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CSL Behring Receives FDA Approval of RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
Date:1/16/2009

each candidate undergoes a series of health checks, including a family history. Donated plasma is subjected to a series of serological tests that go beyond regulatory requirements. Before fractionation, the plasma pool is further tested by nucleic acid testing for viral markers to ensure the maximum possible level of safety for patients. Additionally, virus inactivation and removal occur during the manufacturing process through heat treatment and precipitation steps.

About RiaSTAP

RiaSTAP is a purified fibrinogen concentrate indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. RiaSTAP is not indicated for dysfibrinogenemia. RiaSTAP is contraindicated in individuals who have had severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP or its components.

Physicians should monitor patients for early signs of allergic or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving RiaSTAP. Physicians should weigh the benefits of administration versus the risks of thrombosis.

RiaSTAP is made from pooled human plasma. Products made from human plasma may contain infectious agents (e.g., viruses and theoretically the Creutzfeldt-Jakob disease agent (CJD) that can cause disease). The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by a process demonstrated to inactivate and/or remove certain viruses during manufacturing. Despite these measures, such products may still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products.

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