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
Last review date: June 10, 2019