Coagulation Factor IX, recombinant human (Ixinity)

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