 You have the choice.
Gamunex®, a prescription therapy, was the first next-generation IGIV product in more than a decade.
Gamunex® represents new hope for current and future generations of IGIV users because it was designed with your needs in mind.
A gentle process means a better product.
In seeking to create an advanced next-generation IGIV product, we quickly discovered that how an IGIV product is made determines the quality of the product.
Some IGIV production processes are based on decades-old technologies in which every necessary modification was simply added onto the existing process over the years. The result is a retrofitted patchwork that was far from ideal and did not provide the technological flexibility for the improvements we had in mind. When we committed to develop Gamunex®, experts in pathogen safety and process engineering began with a clean sheet-and a $250 million investment in a brand new production facility, the first of its kind to be dedicated solely to the production of IGIV.
An innovative purification process using caprylate/chromatography, which improves product purity and process reliability, resulted in the first completely new IGIV product in over a decade. Caprylate, a naturally occurring fatty acid, is proven to safely, effectively and rapidly inactivate viruses. This provides peace of mind for patients concerned about the safety of the products they are receiving. Caprylate also is a gentle alternative to the traditional solvent-detergent (SD) viral inactivation method, and this gentleness helps to preserve the biological activity of the fragile immunoglobulin (antibody) proteins. Preserving biological activity is the cornerstone of a highly effective, well-tolerated product.
The Gamunex® production process also eliminates the need for additives, such as sucrose as a protein stabilizer. Sucrose has been associated with severe adverse reactions, such as renal dysfunction and acute renal failure in other IGIV products. Adverse reactions can become a barrier to use, which prevents some individuals from receiving the lifesaving benefits of IGIV.
Gamunex® is a 10% ready-to-use liquid product, that reduces preparation time. Gamunex®, a highly concentrated and high purity formulation, allows for lower volume infusions and a faster infusion, freeing up time for patients and the healthcare providers who care for them.
For full Prescribing Information click here.
Gamunex®: Making the difference
You have the choice in IGIV therapy.
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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.
Gamunex is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.
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