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Talecris Commitment
First and foremost, Talecris is committed to the patient communities who rely on our products and to the healthcare professionals who treat them.

From donor screening and plasma testing to our innovative manufacturing processes, Talecris continues to work toward our vision of being the recognized leader in developing and providing vital protein therapeutics.

Plasma collection

Talecris Plasma Resources, Inc. (TPR) is a network of plasma collection centers and a wholly owned subsidiary of Talecris Biotherapeutics, Inc. With TPR, Talecris can further ensure the reliable supply and safety of our products from "arm-to-arm" — from the arms of plasma donors to the arms of people who rely on our life-enhancing and life-saving plasma therapeutics manufactured from this plasma.

Talecris continues to expand its plasma collection capability by opening new plasma collection centers to meet the growing demand for plasma.

For more information about Talecris Plasma Resources, visit http://www.talecrisplasma.com/.

The caprylate/chromatography purification process

When we decided to develop Gamunex to build on the excellence of Gamimune® N, 10% (Immune Globulin Intravenous [Human]), we wanted a manufacturing transformation that would produce the best IGIV product we could make. So we introduced a new purification process, caprylate/chromatography, which could deliver an enhanced product.

    This unique process improves product purity while effectively and rapidly inactivating enveloped viruses
 
    This process better protects the fragile IgG protein compared to harsher purification methods*


We also realized that this new manufacturing paradigm would require complete dedication of resources. So we decided to build a new IGIV manufacturing plant. Talecris' primary manufacturing facility in Clayton, NC, USA, employs state-of-the-art processes for reliable, safe production of biological products. Through recent investments totaling more than $250 million, Talecris is dedicated to keeping the Clayton facility at the cutting edge of protein therapeutics production.

A history of success

Over 100 million grams of liquid IGIV have been distributed globally by the makers of Gamunex over the past 25 years, without a single confirmed case of virus transmission.†

*   Gamunex caprylate/chromatography process vs the Gamimune N, 10% solvent/detergent process.
 
†   Includes Gamimune (Immune Globulin Intravenous [Human]), Gamimune N, 10%, and Gamunex.


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 Gamunex Prescribing Information for full 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.



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