Product image of Icatibant Fresenius (Icatibant Acetate) supplied by GNH India

Icatibant Fresenius

Active Ingredient:
Icatibant Acetate
Origin:
EU

Icatibant Fresenius (Icatibant Acetate)

Icatibant acetate, the active ingredient in Icatibant Fresenius, is a bradykinin B2 receptor antagonist presented as an injection solution for subcutaneous use. It treats acute attacks of hereditary angioedema in patients with C1‑inhibitor deficiency and is marketed in the European Union as a prescription‑only product.

GNH India supplies Icatibant Fresenius as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Fresenius Kabi Polska Sp. Z O.O.

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Indications & Clinical Uses

  • Icatibant Fresenius acts on the bradykinin pathway to relieve swelling in hereditary angioedema.
  • Acute attacks of hereditary angioedema (C1‑inhibitor deficiency): rapid reduction of swelling and pain.
  • Hereditary angioedema type I and II: provides symptomatic relief during attacks.
  • Bradykinin‑mediated angioedema: alleviates swelling caused by excess bradykinin.

How It Works

  • Icatibant acetate selectively blocks the bradykinin B2 receptor on vascular endothelial cells, preventing bradykinin‑induced vasodilation and increased vascular permeability. By inhibiting this receptor, the drug reduces the fluid extravasation that leads to the characteristic swelling of hereditary angioedema attacks.

Side Effects

Icatibant may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Injection site pain: discomfort at the subcutaneous injection site.
  • Erythema: localized redness around the injection area.
  • Nausea: mild gastrointestinal upset.
  • Headache: transient head discomfort.
  • Dizziness: brief episodes of light‑headedness.
  • Swelling at injection site: minor local edema.

Serious or Rare Side Effects

  • Hypersensitivity reactions: rash, itching, or hives.
  • Anaphylaxis: severe allergic response requiring immediate medical attention.
  • Severe hypotension: marked drop in blood pressure.
  • Angioedema unrelated to HAE: unexpected swelling in other regions.
  • Thrombocytopenia: low platelet count observed in rare cases.
  • Urticaria: widespread hives.

Precautions & Warnings

  • Before using Icatibant Fresenius, consider the following safety measures.
  • Pregnancy: safety not established; use only if potential benefit justifies the risk.
  • Breastfeeding: unknown excretion; weigh maternal benefit against infant risk.
  • Renal impairment: no dosage adjustment required, but monitor for accumulation.
  • Concomitant ACE inhibitors: may increase bradykinin levels; observe for worsening edema.
  • Hypersensitivity: discontinue immediately if allergic signs appear.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Icatibant may interact with other medicines that affect the bradykinin system or vascular tone.

Major Interactions (Avoid)

  • ACE inhibitors: additive bradykinin effect may precipitate angioedema.
  • Angiotensin receptor blockers: similar risk of enhanced bradykinin activity.
  • Other bradykinin B2 antagonists: no added benefit and may increase adverse events.

Moderate Interactions (Monitor Closely)

  • C1‑inhibitor concentrate: sequential use may be needed; monitor clinical response.
  • Antihistamines: may mask early signs of hypersensitivity; observe patient.
  • NSAIDs: can exacerbate swelling; watch for increased edema.

Frequently Asked Questions

Icatibant Fresenius is indicated for the treatment of acute attacks of hereditary angioedema caused by C1‑inhibitor deficiency. It works by rapidly reducing swelling and associated pain during an HAE episode.

Icatibant acetate is a selective antagonist of the bradykinin B2 receptor. By blocking this receptor, it prevents bradykinin‑induced vasodilation and vascular permeability, thereby limiting the fluid leakage that causes swelling in hereditary angioedema.

The dosing regimen for Icatibant Fresenius is determined by the prescribing clinician based on the patient’s condition, severity of the attack, and clinical guidelines. The prescriber will specify the exact dose and administration schedule.

Safety data for icatibant acetate in pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision should be made by a qualified healthcare professional.

To place an order, submit an enquiry on the product page at gnhindia.com, indicating the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and necessary import documentation.

Icatibant is a bradykinin B2 receptor antagonist, whereas other therapies such as C1‑inhibitor concentrates replace the deficient protein. Icatibant offers a subcutaneous route and rapid symptom relief, while C1‑inhibitor products are administered intravenously and work by restoring the missing inhibitor.

Icatibant Fresenius should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Keep the product in its original packaging until ready for use to maintain stability.

The medication is supplied as a sterile injection solution for subcutaneous injection. A healthcare professional administers the dose into the subcutaneous tissue, typically in the abdomen or thigh, following aseptic technique.

Serious risks include hypersensitivity reactions such as anaphylaxis, severe hypotension, and rare cases of thrombocytopenia. Patients should be monitored for signs of allergic reaction, sudden drop in blood pressure, or unexpected bleeding.

Icatibant is contraindicated in individuals with known hypersensitivity to icatibant acetate or any of the formulation excipients. Caution is also advised for patients with a history of severe allergic reactions to related medications.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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