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 a subcutaneous injection solution for subcutaneous use. It is indicated for the treatment of acute attacks of hereditary angioedema in patients with this rare, potentially life‑threatening disorder.

GNH India supplies Icatibant Fresenius as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides cold‑chain logistics to ensure product integrity during global distribution.

Manufacturer / TM Owner

Fresenius Kabi Italia S.R.L.

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Indications & Clinical Uses

Icatibant Fresenius is used to target the bradykinin‑mediated pathway that underlies hereditary angioedema attacks.

  • Hereditary angioedema type I: provides rapid reduction of swelling and pain during acute attacks.
  • Hereditary angioedema type II: delivers prompt symptom relief by blocking bradykinin effects.
  • Hereditary angioedema with normal C1‑INH: offers effective control of swelling episodes in patients lacking functional C1 inhibitor.

How It Works

  • Icatibant acetate acts as a competitive antagonist at the bradykinin B2 receptor on vascular endothelial cells. By binding to this receptor, it prevents bradykinin from inducing vasodilation and increasing vascular permeability, which are key steps in the development of angioedema. The blockade rapidly reduces fluid extravasation and tissue swelling associated with hereditary angioedema attacks.

Side Effects

Icatibant Fresenius may be associated with 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 around the needle area.
  • Nausea: occasional gastrointestinal upset.
  • Headache: mild to moderate head discomfort.
  • Dizziness: transient light‑headedness.

Serious or Rare Side Effects

  • Hypersensitivity reactions: rash, urticaria, or angioedema.
  • Anaphylaxis: severe, potentially life‑threatening allergic response.
  • Severe hypotension: marked drop in blood pressure.
  • Thrombocytopenia: low platelet count observed in rare cases.
  • Acute pulmonary edema: rare fluid accumulation in lungs.

Precautions & Warnings

Before using Icatibant Fresenius, several safety considerations should be observed.

  • Assess severity of attack: confirm that the episode requires pharmacologic intervention.
  • Monitor for hypersensitivity: observe patient for signs of allergic reaction after injection.
  • Use under medical supervision: administration should be performed by trained healthcare personnel.
  • Contraindication in known hypersensitivity: avoid in patients with documented allergy to icatibant or its excipients.
  • Pregnancy and lactation: exercise caution as 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 medicines that influence the bradykinin pathway or affect its pharmacodynamics.

Major Interactions (Avoid)

  • ACE inhibitors: concurrent use can increase bradykinin levels and diminish therapeutic effect.
  • Angiotensin‑converting enzyme (ACE)–derived drugs: may potentiate bradykinin‑related adverse events.

Moderate Interactions (Monitor Closely)

  • Estrogen‑containing contraceptives: may alter bradykinin metabolism, requiring observation.
  • DPP‑4 inhibitors: potential additive effects on bradykinin activity.
  • Other B2 receptor antagonists: combined use may increase risk of hypotension.

Frequently Asked Questions

Icatibant Fresenius is indicated for the treatment of acute attacks of hereditary angioedema (HAE). It works by rapidly reducing swelling and pain associated with HAE episodes, providing prompt symptom relief for patients experiencing these potentially life‑threatening attacks.

Icatibant acetate is a competitive antagonist of the bradykinin B2 receptor. By binding to this receptor on vascular endothelial cells, it blocks bradykinin‑induced vasodilation and increased vascular permeability, which are central mechanisms that cause the swelling seen in hereditary angioedema.

The dose of Icatibant Fresenius is individualized by the prescribing clinician based on the patient’s condition, weight, and severity of the HAE attack. The prescriber determines the appropriate amount and frequency of subcutaneous injections according to current clinical guidelines.

Safety data for icatibant acetate in pregnancy and lactation are limited. The drug should be used only if the potential benefit justifies any possible risk to the fetus or infant. Healthcare providers should discuss the risk‑benefit profile with the patient before initiating therapy.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets. After verification of trade or institutional credentials, the sales team will respond with pricing, availability, shipping details (including cold‑chain handling if needed) and any required import documentation.

The primary alternative for acute HAE attacks is plasma‑derived or recombinant C1‑esterase inhibitor replacement therapy. Icatibant directly blocks the bradykinin B2 receptor, offering a rapid, subcutaneous option, whereas C1‑esterase inhibitors replace the deficient protein and are administered intravenously. Choice of therapy depends on patient preference, attack severity, and clinical response.

Icatibant Fresenius must be stored at 2‑8 °C (refrigerated). Keep the product in its original packaging, protect it from light, and avoid freezing or shaking the vial. If temporary temperature excursions occur, consult the product label before use.

Icatibant is given as a subcutaneous injection, typically into the abdomen or thigh. The injection should be performed by a trained healthcare professional using aseptic technique. Patients may be instructed on self‑administration after appropriate training, but initial dosing is usually supervised.

Serious risks include hypersensitivity reactions such as rash, urticaria, angioedema, and rare cases of anaphylaxis. Severe hypotension and, very rarely, acute pulmonary edema have been reported. Patients should be monitored after injection for any signs of allergic response or cardiovascular instability.

Icatibant is contraindicated in individuals with a known hypersensitivity to icatibant acetate or any of its excipients. Caution is advised for patients with uncontrolled cardiovascular disease, severe hypotension, or those who are pregnant or breastfeeding unless the potential benefit outweighs the risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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