The human immune system serves as a defense mechanism, protecting the body from many potentially damaging substances, such as cancer cells, blood or tissues from another person, microorganisms, or toxins. In individuals with immune deficiency disorders, their immune system is absent or is functioning incorrectly.
Immune disorders can be inborn (where the individual is born with a malfunctioning immune system), or be the result of a virus or chemotherapy. There are a wide variety of immunodeficiency disorders that affect millions of men, women, and children worldwide, and there are a wide variety of treatments.
Immune globulin intravenous (human) therapies (IGIVs) can vary significantly since they are made using different production processes. Although high biological activity is the primary objective in IGIV manufacturing, these processes result in varying product features that may affect biological activity and ultimately the efficacy of the IGIV.
The products discussed herein may have different product labeling in different countries. For information about Talecris Biotherapeutics' immunology product, including full prescribing information, please select your country of residence:
Important Safety Information
Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated for the treatment of primary humoral immunodeficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP). Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human).
Immune Globulin Intravenous (Human) (IGIV) 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 [Transfusion-Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk for thrombotic events may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.
Gamunex is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.
Please speak to your doctor and refer to the Gamunex Prescribing Information (PDF) for details.
You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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