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Integrated Analysis Demonstrates Alpha(1)-Augmentation Therapy Significantly Reduces Loss of Lung Tissue in Patients with AAT-deficiency-related Emphysema
Date:11/15/2010

s of the alpha-1 protein can result in emphysema. The active protein in PROLASTIN-C increases or "augments" protein levels in AAT deficient patients. In the U.S., PROLASTIN-C has replaced PROLASTIN, the leading augmentation therapy in North America for more than 20 years.  

Important Safety Information for PROLASTIN-C and PROLASTIN

The effect of augmentation therapy with any Alpha(1)-proteinase inhibitor (A1PI) 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 and PROLASTIN 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 observed at a rate of greater than or equal to 1% in subjects receiving PROLASTIN-C were chills, malaise, headache, rash, hot flush, and pruritus.  The most serious adverse reaction observed during clinical studies with PROLASTIN-C was a rash on the abdomen and extremities in 1 subject. In clinical studies with PROLASTIN, reactions were observed in 1.16% of infusions, the most common being fever, lightheadedness and dizziness.

Both PROLASTIN-C and PROLASTIN are 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.  There is also the possibility that unknown infectious agents may be present in such products.

In the US, for additional information on PROLASTIN-C, please see full prescribing information at www.PROLASTIN.com.  You are encouraged to report negative
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SOURCE Talecris Biotherapeutics
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