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Gammagard Liquid Now Available for Patients With Primary Immunodeficiency Disorders
"The launch of GAMMAGARD LIQUID is the latest step in Baxter's ongoing efforts toward advancing the science of IVIG," said Joy Amundson, president of Baxter's BioScience business. "We are proud to provide this next generation IVIG therapy to address the needs of healthcare professionals and patients with primary immunodeficiency disorders."
GAMMAGARD LIQUID offers improved convenience for healthcare professionals and patients. The therapy's ready-to-use, sterile preparation eliminates the need for reconstitution. In addition, its high concentration, compared to 5% concentrations, allows for a reduction in the length of infusion, reducing the infusion volume and saving time for both patients and healthcare professionals. It is also the first and only 10% IVIG solution with the following unique combination of features: no added sugars, no added sodium, no added preservatives and latex-free packaging.
In the U.S., GAMMAGARD LIQUID is available in five vial sizes (1g, 2.5g, 5g, 10g and 20g) and can be stored for up to nine months at room temperature within 24 months of manufacture, or for up to 36 months if kept under refrigeration. The therapy is processed from human plasma and contains a broad spectrum of IgG antibodies against bacterial and viral agents. To help ensure viral safety, three validated, independent and effective virus inactivation/removal steps have been integrated into processing and formulation, namely solvent/detergent (S/D) treatment, 35 nanometer filtration, and low pH incubation.
Baxter will continue to supply its current GAMMAGARD S/D only for use with patients who require a low Immunoglobulin A (IgA) therapy.
Outside the United States, Baxter has also submitted applications for marketing authorization to the European Medicines Agency (EMEA), Swissmedic and Health Canada's Drug Directorate.
About Primary Immunodeficiency Disorders
Primary immunodeficiency disorders encompass more than 100 diseases caused by an immune system that does not function correctly. According to the Immune Deficiency Foundation, approximately 50,000 persons in the United States have one of the primary immunodeficiency disorders. IVIG therapy can help restore IgG levels to near normal, helping the immune system function properly and prevent infections or fight them when they occur.
Important Safety Information
GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA IVIG products have been associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIG products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. GAMMAGARD LIQUID does not contain sucrose.
GAMMAGARD LIQUID is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, such as viruses, that can cause disease.
The potential risks and benefits of IVIG should be weighed against those of alternative therapies for all patients for whom IVIG administration is being considered.
Source: Baxter Healthcare Corporation