Alphanate 250 IU/vial IV Infusion

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–

• 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 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.