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FDA Approves Revised Alphanate® Labeling to Include Reduced Infectivity of an Experimental Model Agent for vCJD
Date:3/4/2011

gery, in whom desmopressin (DDAVP®) is either ineffective or contraindicated.  Antihemophilic factor potency (Factor VIII:C activity) is expressed in International Units (IU) on the product label.  Additionally, each vial of Alphanate® also contains VWF:RCo activity in IU for the treatment of VWD.

Alphanate® is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.  Anaphylaxis and severe hypersensitivity reactions are possible.  Development of activity-neutralizing antibodies has been detected in patients receiving FVIII containing products.  Development of alloantibodies to VWF in Type 3 VWD patients has been occasionally reported in the literature.   Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWD patients, especially in the setting of known risk factors.  Intravascular hemolysis may be associated with infusion of massive doses of AHF/VWF Complex (Human).  Rapid administration (>10mL/minute) of a FVIII concentrate may result in vasomotor reactions.  The most frequent adverse events reported with Alphanate® in > 5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain and fatigue.

Because Alphanate is made from pooled human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent. Stringent procedures designed to reduce the risk of adventitious  agent transmission have been employed in the manufacture of this product, from the screening of plasma donors and the collection and testing of plasma, through the application of viral elimination/reduction steps such as solvent detergent and heat treatment in the manufacturing process. Despite these measures, such products can still potentially transmit d
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