General Conditions of Use
Access to and use of this Web site are subject to the following conditions. Please
do not use this Web site unless you agree with these conditions. This Web site has
been developed by Talecris Biotherapeutics, Inc. (hereinafter to be referred to
as TALECRIS) and is administrated by the same. We reserve the right to discontinue
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note any changes or amendments that may have been made.
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TALECRIS has compiled the detailed information provided on this Web site from internal
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advice—particularly our safety datasheets and technical specifications—
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nor third parties involved in the writing, production or transmission of this Web
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accept any responsibility for the availability or the contents of such Web sites
or any liability for damage or injury resulting from the use of such contents, of
whatever form. Links to other Web sites are provided to Web site users merely for
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techniques and expertise contained therein, for any purpose, such as the development,
production and/or marketing of products or services and to reproduce such information
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International users
This Web site is checked, operated and updated by Talecris Biotherapeutics, Inc.
at Research Triangle Park, North Carolina (USA). TALECRIS gives no guarantee that
the details presented on this Web site are also correct in places outside the USA,
and, in particular, that products and services will be available with the same appearance,
in the same sizes or on the same conditions. Should you call up this Web site from
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Products mentioned on this Web site may come in different packaging, in different
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Site with login: access rights
Please note that you are obliged to protect your access rights from unauthorized
third-party use and that you must ensure that they cannot be used by others without
your authorization. You must notify TALECRIS immediately if you learn that security
has been violated in respect of any details available on the TALECRIS Web site or
if unauthorized persons have obtained your access rights or if you have found indications
that such access might become possible.
Updated October 2006
Important Safety Information for GAMUNEX
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).
Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. 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.
Gamunex is contraindicated in individuals with acute severe hypersensitivity reactions to Immune Globulin (Human). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity.
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. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
In clinical studies, the most common adverse reactions with Gamunex were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP). The most serious adverse reactions were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).
Please see accompanying GAMUNEX full Prescribing Information for complete prescribing details.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.