Europe — EMA
Ikatibant Fresenius (Icatibant Acetate)
GNH USA supplies Ikatibant 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 Ikatibant Fresenius, is a bradykinin B2 receptor antagonist presented as a subcutaneous injection for subcutaneous use. It treats acute attacks of hereditary angioedema in patients with a confirmed diagnosis.
GNH USA supplies Ikatibant Fresenius as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Icatibant Acetate used for?
Icatibant Acetate is used to manage bradykinin‑mediated swelling disorders, particularly hereditary angioedema. - Hereditary angioedema (HAE) type I and II: Reduces swelling and shortens the duration of acute attacks. - Acute bradykinin‑mediated angioedema: Provides rapid symptom relief during sudden episodes. - HAE with C1‑esterase inhibitor deficiency: Restores normal vascular permeability during crises.
What are the side effects of Icatibant Acetate?
Icatibant Acetate may cause a range of adverse reactions, most of which are related to the injection site or systemic exposure.
Common Side Effects: - Injection site pain: Discomfort at the site of subcutaneous administration. - Redness or erythema: Localized skin irritation. - Swelling at injection site: Mild to moderate edema. - Nausea: Transient gastrointestinal upset. - Headache: Mild to moderate intensity. - Dizziness: Transient sensation of light‑headedness.
Serious or Rare Side Effects: - Hypersensitivity reactions: Rash, itching, or hives. - Anaphylaxis: Severe, potentially life‑threatening allergic response. - Severe hypotension: Marked drop in blood pressure. - Angioedema unrelated to HAE: Unexpected swelling in other areas. - Thrombocytopenia: Low platelet count. - Injection‑site infection: Signs of local infection such as warmth or pus.
What precautions apply to Icatibant Acetate?
Before using Icatibant Acetate, consider the following safety measures. - Renal impairment: Monitor renal function and adjust therapy as needed. - Hepatic impairment: Use with caution and observe liver function tests. - Pregnancy: Safety not established; weigh potential benefits against risks. - Concomitant ACE inhibitors or ARBs: May increase bradykinin levels; monitor for angioedema. - Known hypersensitivity: Discontinue immediately if allergic reaction occurs. - Store at 2-8°C: Keep refrigerated, protect from light, do not freeze or shake.
What does Icatibant Acetate interact with?
Icatibant Acetate can interact with other medications that influence the bradykinin pathway or cardiovascular system.
Major Interactions (Avoid): - ACE inhibitors: Heightened risk of angioedema. - Angiotensin receptor blockers (ARBs): May amplify bradykinin‑mediated effects. - Other bradykinin‑targeting agents: Additive blockade could cause unexpected reactions.
Moderate Interactions (Monitor Closely): - Diuretics: Observe blood pressure and electrolyte balance. - Antihistamines: May mask early signs of hypersensitivity. - NSAIDs: Monitor for increased swelling or pain at injection site.



