ICATIBANT ZENTIVA 30mg 10mg / ml injection solution in pre-filled syringe medication leaflet

B06AC02 icatibant • 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 ZENTIVA 30mg 10mg / ml

Substance: icatibant

Date of last drug list: 01-06-2025

Commercial code: W68280001

Concentration: 10mg / ml

Pharmaceutical form: injection solution in pre-filled syringe

Quantity: 1

Product type: generic

Price: 3889.98 RON

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: PHARMADOX HEALTHCARE LTD. - MALTA

Holder: ZENIVA K.S. - REPUBLICA CEHA

Number: 14175/2021/01

Shelf life: 2 years

Concentrations available for icatibant

10mg/ml, 30mg

Compensation lists for ICATIBANT ZENTIVA 30mg 10mg / ml ZENTIVA

NHP 6.22 (C2) - Hereditary angioedema

Price

Copayment

Patient

3889.98 RON

3889.98 RON

0.00 RON