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Talecris Biotherapeutics Receives FDA Approval for Gamunex®-C
Date:10/14/2010

er infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation.

In clinical studies, the most common adverse reactions with Gamunex-C were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria with intravenous use (in PI) and infusion site reactions, headache, fatigue, arthralgia and pyrexia with subcutaneous use (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP).  

The most serious adverse reactions in clinical studies 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).

Due to a potential risk of hematoma formation, Gamunex-C should not be administered subcutaneously in patients with ITP.  Subcutaneous administration of Gamunex-C in patients with ITP has not been studied.

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.

For additional information about Gamunex, please see www.gamunex.com for Full Prescribing Information.  The package insert is currently being revised to incorporate information regarding subcutaneous administration for treatment of primary immunodeficiency.

Cautionary statement regarding forward-looking statements

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements include, but are no
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SOURCE Talecris Biotherapeutics, Inc.
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