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 injectable solution for subcutaneous use. It is indicated for the treatment of hereditary angioedema (C1‑inhibitor deficiency) in patients who experience acute swelling attacks.

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

Manufacturer / TM Owner

Fresenius Kabi Pharma Portugal, Lda.

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Indications & Clinical Uses

Icatibant Fresenius is a bradykinin B2 receptor antagonist used to manage hereditary angioedema attacks. It acts on the pathway that mediates swelling caused by excess bradykinin.

  • Hereditary angioedema (type I C1‑INH deficiency): provides rapid relief of acute swelling episodes.
  • Hereditary angioedema (type II C1‑INH deficiency): reduces severity and duration of attacks.
  • Hereditary angioedema with normal C1‑INH: offers symptom control during acute episodes.

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 curtails the cascade that leads to fluid extravasation and tissue swelling characteristic of hereditary angioedema attacks.

Side Effects

Icatibant Fresenius may cause a range of adverse reactions following subcutaneous administration.

Common Side Effects

  • Injection site pain: mild to moderate discomfort at the injection site.
  • Redness or erythema: localized skin reddening.
  • Swelling at injection site: transient edema.
  • Nausea: occasional gastrointestinal upset.
  • Headache: mild to moderate intensity.
  • Dizziness: transient light‑headedness.

Serious or Rare Side Effects

  • Hypersensitivity reactions: rash, pruritus, or urticaria.
  • Anaphylaxis: severe, potentially life‑threatening allergic response.
  • Severe hypotension: marked drop in blood pressure.
  • Angioedema unrelated to HAE: unexpected swelling in other areas.
  • Severe injection‑site necrosis: tissue damage at the site.
  • Thrombotic events: rare clot formation.

Precautions & Warnings

Before initiating therapy with Icatibant Fresenius, clinicians should consider several safety aspects.

  • Confirm diagnosis: ensure the patient has hereditary angioedema confirmed by laboratory testing.
  • Hypersensitivity: avoid use in individuals with known allergy to icatibant or any excipients.
  • Cardiovascular disease: monitor patients with unstable heart conditions due to potential blood‑pressure effects.
  • Pregnancy and lactation: safety has not been established; use only if the potential benefit outweighs risk.
  • Concomitant ACE‑inhibitors: be aware of additive bradykinin effects that may increase angioedema risk.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Icatibant Fresenius can interact with other medicines that influence the bradykinin pathway or vascular tone.

Major Interactions (Avoid)

  • ACE inhibitors: may potentiate bradykinin‑mediated angioedema.
  • Other bradykinin B2 antagonists: concurrent use can lead to unpredictable pharmacodynamics.

Moderate Interactions (Monitor Closely)

  • Estrogen‑containing contraceptives: can increase frequency of HAE attacks.
  • C1‑inhibitor concentrate: may reduce the need for icatibant in some patients.
  • DPP‑4 inhibitors: theoretical risk of altered bradykinin metabolism.
  • Diuretics: monitor blood pressure due to possible additive hypotensive effect.

Frequently Asked Questions

Icatibant Fresenius is used to treat acute attacks of hereditary angioedema (HAE) caused by C1‑inhibitor deficiency. By blocking the bradykinin B2 receptor, it rapidly reduces swelling and discomfort associated with HAE episodes.

Icatibant acetate is a selective antagonist of the bradykinin B2 receptor. It prevents bradykinin from binding to this receptor on blood vessels, thereby inhibiting the vasodilation and increased vascular permeability that cause the swelling seen in HAE.

The dose of Icatibant Fresenius is determined by the prescribing clinician based on the patient’s condition, weight, and severity of the attack. The medication is administered subcutaneously, and the exact regimen should follow the prescriber’s instructions.

Safety of icatibant in pregnancy and lactation has not been established. It should only be used if the potential benefit justifies any possible risk to the fetus or infant, and this decision must be made by a qualified healthcare professional.

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

Icatibant is a bradykinin B2 receptor antagonist, whereas other approved HAE treatments include C1‑inhibitor concentrates (plasma‑derived or recombinant) and kallikrein inhibitors. Icatibant is administered subcutaneously and acts directly on the bradykinin pathway, offering rapid symptom relief without the need for intravenous infusion.

Icatibant Fresenius must be stored refrigerated at 2‑8 °C. Keep the product in its original packaging, protect it from light, and do not freeze or shake the vial. If temperature excursions occur, consult the supplier before use.

The medication is given as a subcutaneous injection, typically into the abdomen or thigh. The injection site should be rotated between doses, and aseptic technique must be followed. Patients or caregivers should be trained by a healthcare professional on proper administration.

Serious risks include hypersensitivity reactions such as anaphylaxis, severe hypotension, and rare cases of angioedema unrelated to HAE. Prompt medical attention is required if any signs of severe allergic reaction, sudden drop in blood pressure, or unexpected swelling occur.

Icatibant should not be used in individuals with known hypersensitivity to icatibant acetate or any of its excipients. Caution is also advised for patients with unstable cardiovascular disease, and it is generally avoided in pregnant or breastfeeding women unless clearly indicated by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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