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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Immune Globulin Intravenous (IGIV) Indications

List is in Order by Manufacturer

Product
Manufacturer
Indications
Gammagard Liquid
Baxter Healthcare Corporation
  • Treatment of primary immunodeficiency disorders associated with defects in humoral immunity
Gammagard S/D
Baxter Healthcare Corporation
  • Prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia.
  • Prevention of coronary artery aneurysms associated with Kawasaki Syndrome.
  • To induce rapid rise in platelet count when needed to prevent and/or to control bleeding in a patient with Idiopathic Thrombocytopenic Purpura.
Iveegam E/N
Baxter Healthcare Corporation
  • Replacement therapy in patients with primary immunodeficiency syndromes (PIDD)
  • Kawasaki syndrome
Polygam S/D
Baxter Healthcare Corporation
  • Primary Humoral Immunodeficiency
  • Immune Mediated Thrombocytopenia
Carimune NF
CSL Behring AG
  • Primary Humoral Immunodeficiency
  • Immune Thrombocytopenic Purpura
Gammar-P I.V.
CSL Behring AG
  • Primary Humoral Immunodeficiency
Panglobulin NF
CSL Behring AG
  • Primary Humoral Immunodeficiency
  • Immune Thrombocytopenic Purpura
Privigen
CSL Behring AG
  • Primary Immunodeficiency
  • Chronic Immune Thrombocytopenic Purpura

Flebogamma DIF 5%

Grifols
  • Replacement therapy in primary (inherited) humoral immune deficiency disorders
Venoglobulin-S
Grifols Biologicals, Inc.
  • Primary Humoral Immunodeficiency
  • Immune Mediated Thrombocytopenia
  • Kawasaki syndrome
Octagam
Octapharma
  • Treatment of Primary Humoral Immunodeficiency
Gamimune N
Talecris Biotherapeutics, Inc.
  • Primary Humoral Immunodeficiency
  • Immune Mediated Thrombocytopenia
  • Bone marrow transplantation
  • Pediatric HIV-1
Gamunex
Talecris Biotherapeutics, Inc
  • Primary Humoral Immunodeficiency
  • Idiopathic Thrombocytopenic Purpura
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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