Intravenous Immune Globulin Products
Immune globulin is made from pooled plasma collected from thousands of donors and treated to remove contaminants to ensure product safety and integrity. Containing antibodies against a broad spectrum of bacteria and viruses, immune globulin can be administered intravenously (through a vein) and is known as IVIg or subcutaneously (under the skin), known as SCIg. Subcutaneous immune globulin has two types of infusions. Most subcutaneous products are infused via weekly small doses. One product is a "facilitated" SCIg which includes a pre-infusion of hyaluronidase which allows for the skin to tolerate much larger volumes of Ig which decreases the need for weekly infusions. Immune globulin is used to treat immune deficiencies and many autoimmune disorders.
F.D.A.-approved intravenous immune globulin (IVIG) products:
Product: Asceniv™
Manufacturer: ADMA Biologics
FDA-Approved Indication: Primary Immunodeficiency Disease (PIDD)
Product: Bivigam®
Manufacturer: ADMA Biologics
FDA-Approved Indication: Primary Immunodeficiency Disease (PIDD)
Product: GAMMAGARD S/D (IGA<1 MCG/ML)
Manufacturer: Takeda
FDA-Approved Indication:
Primary Immunodeficiency Disease (PIDD), prevention of bacterial infections in Chronic Lymphocytic Leukemia (CLL), Chronic Immune Thrombocytopenic Purpura (Chronic ITP), Kawasaki Disease
Product: GAMMAGARD LIQUID
Manufacturer: Takeda
FDA-Approved Indication:
Primary Immunodeficiency Disease (PIDD), Multifocal Motor Neuropathy (MMN)
Product: GAMMAKED™
Manufacturer: Kedrion
FDA-Approved Indication:
Primary Immunodeficiency Disease (PIDD), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Immune Thrombocytopenic Purpura (ITP)
Product: Gammaplex® 5%
Manufacturer: Bio Products Laboratory
FDA-Approved Indication:
Primary Immunodeficiency Disease (PIDD), Chronic Immune Thrombocytopenic Purpura (Chronic ITP)
Product: Gammaplex® 10%
Manufacturer: Bio Products Laboratory
FDA-Approved Indication:
Primary Immunodeficiency Disease (PIDD), Chronic Immune Thrombocytopenic Purpura (Chronic ITP)
Product: Gamunex®-C
Manufacturer: Grifols
FDA-Approved Indication:
Primary Immunodeficiency Disease (PIDD), Immune Thrombocytopenic Purpura (ITP), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Product: Octagam® 5%
Manufacturer: Octapharma
FDA-Approved Indication:
Primary Immunodeficiency Disease (PIDD)
Product: Octagam® 10%
Manufacturer: Octapharma
FDA-Approved Indication:
Chronic Immune Thrombocytopenic Purpura (Chronic ITP), Dermatomyositis
Product: PANZYGA®
Manufacturer: Manufactured by Octapharma, distributed by Pfizer
FDA-Approved Indication:
Primary Immunodeficiency Disease (PIDD), Chronic Immune Thrombocytopenic Purpura (Chronic ITP), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Product: Privigen®
Manufacturer: CSL Behring
FDA-Approved Indication:
Primary Immunodeficiency Disease (PIDD), Chronic Immune Thrombocytopenic Purpura (Chronic ITP), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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