• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Immune Globulin Products (Human) intravenous, subcutaneous and intramuscular

Detailed View: Safety Labeling Changes Approved By FDA Center for Biologics Evaluation and Research (CBER) – June 2013

 

Immune Globulin Intravenous (Human)
  • Bivigam/Immune Globulin Intravenous, 10% Liquid
  • Carimune NF, Nanofiltered/ Immune Globulin Intravenous
  • Flebogamma DIF 5%/Immune Globulin Intravenous
  • Flebogamma DIF 10%/ Immune Globulin Intravenous
  • Gammagard Liquid/Immune Globulin Intravenous, 10% Solution (also used subcutaneous)
  • Gammagard S/D/ Immune Globulin Intravenous
  • Gammaplex/ Immune Globulin Intravenous
  • Gamunex-C/ Immune Globulin Intravenous, 10%, Caprylate/Chromatography Purified (also used subcutaneous)
  • Octagam/ Immune Globulin Intravenous, 5%
  • Privigen/ Immune Globulin Intravenous, 10% Liquid
Immune Globulin Subcutaneous (Human)
  • Hizentra/ Immune Globulin Subcutaneous, 20% Liquid
  • Vivaglobin/ Immune Globulin Subcutaneous
Immune Globulin Intramuscular (Human)
  • GamaSTAN S/D/Immune Globulin

 

Summary View

 

BOXED WARNING

  • FDA has analyzed recent data that has strengthened the association between the use of intravenous, subcutaneous and intramuscular human immune globulin products and the risk of thrombosis. Additional caution regarding the use of these products is warranted.
  • FDA is requiring manufacturers to add information on thrombosis to the current boxed warning in the labels of all intravenous human immune globulin products and to add a boxed warning to the labels of all subcutaneous and intramuscular human immune globulin products to highlight the risk of thrombosis and to add information on its mitigation.