Alphanate

Alphanate, (antihemophilic factor/von Willebrand factor complex), is indicated for : Control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with Factor VIII (FVIII) deficiency due to hemophilia A. Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery.

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 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 Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL) Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician Von Willebrand Disease : Surgical and/or invasive procedure in adult and pediatric patients except Type 3 undergoing major surgery Adults : Pre-operative dose of 60 IU VWF:RCo/kg body weight; subsequent doses of 40-60 IU VWF:RCo/kg/body weight at 8-12 hour intervals post-operative as clinically needed. Pediatric : Pre-operative dose of 75 IU VWF:RCo/kg/body weight; subsequent doses of 50-75 IU VWF:RCo/kg body weight at 8-12 hour intervals post-operative as clinically needed. Dosage based on protocol used in the Alphanate prospective clinical trial according to judgment of the investigator. Pediatric Use