Lanadelumab (Takhzyro™)

SELF ADMINISTRATION

Indications for Prior Authorization:
  • Indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 12 years of age or older
Patients must meet the following criteria for the indication(s) above:
  • Age greater than or equal to 12 years, AND
  • Used for prophylaxis against angioedema attacks due to Hereditary Angioedema (HAE), AND
  • Chart note documentation is provided from a consulting allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders, AND
  • The patient has HAE type I or type II confirmed by both of the following (documentation required):
    • Patient has low levels of functional C1-INH (<50% of normal) at baseline, as defined by the laboratory reference values, AND
    • Patient has lower than normal serum C4 levels at baseline, as defined by the laboratory reference values, AND
  • Patient has at least one HAE attack per month, AND
  • Medications known to cause angioedema (i.e., Angiotensin Converting Enzyme [ACE] inhibitors, estrogens, Angiotensin Receptor Blockers [ARBs] have been evaluated and discontinued when appropriate, AND
  • For patients age >16 years of age and not pregnant: Patient has tried and failed or contraindicated to Danazol, AND
  • Patient has tried and failed Haegarda, AND
  • Cinryze, Haegarda, and/or Takhzyro will not be used together.
Dosing:
  • Initial:  300 mg by subcutaneous injection every 2 weeks; dosing every 4 weeks may be considered in patients well-controlled (e.g., attack free) for > 6 months.
  • Each vial is for single-use only (preservative free)
Approval:
  • One year

Last review date: June 10, 2019