DEERFIELD, Ill., Sept. 26 /PRNewswire-FirstCall/ -- Baxter Healthcare
Corporation announced today that GAMMAGARD LIQUID(TM) [Immune Globulin
Intravenous (Human)] (IVIG) 10% Solution is now available to patients in the
United States for the treatment of primary immunodeficiencies. Primary
immunodeficiency is a group of genetic disorders in which the immune system
fails to produce adequate amounts of antibodies, thereby predisposing
individuals to increased risk of infection.
"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 < 0.05 g/L) may develop anti-IgA
antibodies that can result in a severe anaphylactic reaction. Such patients
should only receive intravenous immune globulin with utmost caution and in a
setting where supportive care is available for treating life-threatening
reactions.
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.
About Baxter
Baxter Healthcare Corporation is the principal domestic operating
subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International
Inc., through its subsidiaries, assists healthcare professionals and their
patients with treatment of complex medical conditions, including cancer,
hemophilia, immune disorders, kidney disease and trauma. The company applies
its expertise in medical devices, pharmaceuticals and biotechnology to make a
meaningful difference in patients' lives.
For more information about Baxter, including GAMMAGARD LIQUID full
prescribing information, please visit http://www.baxter.com .
SOURCE Baxter Healthcare Corporation
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