Generic: Alphanate  |  Dosage Form: IV Infusion  |  Manufacturer: Grifols Biologicals LLC

Indications

• 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.

Dosage & Administration

• 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

• 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.

• 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.

Interaction

Contraindications

Side Effects

Precautions & Warnings

Therapeutic Class