ICATIBANT STADA 30mg 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 STADA 30mg

Substance: icatibant

Date of last drug list: 01-06-2025

Commercial code: W68417001

Concentration: 30mg

Pharmaceutical form: injection solution in pre-filled syringe

Quantity: 1

Product type: generic

Price: 4000.72 RON

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

Marketing authorisation

Manufacturer: PHARMADOX HEAITHCARE LTD - MALTA

Holder: STADA M&D S.R.L. - ROMANIA

Number: 14178/2021/01

Shelf life: 2 years

Concentrations available for icatibant

10mg/ml, 30mg

Compensation lists for ICATIBANT STADA 30mg STADA

NHP 6.22 (C2) - Hereditary angioedema

Price

Copayment

Patient

4000.72 RON

4000.72 RON

0.00 RON