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Talecris Biotherapeutics Enrolls Patients in Clinical Trial Evaluating Two Doses of PROLASTIN®-C
Date:12/9/2010

"augments" protein levels in AAT deficient patients.   In the U.S. and Canada, PROLASTIN-C has replaced PROLASTIN, the leading augmentation therapy in North America for more than 20 years.  

Important Safety Information for PROLASTIN-C

The effect of augmentation therapy with any alpha(1)-proteinase inhibitor on pulmonary exacerbations and on the progression of emphysema in alpha(1)-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.

PROLASTIN-C may contain trace amounts of IgA.  Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.  PROLASTIN-C is contraindicated in patients with antibodies against IgA.

The most common drug related adverse reactions during clinical trials in greater than or equal to 1% of subjects were chills, malaise, headache, rash, hot flush, and pruritus.  The most serious adverse reaction observed during the clinical studies with PROLASTIN-C was an abdominal and extremity rash in one subject.

PROLASTIN-C is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

In the US, for additional information on PROLASTIN-C, please see full prescribing information at www.PROLASTIN.com.  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.

About Alpha(1)-Antitrypsin Deficiency

Alpha(1)-antitrypsin deficiency, also known as AAT deficiency or Alpha-1, is an inherited disorder that causes significant reduction in the naturally occurring protein alpha(1)-proteina
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SOURCE Talecris Biotherapeutics, Inc.
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