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Molecule

Icatibant

Also known as icatibant acetate
Available on requestOrphanHaematology
Presentations
3
Brands
2
Manufacturers
2
Available from stock
0

Icatibant is a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. It is available as injection for subcutaneous use. MedsAcross supplies Icatibant for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Bradykinin B2 Receptor Antagonist, Bradykinin B2 Receptor Antagonists
ATC classification
B06AC02 Icatibant · Other blood-related medicines, subgroup B06A, subgroup B06AC
US FDA first approval
25 August 2011
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Injection
Identifiers
UNII 7PG89G35Q7RxCUI 1148138CAS 130308-48-4DrugBank DB06196Q902379

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

FIRAZYR ® (icatibant) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. FIRAZYR is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Source: US FDA prescribing information

How it works

Icatibant is a competitive antagonist selective for the bradykinin B2 receptor, with an affinity similar to bradykinin. Hereditary angioedema is caused by an absence or dysfunction of C1-esterase-inhibitor, a key regulator of the Factor XII/kallikrein proteolytic cascade that leads to bradykinin production. Bradykinin is a vasodilator which is thought to be responsible for the characteristic HAE symptoms of localized swelling, inflammation, and pain. Icatibant inhibits bradykinin from binding the B2 receptor and thereby treats the clinical symptoms of an acute, episodic attack of HAE.

Source: US FDA prescribing information

Dosing overview

30 mg injected subcutaneously in the abdominal area. If response is inadequate or symptoms recur, additional injections of 30 mg may be administered at intervals of at least 6 hours. Do not administer more than 3 injections in 24 hours. Patients may self-administer upon recognition of an HAE attack.

Source: US FDA prescribing information

Warnings and precautions

Laryngeal attacks: Following treatment of laryngeal attacks with FIRAZYR, advise patients to seek immediate medical attention. Laryngeal Attacks Given the potential for airway obstruction during acute laryngeal HAE attacks, patients should be advised to seek medical attention in an appropriate healthcare facility immediately in addition to treatment with FIRAZYR.

Source: US FDA prescribing information

Side effects

The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash.

Source: US FDA prescribing information

Interactions

ACE Inhibitors FIRAZYR is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where FIRAZYR may attenuate the antihypertensive effect of ACE inhibitors. Clinical trials to date have excluded subjects taking ACE inhibitors.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

3 presentations of Icatibant, sorted by availability.

MedicineManufacturerRegisterAvailability
Icatibant 30 mg/3 mL injectionSubcutaneousGeneric name—US FDAAvailable on request
Firazyr 30 mg/3 mL injectionSubcutaneousTakeda PharmaceuticalsUS FDAAvailable on request
Sajazir 30 mg/3 mL injectionSubcutaneousCycle Pharmaceuticals Ltd-UkUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 25 August 2011Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Icatibant available for export from India?

Yes, on request. MedsAcross lists 3 presentations of Icatibant and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Icatibant have?

The catalogue lists 2 brand names for Icatibant, including Firazyr, Sajazir.

Is Icatibant approved by the US FDA?

Yes. The US FDA first approved Icatibant on 25 August 2011, according to Drugs@FDA.

Is Icatibant authorised in the European Union?

Yes. Icatibant has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Icatibant need cold chain shipping?

No listed presentation of Icatibant is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Icatibant in?

Icatibant is classified under ATC code B06AC02 (Icatibant).

References

  1. Firazyr prescribing information (Takeda Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 7 July 2025
  2. Firazyr: European public assessment report (EPAR). European Medicines Agency. Retrieved 6 August 2026
  3. Icatibant Accord: European public assessment report (EPAR). European Medicines Agency. Retrieved 16 April 2026

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