Icatibant acetate



Drug updated on 6/11/2024

Dosage FormInjection (subcutaneous; 10 mg/mL)
Drug ClassBradykinin B2 receptor antagonists
Ongoing and
Completed Studies


  • For treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

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  • Icatibant acetate (Firazyr) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years and older. It has shown effectiveness in managing symptoms during these acute episodes, comparing favorably with other treatments such as C1-INH replacement, ecallantide, and fresh frozen plasma.
  • Three systematic reviews/meta-analyses were examined to gather information about Firazyr's use for HAE and ACEI-induced angioedema.
  • In cases of HAE with normal C1 inhibitor, including mutations leading to HAE-FXII, HAE-PLG among others, icatibant acetate is part of the on-demand treatment regimen showing efficacy across different mutation types.
  • The safety profile for icatibant acetate appears robust; adverse effects reported are relatively minor, primarily involving reactions at the injection site but not significantly affecting overall tolerance or safety.
  • For ACEI-induced angioedema, there's a contested effectiveness. While some reduction in time to symptom resolution was observed compared to placebo or conventional treatments, it wasn't statistically significant, indicating potential but unconfirmed benefit from using icatibant acetate here.
  • Across various patient subgroups and genetic types within the context of HAE, its role remains constant while being generally well-tolerated, making it suitable even for those at risk from ACEI-induced angioedema, although conclusive evidence supporting superiority over placebo or conventional treatments isn't firmly established yet.

Product Monograph / Prescribing Information

Document TitleYearSource
Firazyr (icatibant) Prescribing Information.2024Takeda Pharmaceuticals America, Inc. Lexington, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines