Antihemophilic factor/von willebrand factor complex

ALPHANATE is indicated for: Treatment and prevention of bleeding episodes and perioperative management in adult and pediatric patients with Factor VIII (FVIII) deficiency due to hemophilia A. Perioperative management in adult and pediatric patients with Type 1 and Type 2 von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. Perioperative management in minor surgery in adult and pediatric patients with Type 3 VWD. ALPHANATE (antihemophilic factor/von Willebrand factor complex [human]), is indicated for: Treatment and prevention of bleeding episodes and perioperative management in adult and pediatric patients with Factor VIII (FVIII) deficiency due to hemophilia A.

ALPHANATE contains antihemophilic factor (FVIII) and von Willebrand factor (VWF), constituents of normal plasma. 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. After administration, ALPHANATE temporarily replaces the missing coagulation FVIII and VWF needed for effective hemostasis.

For intravenous injection after reconstitution only. ALPHANATE contains the labeled amount of factor VIII (FVIII) expressed in International Units (IU) FVIII/vial and von Willebrand Factor (VWF): Ristocetin Cofactor activity in IU VWF:RCo/vial. Treatment and Prevention of Bleeding Episodes and Excess Bleeding During and After Surgery in Patients with Hemophilia A. Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL). Dosing frequency determined by the type of bleeding episode and the recommendation of the treating physician. Treatment and Prevention of Excess Bleeding During and After Surgery or Other Invasive Procedures in Patients with von Willebrand Disease. Adults: Pre-operative dose of 60 IU VWF:RCo/kg body weight, subsequent doses of 40 IU to 60 IU VWF:RCo/kg body weight.

None. None.

Anaphylaxis or severe hypersensitivity reactions have occurred. Discontinue treatment with ALPHANATE and administer appropriate emergency treatment should symptoms of anaphylaxis or severe hypersensitivity occur. Neutralizing antibodies to Factor VIII and VWF have occurred. Thromboembolic events (TE) have occurred in patients with VWD, especially with known risk factors. Monitor patients for signs and symptoms of TE. Intravascular hemolysis may occur with infusion of large doses of FVIII/von Willebrand Factor Complex. Should this condition occur and lead to progressive hemolytic anemia, discontinue administration of ALPHANATE and consider alternative therapy. Rapid administration may result in vasomotor reactions.

The most common adverse reactions reported with ALPHANATE (incidence >1% of infusions) were pruritus, headache, back pain, paresthesia, respiratory distress, facial edema, pain, rash and chills.

ALPHANATE is stable for three years, up to the expiration date printed on its label, provided that the storage temperature does not exceed 25 °C (77 °F). Do not freeze.