Sugar content
Gamunex® is a completely sugar-free formulation.
To stabilize the product, various sugars are added to some IGIV preparations currently available in the U.S. Acute renal failure and renal insufficiency have been associated with the use of IGIV products, especially those that contain sugar as a stabilizer. Sugar content should also be a consideration for diabetic patients.
Sodium (salt content)
Gamunex® contains trace amounts of sodium.
Sodium content varies widely amongst IGIVs and has been associated with adverse events that may include thromboembolic complications.
Concentrating lyophilized (freeze-dried powder) products to decrease volume or infusion time may significantly increase osmolality and sodium concentration.
Purity
Gamunex® has been optimized to increase the purity of the final formulation.
Compared to its predecessor product, the IgA content of Gamunex® was reduced threefold.
A reduction and elimination of protein impurities, like IgA, during the manufacturing process helps to optimize product purity. This means that the better a product's purification process works, the less impurities a product passes onto patients. Protein impurities can be associated with side effects in some patients.
10% formulation
A 10% formulation reduces the volume that is infused by 50% compared to a 5% formulation. High-infusion volumes may increase risk for infants or patients with cardiac impairment or renal dysfunction, so the goal is to keep the infusion volume as low as possible.
It also takes only half of the time to infuse a 10% vs a 5% concentration, which gets patients out of the infusion suite and on with their life faster.
Gamunex is prepared as a volume-saving 10% formulation.
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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