Europe — EMA
Icatibant Fresenius (Icatibant Acetate)
GNH USA supplies Icatibant Fresenius (Icatibant Acetate), a bradykinin B2 receptor antagonist for acute hereditary angioedema attacks.
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What is Icatibant Acetate?
Icatibant acetate, the active ingredient in Icatibant Fresenius, is a bradykinin B2 receptor antagonist presented as a sterile solution for injection for subcutaneous administration. It is indicated for the treatment of acute attacks of hereditary angioedema (HAE) types I and II in patients with a confirmed diagnosis, providing rapid symptom relief.
GNH USA supplies Icatibant Fresenius as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑controlled distribution across EU and other regulated markets and research institutions.
What is Icatibant Acetate used for?
Icatibant Fresenius is used to treat bradykinin‑mediated hereditary angioedema attacks.
- Acute hereditary angioedema type I: rapid reduction of swelling during an attack. - Acute hereditary angioedema type II: rapid reduction of swelling during an attack. - Hereditary angioedema attacks (any type): alleviation of symptoms and restoration of normal function.
What are the side effects of Icatibant Acetate?
Icatibant Fresenius may cause a range of adverse reactions.
Common Side Effects: - Injection site pain or erythema. - Local swelling or induration at the injection site. - Headache. - Nausea. - Dizziness. - Fatigue.
Serious or Rare Side Effects: - Hypersensitivity reactions, including rash or urticaria. - Anaphylaxis or severe systemic allergic response. - Severe hypotension. - Angioedema unrelated to HAE. - Infection at the injection site.
What precautions apply to Icatibant Acetate?
Before using Icatibant Fresenius, consider the following safety measures.
- Confirm diagnosis: ensure the patient has a documented hereditary angioedema type I or II. - Monitor for hypersensitivity: observe the patient after injection for any allergic signs. - Avoid in patients with known hypersensitivity to icatibant acetate or any excipients. - Use with caution in patients receiving ACE inhibitors, as bradykinin levels may be elevated. - Pregnancy and lactation: limited data are available; weigh potential benefits against unknown risks. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Icatibant Acetate interact with?
Icatibant Fresenius can interact with other medicines that affect the bradykinin pathway or vascular tone.
Major Interactions (Avoid): - ACE inhibitors: may increase bradykinin levels and raise the risk of angioedema. - C1‑esterase inhibitor concentrates: concurrent use is not recommended due to overlapping mechanisms.
Moderate Interactions (Monitor Closely): - Angiotensin receptor blockers: may modestly increase bradykinin activity. - Estrogen‑containing oral contraceptives: can influence HAE severity and may require closer monitoring. - Other bradykinin‑targeting agents: combined use could alter efficacy or safety profile.



