Criteria for BEROTRALSTAT CAP,ORAL
Exclusion Criteria
- Angioedema or abdominal pain not associated with C1 inhibitor deficiency, including hereditary angioedema with normal C1 inhibitor (HAE nC1-INH)
- Concomitant use with another prophylaxis agent for HAE (e.g., donidalorsen, garadacimab, or lanadelumab)
- Concomitant use with P-gp inducers
- End-stage renal disease (CrCl < 15 mL/min or requiring hemodialysis)
Inclusion Criteria
- Restricted to VA / VA Community Care allergy/immunology provider, dermatology provider, or locally designated expert
- Diagnosis of Hereditary Angioedema Type 1 or 2 as established by laboratory testing
- Long-term prophylaxis for HAE attacks or short-term prophylaxis prior to procedures or intubation
Laboratory & Diagnostic Requirements
- Diagnostic laboratory results must include a C4 level below the limit of normal and one of the following: C1 inhibitor (C1-INH) antigenic level below the limit of normal or C1-INH functional level below the limit of normal
- HAE with normal C1 inhibitor (HAE-nC1-INH) is caused by variants in genes such as FXII, PLG, KNG1, ANGPT1, MYOF, HS3ST6, CPN1, or DAB21P, or unidentified genetic causes