Drug updated on 4/10/2024
| Dosage Form | Injection (subcutaneous; 10 mg/mL) |
| Drug Class | Bradykinin B2 receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
Summary
- 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 Title | Year | Source |
|---|---|---|
| Firazyr (icatibant) Prescribing Information. | 2024 | Takeda Pharmaceuticals America, Inc. Lexington, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Clinical manifestations of hereditary angioedema and a systematic review of treatment options. | 2021 | Laryngoscope Investigative Otolaryngology |
| Clinical features of genetically characterized types of hereditary angioedema with normal C1 inhibitor: A systematic review of qualitative evidence. | 2020 | Orphanet Journal or rare diseases |
| Effect of icatibant on angiotensin-converting enzyme inhibitor-induced angioedema: A meta-analysis of randomized controlled trials. | 2019 | Journal of Clinical Pharmacy and Therapeutics |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| The international WAO/EAACI guideline for the management of hereditary angioedema – The 2021 revision and update. | 2022 | World Allergy Organization Journal |
| Guidelines for management of hereditary angioedema: What is new? What is missing? | 2022 | Allergy and Asthma Proceedings |
| US HAEA medical advisory board 2020 guidelines for the management of hereditary angioedema. | 2021 | Journal of Allergy and Clinical Immunology – In practice |
| US HAEA medical advisory board 2020 guidelines for the management of hereditary angioedema. | 2020 | American Academy of Allergy, Asthma & Immunology |
| The international/Canadian hereditary angioedema guideline. | 2019 | Allergy, Asthma & Clinical Immunology |