TAKHZYRO (lanadelumab)

TAKHZYRO (lanadelumab) 

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