Leaflet ICATIBANT TERAPIA 30mg solution for injection in pre-filled syringe


Indicated for: hereditary angioedema

Route of administration: injectable

Substance: icatibant (bradykinin receptor antagonist)

ATC: B06AC02 (Blood and blood forming organs | Other hematological agents | Drugs used in hereditary angioedema)

Icatibant is a bradykinin B2 receptor antagonist used in the treatment of hereditary angioedema (HAE) caused by C1-esterase inhibitor deficiency. It works by blocking the effects of bradykinin, a peptide responsible for vasodilation and increased vascular permeability, which are key mechanisms in HAE-associated swelling.

It is administered via subcutaneous injection and can rapidly reduce symptoms of acute angioedema episodes, including laryngeal, facial, or abdominal swelling. Compared to other HAE treatments, icatibant has a fast onset of action and effectively shortens the time to symptom relief.

Common side effects include injection site reactions, nausea, headache, and fever. Its use is restricted to patients diagnosed with HAE, as it is not effective for allergic angioedema or angioedema induced by ACE inhibitors.

General data about ICATIBANT TERAPIA 30mg

  • Substance: icatibant
  • Date of last drug list: 01-04-2025
  • Commercial code: W68362001
  • Concentration: 30mg
  • Pharmaceutical form: solution for injection in pre-filled syringe
  • Quantity: 1
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: PHARMADOX HEAITHCARE LTD - MALTA
  • Holder: TERAPIA S.A. - ROMANIA
  • Number: 14190/2021/01
  • Shelf life: 2 years

Concentrations available for icatibant

  • 10mg/ml
  • 30mg