Alphanate250 IU/vial

Alphanate 250 IU/vial, (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.

Haemostatics

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 250 IU/vial 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 250 IU/vial 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 250 IU/vial prospective clinical trial according to judgment of the investigator. Pediatric Use- Hemophilia A Indication: Clinical trials for safety and effectiveness in pediatric hemophilia A patients 16 years of age and younger have not been conducted. VWD Indication: The hemostatic efficacy of Alphanate 250 IU/vial 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. There were no clinically important differences between pediatric patients and adults. Geriatric Use: No human or animal data. Use only if clearly needed.

Alphanate 250 IU/vial is for intravenous use only after reconstitution. Use plastic disposable syringes. Do not refrigerate after reconstitution. Reconstituted Alphanate 250 IU/vial 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 250 IU/vial at a rate exceeding 10 mL/minute.

None known.

Alphanate 250 IU/vial 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 250 IU/vial in >5% of patients are respiratory distress, pruritus, rash, urticaria, faceedema, 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 neededNursing 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 250 IU/vial 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:RCoGeriatric Use: No human or animal data. Use only if clearly needed

Haemostatics

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 250 IU/vial 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.

Pregnancy: No human or animal data. Use only if clearly needed Labor and Delivery: No human or animal data. Use only if clearly neededNursing Mothers: No human or animal data. Use only if clearly needed

Pediatric Use: Clinical trials for safety and effectiveness in pediatric hemophilia A patients have not been conducted. The hemostatic efficacy of Alphanate 250 IU/vial 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:RCoGeriatric Use: No human or animal data. Use only if clearly needed