Coagulation Factor IX, recombinant human (Ixinity)

OFFICE-ADMINISTRATION

FDA Approved Indications:
  • Indicated in adults and children at least 12 years of age with hemophilia B for:
    • Control and prevention of bleeding episodes
    • Perioperative management
Prior authorization criteria:
  • Patient has hemophilia B, AND
  • Is at least 12 years of age or older, AND
  • Patient does not have a known hypersensitivity to hamster protein
Dosing:
  • One international unit (IU) of Ixinity per kg body weight increased the circulating activity of factor IX by 0.98 IU/dL
  • Initial: Required factor IX units (IU) = body wieght (kg) x desired factor IX increase (% of normal of IU/dL) x reciprocal of observed recovery (IU/kg per IU/dL)
  • Maintenance dose: Depends upon the type of bleed or surgery, clinical response, and the severity of the underlying factor IX deficiency
Approval:
  • 1 year

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