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

Product code:
W68362001
Quantity:
1
Indicated for:
hereditary angioedema
Route of administration:
injectable
Substance:
icatibant (bradykinin receptor antagonist)
ATC
B06AC02 — Blood and blood forming organs | Other hematological agents | 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 latest medicines list:
01-04-2025
Product code:
W68362001
Concentration:
30mg
Pharmaceutical form:
solution for injection in pre-filled syringe
Quantity:
1
Product type:
Generic medicine
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

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