- The clinical trials for Gamunex® demonstrated that Gamunex® was at least as effective as Gamimune® N, 10%, Immune Globulin Intravenous (Human), and also showed very surprising results. In particular, the annual rate of validated infections in PI was significantly reduced with Gamunex, which suggests that the biological activity has been better preserved.
- The processing time for Gamunex® is much shorter than for other IGIVs because all the production elements have been integrated in order to create a more efficient process. This revolutionary process assures that the product stays in solution at all times, minimizing the exposure of the fragile immunoglobulins to harsh production elements, such as heat or chemicals.
- The Gamunex® production process uses caprylate, a plant-derived, naturally occurring fatty acid. The caprylate purification process treats the fragile immunoglobulins much more gently to better preserve their effectiveness.
According to a 2002 patient survey conducted by the Immune Deficiency Foundation, Treatment Experiences and Preferences of Patients with Primary Immune Deficiency Diseases, some patients reported that the effects of their IGIV wear off, often before they receive their next infusion.
This may in part be due to the differences in the production processes of IGIV products. How an IGIV is produced is an important factor that determines how well the biological activity of the fragile immunoglobulins is preserved. This suggests that different production processes may lead to differences in IGIV products-and this can affect how well your IGIV works for you.
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.
|
