Icatibant
Drugs Used In Hereditary Angioedema
Sold as FIRAZYR · SAJAZIR
- Drug class
- Drugs Used In Hereditary Angioedema
- Availability
- Prescription only
- Routes
- Subcutaneous
- Markets covered
- 4
- Products on record
- 31
- FDA reports (12 mo)
- 810
Overview
Plain-language summary, compiled from the cited regulatory records
Icatibant is a bradykinin B2 receptor antagonist [1]. It belongs to the drug class of drugs used in hereditary angioedema [1].
Icatibant is approved for the treatment of acute attacks of hereditary angioedema (HAE) in adults aged 18 and older [1]. It is available under the brand name SAJAZIR [1].
In the past 12 months, there have been 810 adverse event reports associated with icatibant [2]. The most frequently reported conditions in these reports include hereditary angioedema, drug ineffective, weight decreased, weight increased, and product dose omission issue [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 24 | May 29, 2026 |
| CA Canada | Health Canada | 4 | December 12, 2025 |
| EU European Union | EMA | 2 | April 16, 2026 |
| US United States | FDA | 1 | February 16, 2024 |
GBUnited Kingdom· MHRA
24 products
Uses
Icatibant is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.
How to take
CACanada· Health Canada
4 products
Uses
FIRAZYR (icatibant injection) is indicated for: • the treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older with C1-esterase inhibitor deficiency. FIRAZYR is supplied through a controlled distribution program that is accessed by patients and pharmacies.
4 Administration). 1 Pediatrics ≥ 2 years to <18 years of age and weighing ≥12 kg: Based on the data submitted and reviewed by Health Canada, the safety and efficacy of FIRAZYR in pediatric patients aged 2 years and older who weigh ≥12 kg have been established.
Therefore, Health Canada has authorized an indication for pediatric use. < 2 years of age and in patients weighing < 12 kg: Studies in children aged less than 2 years or children weighing less than 12 kg have not been performed. 3 Pediatrics).
3 Pharmacokinetics).
EUEuropean Union· EMA
2 products
Uses
Icatibant Accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.
How to take
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE SAJAZIR (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. SAJAZIR (icatibant) injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
( 1 )
How to take
Drug interactions
Known interactions involving Icatibant. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL068310349 · revised March 13, 2026
- [2]Health Canada (DPD) · 02425696 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/005083 · revised April 16, 2026
- [4]FDA DailyMed · 1756aca0-21a1-48… · revised February 16, 2024 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.