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
|SOURCE Talecris Biotherapeutics, Inc.|
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