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.

None known.

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.

Pediatric Use: Clinical trials for safety and effectiveness in pediatric hemophilia A patients have not been conducted. The hemostatic efficacy of Alphanate has been studied in 20 pediatric subjects with VWD 18 years of age and under. Based on the data from a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo

Geriatric Use: No human or animal data. Use only if clearly needed

Haemostatics