higher the concentration of the product, the smaller the volume.  (The manufacturing process determines the product concentration.)   The smaller the volume, the less time it takes to infuse the IVIG.  Some patients do better with a lower concentration and higher volume (longer infusions): sometimes shorter infusions lead to serious problems like kidney (renal) complications or blood clots.  At the same time, some patients—such as infants or patients with congestive heart failure or kidney insufficiency—cannot take the larger volumes with more fluid.  Usually the infusion is given slowly at first and then faster as long as the patient is comfortable with the rate of infusion.

  • Sugar Content
    Various sugars, such as sorbitol, glucose, maltose and sucrose, have been added to some preparations as a stabilizer and preservative in order to prevent any changes to the product.  The concern associated with sugar content is that there may be serious but rare problems such as acute kidney (renal) failure or insufficiency.  Some IVIG products have no sugar. 
  • pH
    The pH level is a measure how acid a solution is.  The optimum pH for IVIG to prevent changes is 4.0-4.5.  As a consequence, for preparations at higher pH levels, different ingredients are added to keep the product stable. There have been reports that low pH may be associated with phlebitis, an inflammation of a vein.

  • IgA Content
    Patients with selective IgA deficiency and the ability to produce antibodies may be at risk for developing IgE or IgG anti-IgA antibodies resulting in reactions, possibly anaphylaxis.

  • Antibody Titers
    There are clear differences in the levels of some antibodies among IVIG products, which can affect how effective the different IVIG product is for different patients.

What Diseases Does IVIG Treat?
IVIG has been used extensively in the treatment and prevention of a variety of infectious and inflammatory diseases. Patients with compromised immune systems who have these conditions often benefit from the passive immunity provided by IVIG therapy.

Patients with primary immunodeficiencies usually receive treatment therapy for life and patients being treated for autoimmune neuromuscular disorders and rheumatologic conditions can be treated for a more limited period which may be months or years and go into a remission.  Others receive the treatment for life.

The Food and Drug Administration has approved the use of IVIG for the following conditions:

  • Chronic B-cell lymphocytic leukemia
  • Chronic Inflammatory Demyelinating Polyneuropathy
  • Hematopoietic stem cell transplantation in patients older
    than 20 years
  • Immune-mediated thrombocytopenia
  • Kawasaki disease
  • Pediatric HIV type 1 infection
  • Primary immunodeficiencies

Medicare will typically cover IVIG for the following diseases (although coverage may vary by plan and/or region of the country)

  • Dermatomyositis
  • Guillain-Barré syndrome
  • Lambert-Eaton syndrome
  • Multifocal motor neuropathy
  • Multiple myeloma
  • Multiple sclerosis
  • Myasthenia gravis
  • Pemphigoid
  • Pemphigus
  • Polymyositis
  • Renal transplant rejection
  • Stiff person syndrome

Medicare may cover IVIG for the following diseases on a case-by-case basis:

  • Autoimmune hemolytic anemias
  • Hereditary peripheral neuropathy
  • Idiopathic neuropathy
  • Immune neutropenia
  • Inclusion body myositis
  • Livedoid vasculitis
  • Systemic lupus erythematosus