C1 Esterase Inhibitor [Human] (Haegarda)

SELF ADMINISTRATION

Indications for Prior Authorization:

  • Indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients

Patients must meet the following criteria for the indication(s) above:

  • Chart note documentation provided from a physician who specializes in the treatment of Hereditary Angioedema, AND
  • HAE is confirmed by both of the following:
    • Patient has low levels of functional C1-INH protein (<50% of normal) at baseline, as defined by the laboratory reference values, AND
    • Patient has lower than normal serum C4 levels at baseline, defined by the laboratory reference values, AND
  • Patient has tried and failed or contraindicated to Danazol (age >16 years of age)
  • Patient is at least 12 years of age or older

Dosing:

  • 60 IU/kg of body weight by subcutaneous injection twice weekly (every 3 or 4 days)
  • Each vial is for single-use only

Approval:

  • One year