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Antihemophilic Factor/ Von Willebrand Factor Complex (Human) contains Antihemophilic Factor (FVIII) and von Willebrand Factor (VWF), constituents of normal plasma, which are required for clotting. The administration of Alphanate temporarily increases the plasma level of FVIII, thus minimizing the hazard of hemorrhage in patients with hemophilia A. FVIII is an essential cofactor in activation of factor X leading to formation of thrombin and fibrin. VWF promotes platelet aggregation and platelet adhesion on damaged vascular endothelium; it also serves as a stabilizing carrier protein for the procoagulant protein FVIII.
Alphanate, (antihemophilic factor/von Willebrand factor complex), is indicated for:
Alphanate contains the labeled amount of Factor VIII expressed in International Units (IU) FVIII/vial and Willebrand.
Factor: Ristocetin Cofactor activity in IU VWF:RCo/vial.
Hemophilia A: Control and prevention of bleeding episodes
Von Willebrand Disease: Surgical and/or invasive procedure in adult and pediatric patients except Type 3 undergoing major surgery
Pediatric Use-
Geriatric Use: No human or animal data. Use only if clearly needed.
Alphanate is for intravenous use only after reconstitution. Use plastic disposable syringes. Do not refrigerate after reconstitution. Reconstituted Alphanate may be stored at room temperature (not to exceed 30° C) prior to administration, but administer intravenously within three hours.
Discard any unused contents into the appropriate safety container. Do not administer Alphanate at a rate exceeding 10 mL/minute.
Alphanate is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.
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
Pregnancy: No human or animal data. Use only if clearly needed
Labor and Delivery: No human or animal data. Use only if clearly needed
Nursing Mothers: No human or animal data. Use only if clearly needed
Risk of thromboembolic events & infections. Pregnancy.