Healthcare Industry News: immune globulin
News Release - August 22, 2007
Baxter to Launch GARDian(TM), a Groundbreaking Initiative That Helps Provide Continued Access to GAMMAGARD for Current Patients
Program will build on other successful GAMMAGARD LIQUID and GAMMAGARD S/D [immune globulin Intravenous (Human)] patient programs pioneered by BaxterDEERFIELD, Ill., Aug. 22 (HSMN NewsFeed) -- Baxter International Inc. (NYSE: BAX ) today announced that it will launch GARDian, an innovative program that helps provide continued access for patients relying on GAMMAGARD LIQUID and GAMMAGARD S/D [immune globulin Intravenous (Human)] (IGIV). IGIV products like GAMMAGARD LIQUID and GAMMAGARD S/D are immunoglobulin (IgG) replacement therapies containing broad-spectrum immunoglobulins and are indicated for patients with primary immunodeficiency. 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.
GARDian is viewed as a logical extension of other successful patient- centric programs pioneered by Baxter. The hallmark of each of these programs is continued access to GAMMAGARD LIQUID and GAMMAGARD S/D. They include:
-- GAMMAssist -- An innovative program that allows eligible users of GAMMAGARD to continue to receive their immunoglobulin therapy in the event of a lapse in insurance.
-- Low IgA/Brand Intolerance Program -- A program providing patient access to GAMMAGARD S/D selected for its lower content of certain immunoglobulins called IgA, for certain patients experiencing adverse reactions from other IGIV therapies.
-- GAMMAGARD LIQUID and GAMMAGARD S/D Portability - Launched in late 2006, this program is designed to provide hospitals with continued access to GAMMAGARD irrespective of changes to their group purchasing organization affiliation.
Patient organizations welcomed the announcement of Baxter's newest patient access innovation. "Access to the IGIV product prescribed by their physician is extremely important for PI patients," said Marcia Boyle, founder and president of the Immune Deficiency Foundation, a national nonprofit patient organization dedicated to improving the diagnosis and treatment of primary immunodeficiency diseases through research, education and advocacy. "Baxter's program will be extremely helpful to PI patients by reassuring that they will not have to change from their product of choice." Noting the success of Baxter's other patient centric initiatives, Ms. Boyle added, "We would love to see such a program developed for all of the patients in our community who use GAMMAGARD LIQUID and GAMMAGARD S/D."
"Baxter has been a pioneer in advancing the science of IGIV, and its intent to establish a program that maintains continuity in IGIV therapy at the patient level is an important innovation in the industry -- one that is sure to be embraced by PID patients who use GAMMAGARD LIQUID and GAMMAGARD S/D," added Fred Modell, co-founder of the Jeffrey Modell Foundation, a national nonprofit organization dedicated to early and precise diagnosis, meaningful treatment and ultimately cures of PID.
Baxter's GARDian Program
Baxter plans to launch a pilot of GARDian in early 2008. The pilot initiative and the ensuing program will be open to current patients in the United States that routinely use the product as prescribed by a physician. Using a simple, voluntary enrollment process administered through patients' healthcare providers, enrollees will have the comfort that GAMMAGARD LIQUID and GAMMAGARD S/D is available to them even if they experience changes involving their providers or site of care. A third party vendor will manage the program, and Baxter will not have access to patient data.
Enrollment in this program will be voluntary and will not automatically preclude those patients not participating in the program from accessing GAMMAGARD LIQUID and GAMMAGARD S/D. Baxter will continue to work closely with patient organizations and key thought leaders from different clinical specialties that prescribe IGIV therapy to launch the program. Patients not enrolling in the voluntary GARDian program will still be eligible for other GAMMAGARD patient programs (e.g. GAMMAssist and the Low IgA/Brand Intolerance Program and product Portability programs).
