Jane S. Ricciuti, RPh, MS

Disclosures

October 21, 2003

In This Article

Immune Globulin

Gamunex
(Immune Globulin Intravenous [Human], 10% by Chromatography Process)

Manufacturer: Bayer Corporation

Drug Approval Classification: Biologics License Application (Approval Date: 8/27/03)

Indication: Gamunex (immune globulin) is indicated for:

  • Primary humoral immunodeficiency (PI)

    • Gamunex is indicated as replacement therapy of PI states in which severe impairment of antibody-forming capacity has been shown, such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked immunodeficiency with hyper IgM, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

  • Idiopathic thrombocytopenic purpura (ITP)

    • Gamunex is indicated in ITP to rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.

Gamunex (Immune Globulin Intravenous [Human], 10% by Chromatography Process) Labeling

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