Antihemophilic Factor VIII, recombinant (Kovaltry)

Antihemophilic Factor VIII, recombinant (Kovaltry)

OFFICE ADMINISTRATION

FDA Approved Indications:

• Indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes

Patients must meet the following criteria for the indications above:

• On-demand treatment, perioperative management or routine prophylaxis for patients with hemophilia A
• Patient does not have a known hypersensitivity to mouse or hamster proteins

Dosing:

• Control of bleeding episodes and perioperative management:
  • Required dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal or IU/dL) x reciprocal of expected/observed recovery (e.g., 0.5 for a recovery of 2 IU/dL per IU/kg)
  • Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg) x 2 (IU/dL per IU/kg)
• Routine prophylaxis:
  • Adults and adolescents: 20-40 IU/kg 2 or 3 times per week
  • Children less than or equal to 12 years old: 25-50 IU/kg 2 times per week, 3 times per week, or every other day

Approval:

• 1 year