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

Icatibant Fresenius

Active Ingredient:
Icatibant Acetate
Origin:
EU

Icatibant Fresenius (Icatibant Acetate)

Icatibant, the active ingredient in Icatibant Fresenius, is a Bradykinin B2 receptor antagonist presented as an injection solution for subcutaneous administration. It treats acute attacks of hereditary angioedema in patients with C1‑inhibitor deficiency.

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

Manufacturer / TM Owner

Fresenius Kabi S.R.O.

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Indications & Clinical Uses

  • Icatibant acts on the bradykinin pathway to relieve swelling in hereditary angioedema.
  • Acute hereditary angioedema attacks: rapid reduction of swelling and relief of symptoms.

How It Works

  • Icatibant is a competitive antagonist of the bradykinin B2 receptor. By binding to this receptor, it blocks bradykinin‑mediated vasodilation and increased vascular permeability, thereby preventing the fluid extravasation that causes the swelling characteristic of hereditary angioedema attacks.

Side Effects

Icatibant may cause a range of adverse reactions following subcutaneous injection.

Common Side Effects

  • Injection site pain or erythema
  • Headache
  • Nausea or vomiting
  • Dizziness
  • Fatigue
  • Mild fever

Serious or Rare Side Effects

  • Anaphylactic or severe hypersensitivity reactions
  • Angioedema involving the airway
  • Severe hypotension
  • Thrombocytopenia
  • Cardiovascular collapse
  • Acute renal impairment

Precautions & Warnings

  • Before initiating therapy, clinicians should evaluate patient history and monitor for adverse events.
  • Assess severity of attack: confirm hereditary angioedema diagnosis before use.
  • Monitor for hypersensitivity: observe for signs of allergic reaction after each injection.
  • Avoid in known hypersensitivity: do not administer to patients with documented allergy to icatibant or its excipients.
  • Use with caution in pregnancy or lactation: safety data are limited; weigh benefits against potential risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Icatibant may interact with other medications that affect the bradykinin pathway or vascular tone.

Major Interactions (Avoid)

  • Concomitant use of other bradykinin B2 receptor antagonists: risk of additive pharmacologic effect.
  • Potent vasodilators (e.g., nitroglycerin, hydralazine): may exacerbate hypotension.

Moderate Interactions (Monitor Closely)

  • ACE inhibitors: possible reduction in therapeutic benefit.
  • Diuretics: may influence fluid balance and blood pressure.
  • Co‑administration with other subcutaneous biologics: could increase local injection‑site reactions.

Frequently Asked Questions

Icatibant Fresenius is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients with C1‑inhibitor deficiency. It works by rapidly reducing swelling and associated symptoms during an HAE episode.

Icatibant is a competitive antagonist of the bradykinin B2 receptor. By blocking this receptor, it prevents bradykinin‑induced vasodilation and increased vascular permeability, which are key drivers of the swelling seen in hereditary angioedema.

The prescribed dose of icatibant is determined by the treating physician based on the patient’s clinical condition. Typically, a single subcutaneous injection is administered at the onset of an HAE attack, with additional doses given only if medically required.

Safety data for icatibant during pregnancy and lactation are limited. It is classified as pregnancy category unknown, so it should only be used when the potential benefit justifies the potential risk to the fetus or infant.

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 where required) and import documentation.

The primary alternative for HAE attacks is plasma‑derived or recombinant C1‑inhibitor concentrate. While C1‑inhibitor replaces the deficient protein, icatibant directly blocks the bradykinin B2 receptor. Icatibant offers a rapid, subcutaneous option without the need for intravenous infusion, but C1‑inhibitor may be preferred in patients with contraindications to bradykinin blockade.

Icatibant should be stored refrigerated at 2‑8 °C. Keep the vial in its original packaging, protect it from light, and do not freeze or shake the solution. If temporary storage at room temperature is unavoidable, limit exposure to no more than 30 °C for a short period.

Icatibant is administered as a single subcutaneous injection, usually into the abdomen or thigh. The injection site should be cleaned with an alcohol swab, and the needle inserted at a 45‑ to 90‑degree angle. Patients or caregivers can be trained to perform the injection at the onset of an HAE attack.

Serious risks include severe hypersensitivity reactions such as anaphylaxis, airway‑compromising angioedema, and profound hypotension. Patients should be instructed to seek immediate medical attention if they experience difficulty breathing, swelling of the throat, or a sudden drop in blood pressure after injection.

Icatibant is contraindicated in individuals with known hypersensitivity to icatibant acetate or any of its excipients. Caution is also advised for patients with a history of severe allergic reactions, uncontrolled cardiovascular disease, or those who are pregnant or breastfeeding without a clear benefit.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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