Drug updated on 12/11/2024
| Dosage Form | Injection (subcutaneous; 10 mg/mL) |
| Drug Class | Bradykinin B2 receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Effectiveness in hereditary angioedema (HAE) and HAE with normal C1 inhibitor (C1-INH) (HAEnCI): Icatibant is used for abortive treatment in HAE and on-demand treatment in HAEnCI; however, specific numerical outcomes on effectiveness are not provided. Additionally, no direct comparisons are available between icatibant and other treatment options (C1 esterase inhibitor (C1-INH), ecallantide, fresh frozen plasma, progestins, and tranexamic acid) in terms of effectiveness outcomes.
- Population Subgroup Impact: While subgroup-specific data on icatibant effectiveness is not detailed, HAEnCI with a mutation in the coagulation factor XII gene (F12) (HAE-FXII) and HAEnCI with a specific mutation in the plasminogen gene (HAE-PLG) populations exhibited estrogen sensitivity, with a significant disease impact observed in HAE-FXII females (male ratio 1:10) and a less pronounced effect in HAE-PLG (male ratio 1:3). Additionally, asphyxia was infrequently reported (2 cases in HAE-FXII, 3 cases in HAE-PLG), with tongue swelling as a notable clinical feature in HAE-PLG.
- Effectiveness Data Limitations: No subgroup-specific efficacy variations for icatibant are documented, and there is no information regarding the effectiveness of icatibant across different population types or subgroups within HAE and HAEnCI.
- There is no safety information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Firazyr (icatibant) Prescribing Information. | 2024 | Takeda Pharmaceuticals U.S.A., 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 |
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. | 2020 | American Academy of Allergy, Asthma & Immunology |
| The international/Canadian hereditary angioedema guideline. | 2019 | Allergy, Asthma & Clinical Immunology |