Gamunex® is a bold, new future for IGIV production.
At Talecris, we are continually challenging ourselves to improve upon all our products, and Gamunex® was no exception.
We know that IGIV is a therapy critical to patients' lives. However, we also know that as we've continuously improved IGIV quality over the last two decades, we stretched the old technology to its limits. So, as we began the development of a new generation of IGIV product, we concluded the only way to continue improving was to go back to the drawing board.
We took our many years of experience and our knowledge of unmet medical needs and used that expertise to lead the development of a new manufacturing technology for Gamunex®.
It's not just a promise. It's built into the process.
Gamunex® was designed from scratch to address the needs of both patients and caregivers in efficacy, tolerability, safety, and convenience. But we didn't stop there.
Gamunex® is manufactured in a unique, 100% dedicated facility that introduces an innovative and visionary purification process never before seen. This new purification process helps ensure that a consistent and reliable supply is available when it's needed.
The process doesn't just make the product. It is the product.
Over the years, decades-old purification processes have been modified to meet today's high standards. As a result, different IGIV production processes have evolved. Different manufacturing processes create different features for each IGIV product.
When we decided to build on the excellence of Gamimune® N (immune globulin intravenous [human], 10%), we wanted a manufacturing transformation that would produce the best IGIV product we could make. So we introduced a new purification process called Caprylate/Chromatography — one that could actually deliver an enhanced product and more of it.
We also realized that this new manufacturing paradigm would require complete dedication of resources. So we decided to build a new IGIV manufacturing plant — literally from the ground up.
Gamunex® is the result of a completely new manufacturing process — a totally new IGIV formulation in a dedicated facility that is the world's largest of its kind. And we believe this revolutionary process and product will provide lifesaving therapies to patients around the globe.
Talecris is building the future based on our solid history.
Gamunex® is created by a revolutionary new manufacturing process that makes the difference… New caprylate/chromatography process
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Optimizes product purity and reduces manipulation of fragile immunoglobulins |
The largest ever licensure-relevant trial program
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Brings unprecedented evidence for an IGIV's clinical efficacy
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Gamunex® is proven to be at least as effective as Gamimune® N, 10%, immune globulin intravenous (human), 10%, with additional evidence for enhanced efficacy |
Proven anti-infective and immunomodulatory efficacy
Clinical proof of tolerability
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No evidence of thrombosis or renal impairment in clinical trial program |
For more information about Talecris' Gamunex® click here.
Primary Immunodeficiency Diseases (PI)
Primary immune deficiency is a disorder in which part of the body's immune system is missing or does not function properly. It is caused by congenital defects in the immune system.
The variety of primary immune deficiencies includes X-linked Agammaglobulinemia (Bruton's Disease), Common Variable Immune Deficiency (also called Hypogammaglobulinemia), Selective IgA Deficiency, and Severe Combined Immune Deficiency (boy-in-the-bubble disease).
Untreated primary immune deficiencies can be characterized by frequent life-threatening infections and debilitating illnesses. In the past, many patients did not live beyond childhood. Advances in medical treatment including therapies, such as intravenous gamma globulin infusion, antibiotic therapies, or bone marrow transplantation, now allow patients to lead fairly normal lives.
Important Safety Information
Gamunex®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated as replacement therapy of primary humoral immunodeficiency disease (PI) and as immunomodulatory therapy for idiopathic thrombocytopenic purpura (ITP). Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human).
Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians.
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. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.
There have been reports of noncardiogenic pulmonary edema, rare reports of hemolytic anemia, and very rare reports of aseptic meningitis in patients administered with IGIV. 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.
As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.
Please click here for Gamunex full prescribing information (PDF).
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