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Immune Globulin Subcutaneous News

Shire Announces FDA Approval of Cuvitru [immune globulin subcutaneous (human)] for Primary Immunodeficiency

Posted 16 Sep 2016 by Drugs.com

Lexington, Mass. – September 14, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the United States Food and Drug Administration (FDA) has granted approval for Cuvitru [Immune Globulin Subcutaneous (Human), 20% Solution] in adult and pediatric patients two years of age and older. Cuvitru is a treatment for patients with primary immunodeficiency (PI), a group of more than 300 genetic disorders in which part of the body’s immune system is missing or functions improperly; it affects up to six million people worldwide. With the approval of Cuvitru, Shire now has the broadest portfolio of intravenous and subcutaneous immunoglobulin (IG) products, including the only once-a-month subcutaneous treatment option. Cuvitru is the only 20% subcutaneous IG treatment option without proline and with the ability to infuse up to 60 mL (12 grams) per site and 60 mL per hour, per site as tolerat ... Read more

Related support groups: Primary Immunodeficiency Syndrome, Immunodeficiency, Immune Globulin Subcutaneous, Cuvitru

Talecris Biotherapeutics Receives FDA Approval for Gamunex-C

Posted 17 Oct 2010 by Drugs.com

RESEARCH TRIANGLE PARK , N.C., Oct. 14 /PRNewswire-FirstCall/ – Talecris Biotherapeutics (Nasdaq: TLCR) announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI). The newly approved Gamunex-C provides both the intravenous route of administration and a new subcutaneous route of administration. The intravenous delivery mode is approved to treat PI, chronic inflammatory demyelinating polyneuropathy (CIDP), and idiopathic thrombocytopenic purpura (ITP). The subcutaneous mode is approved to treat only PI. The difference between Gamunex and Gamunex-C is the labeling and packaging information. Gamunex-C labeling describes both the intravenous and subcutaneous routes of administration, whereas Gamunex labeling ... Read more

Related support groups: Primary Immunodeficiency Syndrome, Gamunex, Immune Globulin Subcutaneous

CSL Behring Receives FDA Approval of Hizentra, First 20 Percent Subcutaneous Immunoglobulin Therapy

Posted 10 Mar 2010 by Drugs.com

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Mar 4, 2010 - CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (PI). A once weekly immunoglobulin (Ig) replacement therapy, Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body. Primary immunodeficiencies constitute a group of disorders, usually genetic, that cause a malfunction in all or part of the immune system, thereby rendering the patient unable to fight off infections caused by everyday germs. Hizentra is the first 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S. by the FDA. This high-concentration product is stabilized with L-proline, a naturally-occurring amino acid. ... Read more

Related support groups: Immune Globulin Subcutaneous

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Further Information

Related Condition Support Groups

Primary Immunodeficiency Syndrome

Related Drug Support Groups

Hizentra, Vivaglobin, Cuvitru

Immune Globulin Subcutaneous Patient Information at Drugs.com