"Baxter has a long, proud history of advancing the science of IGIV therapy and serving the patients who rely on our IGIV therapies," said Larry Guiheen, president, Baxter Biopharmaceuticals, North America. "Baxter is committed to providing continued access to their therapy of choice for our patients. The GARDian program represents our continued commitment to that goal."
Patients and physicians can sign up to receive more information about the GARDian program at http://www.immunedisease.com.
About GAMMAGARD LIQUID 10%
GAMMAGARD LIQUID is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
About GAMMAGARD S/D
GAMMAGARD S/D is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
GAMMAGARD S/D must not be used in patients with selective IgA deficiency (IgA, 0.05 g/L) where the IgA deficiency is the only abnormality of concern.
About GAMMAGARD S/D with IgA < 1 microgram/mL in a 5% solution
GAMMAGARD S/D is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
GAMMAGARD S/D must not be used in patients with selective IgA deficiency (IgA < 0.05 g/L) where the IgA deficiency is the only abnormality of concern.
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. For many people with primary immunodeficiency, the cause is a lack of antibodies. IGIV 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
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.
immune globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Glycine, an amino acid, is used as a stabilizer. GAMMAGARD LIQUID does not contain sucrose.
GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Components used in the packaging of this product are latex-free.
Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.
IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.
Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.
Various mild and moderate reactions, such as headache, fever, fatigue, chills, flushing, dizziness, urticaria, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, muscle cramps, and changes in blood pressure may occur with infusions of immune globulin Intravenous (Human).
GAMMAGARD S/D
Patients may experience severe hypersensitivity reactions or anaphylaxis in the setting of detectable IgA levels following infusion of GAMMAGARD S/D.
immune globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. GAMMAGARD S/D does not contain sucrose.
GAMMAGARD S/D is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.
Certain components used in the packaging of GAMMAGARD S/D contain natural rubber latex.
IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.
Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.
Various minor reactions, such as mild to moderate hypotension, headache, fatigue, chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight elevation of blood pressure, nausea and vomiting, may occasionally occur.
GAMMAGARD S/D with IgA < 1 microgram/mL in a 5% solution
Patients may experience severe hypersensitivity reactions or anaphylaxis in the setting of detectable IgA levels following infusion of GAMMAGARD S/D.
immune globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number.
GAMMAGARD S/D does not contain sucrose.
GAMMAGARD S/D, IgA <1 microgram/mL, has a lower IgA concentration than GAMMAGARD S/D which has a concentration of 1 to 2.2 microgram/mL. IGIV preparations depleted of IgA (0.4 to 2.9 microgram/mL) were shown to be better tolerated by a limited number of patients who reacted to IGIV preparations with higher IgA concentrations. However, the concentration of IgA that will not provoke a reaction is not known, and therefore all IGIV preparations carry the risk of inducing an anaphylactic reaction to IgA. In such instances, a risk of anaphylaxis may exist despite the fact that GAMMAGARD S/D, IgA <1 microgram/mL, contains trace amounts of IgA.
GAMMAGARD S/D is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.
Certain components used in the packaging of GAMMAGARD S/D contain natural rubber latex.
IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.
Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.
Various minor reactions, such as mild to moderate hypotension, headache, fatigue, chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight elevation of blood pressure, nausea and vomiting may occasionally occur.
The potential risks and benefits of IGIV should be weighed against those of alternative therapies for all patients for whom IGIV administration is being considered.
For full prescribing information for GAMMAGARD LIQUID, GAMMAGARD S/D and GAMMAGARD S/D with IgA less than 1 microgram/mL in a 5% solution please go to: http://www.baxter.com/products/biopharmaceuticals/downloads/gammagard_us_pi.pd f (To link to this website, please copy and paste URL in Internet browser) http://www.baxter.com/products/biopharmaceuticals/downloads/gamliquid_PI.pdf http://www.immunedisease.com/US/pdfs/gammagardsd_iga.pdf
About Baxter
Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other conditions. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
Source: Baxter
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