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Primary Immunodeficiency Syndrome 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

FDA Medwatch Alert: Bivigam Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall - Visible Particles Observed

Posted 8 Apr 2013 by Drugs.com

  [Posted 04/05/2013] ISSUE: During a routine annual reserve inspection, visible particles were observed in lot number 120016 (Expiration Date: March 31, 2014) of Bivigam Immune Globulin Intravenous (Human), 10% Liquid. Biotest is voluntarily recalling this lot from the market. Inspections of other lots of product have not shown the presence of visible particles. BACKGROUND: Bivigam is indicated for the treatment of patients with primary humoral immunodeficiency (PI). RECOMMENDATION: Consignees are asked to examine stocks immediately to determine if you have any of Lot 120016 on hand. If so, discontinue distributing the lot and promptly return all vials to Biotest’s Boca Raton, Florida facility. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Re ... Read more

Related support groups: Primary Immunodeficiency Syndrome, Bivigam

FDA Approves Biotest's Bivigam, an Intravenous Immune Globulin (Human), 10% Liquid

Posted 29 Dec 2012 by Drugs.com

DREIEICH, Germany and BOCA RATON, Fla., Dec. 20, 2012 /PRNewswire/ – Biotest AG announced today that Biotest Pharmaceuticals Corporation received approval for Bivigam for the treatment of patients with Primary Humoral Immunodeficiency (PI) from the U.S. Food and Drug Administration (FDA). Bivigam is the first polyspecific intravenous immune globulin manufactured in the U.S. by Biotest Pharmaceuticals Corporation (BPC) at its Boca Raton, Florida facility. This product is being produced for patients in the United States, and the company plans to begin commercial shipments shortly. Prof. Dr. Gregor Schulz , CEO of Biotest AG, said: "Biotest has made a significant commitment in the U.S. to bring a new immune globulin to individuals with primary immunodeficiency. We have invested over $50 million to create a state-of-the-art facility and have expanded our U.S. capabilities from plasma ... Read more

Related support groups: Primary Immunodeficiency Syndrome, Immune Globulin Intravenous

Baxter Announces FDA Approval of Subcutaneous Route of Administration for Gammagard Liquid for Patients with Primary Immunodeficiency

Posted 25 Jul 2011 by Drugs.com

DEERFIELD, Ill.--(BUSINESS WIRE)--Jul 25, 2011 - Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous administration of Gammagard Liquid 10% [Immune Globulin Infusion (Human)] for patients with primary immunodeficiency (PI). The approval of this new route of administration will allow physicians and PI patients to work together to determine which route of administration of Gammagard Liquid is most appropriate. Subcutaneous use of Gammagard Liquid allows patients to self-administer their therapy at home on a weekly basis. "The FDA approval of a subcutaneous route of administration for Gammagard Liquid offers PI patients the option to administer Gammagard Liquid either intravenously or subcutaneously, depending on their individual needs," said Richard Schiff, M.D., Ph.D., medical director for Baxter's gammaglobulin trials. ... Read more

Related support groups: Primary Immunodeficiency Syndrome, Gammagard, Gammagard S/D

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

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Immunodeficiency

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Hizentra, Gammagard, Gamunex, Privigen, Vivaglobin, immune globulin intravenous, immune globulin subcutaneous, Sandoglobulin, Carimune, view more... Gamunex-C, Hyqvia, Cuvitru, Bivigam, Gammaked, Gamimune, Gammar IV, Carimune NF, Gammaplex, Iveegam En, Panglobulin NF, Gammagard S / D, Flebogamma, hyaluronidase / immune globulin, immune globulin intravenous and subcutaneous, Venoglobulin-S 5%, Venoglobulin-S 10%, Gamimune N 10%, Panglobulin, Gamimune N 5%, Polygam S / D, Gammar-P IV, Octagam