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  • Hepatitis A
  • Immune Globulin

What is immune globulin (IG)?

Immune globulin (IG, GamaSTAN, Grifols Therapeutics) is a sterile preparation of concentrated antibodies (i.e., immunoglobulins) made from pooled human plasma processed by cold ethanol fractionation. GamaSTAN is the only IG product licensed in the United States for the prevention of hepatitis A virus (HAV) infection. Only plasma that has tested negative for hepatitis B surface antigen, antibody to human immunodeficiency virus (HIV), and antibody to hepatitis C virus (HCV) is used to produce IG. In addition, the Food and Drug Administration requires that the process used to produce IG include a viral inactivation step or that final products test negative for HCV-RNA by polymerase chain reaction. Anti-HAV concentrations differ among IG lots and decreasing concentrations have been observed over the past 30 years, probably because of the decreasing prevalence of previous HAV infection among plasma donors. In 2017, the dosing of GamaSTAN for HAV prevention was increased to reflect this change in anti-HAV potency.

Last reviewed: June 25, 2023

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