Product image of Icatibant Ethypharm (Icatibant) supplied by GNH India

Icatibant Ethypharm

Active Ingredient:
Icatibant
Origin:
EU

Icatibant Ethypharm (Icatibant)

Icatibant, the active ingredient in Icatibant Ethypharm, is a bradykinin B2 receptor antagonist presented as a 30 mg/1 mL solution for injection for subcutaneous use. It treats acute attacks of hereditary angioedema in patients with C1‑inhibitor deficiency. The formulation is approved for use in the European Union and is administered by healthcare professionals trained in subcutaneous injection techniques.

GNH India supplies Icatibant Ethypharm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring consistent quality, regulatory compliance, and reliable cold‑chain logistics for injectable biologics.

Manufacturer / TM Owner

Ethypharm

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Indications & Clinical Uses

  • Icatibant acts on the bradykinin pathway, providing targeted therapy for hereditary angioedema and related swelling disorders.
  • Acute attacks of hereditary angioedema (HAE) in patients with C1‑inhibitor deficiency (type I or II): Icatibant rapidly reverses bradykinin‑induced vascular leakage, leading to a prompt decrease in swelling of the skin, gastrointestinal tract, and upper airway, thereby alleviating pain and reducing the risk of life‑threatening airway obstruction.
  • Hereditary angioedema type I and II episodes: the drug offers rapid symptom control by blocking bradykinin‑mediated edema, helping to restore normal function of affected tissues.

How It Works

  • Icatibant is a synthetic peptide that competitively binds to the bradykinin B2 receptor on endothelial cells. By occupying this receptor, it prevents endogenous bradykinin from activating the signaling cascade that increases vascular permeability and causes edema. The blockade is selective and reversible, allowing normal physiological bradykinin activity to resume after the drug is cleared. This targeted antagonism reduces the formation of localized swelling without affecting systemic blood pressure.

Side Effects

Icatibant may cause a range of adverse reactions, most of which are related to the injection site or systemic response.

Common Side Effects

  • Injection site pain
  • Redness or erythema at the injection site
  • Nausea

Serious or Rare Side Effects

  • Anaphylaxis (severe allergic reaction)
  • Angioedema unrelated to hereditary angioedema
  • Significant hypotension

Precautions & Warnings

Use of Icatibant requires careful assessment of patient-specific factors and monitoring for adverse events.

  • Pregnancy: safety not established; prescribe only if benefit outweighs potential risk.
  • Breastfeeding: unknown safety profile; consider risk versus benefit.
  • Renal impairment: no dose adjustment required, but monitor for accumulation.
  • Concomitant ACE inhibitors: may increase bradykinin levels; observe for signs of angioedema.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Icatibant can interact with other agents that influence bradykinin metabolism or immune response.

Major Interactions (Avoid)

  • ACE inhibitors (e.g., enalapril, lisinopril)
  • Angiotensin II receptor blockers (e.g., losartan, valsartan)
  • Neprilysin inhibitors (e.g., sacubitril)

Moderate Interactions (Monitor Closely)

  • Estrogen‑containing therapies (may increase HAE attack frequency)
  • Other subcutaneous injections administered at the same site (potential for altered absorption)

Frequently Asked Questions

Icatibant Ethypharm is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients who have a deficiency of C1‑inhibitor (type I or II). The medication works to quickly reduce swelling and associated symptoms during an HAE episode.

Icatibant is a competitive antagonist of the bradykinin B2 receptor. By binding to this receptor, it blocks the action of bradykinin, a peptide that increases vascular permeability and causes the swelling characteristic of HAE. This blockade limits edema formation during an attack.

The prescribed dose of Icatibant Ethypharm is determined by the treating physician. Typically, a single subcutaneous injection of the 30 mg/1 mL solution is administered at the onset of an HAE attack, with additional doses given only if clinically required.

Safety data for Icatibant in pregnancy and lactation are limited. It should be used only if the potential benefit justifies any possible risk to the fetus or infant. Healthcare providers will evaluate the individual situation before prescribing.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity of Icatibant Ethypharm. 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 handling) and the necessary import documentation.

The primary alternative to Icatibant is plasma‑derived or recombinant C1‑inhibitor concentrate, which replaces the deficient protein. Icatibant directly blocks bradykinin receptors, offering a rapid, protein‑free option that can be self‑administered subcutaneously, whereas C1‑inhibitor products are administered intravenously and require protein handling.

Icatibant Ethypharm should be stored refrigerated at 2‑8 °C. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking the solution. If the product must be transported, maintain the cold chain throughout the journey.

The medication is supplied as a sterile solution for injection. A healthcare professional (or a trained patient) administers a single subcutaneous injection into the abdomen or thigh using the pre‑filled syringe. The injection site should be rotated for subsequent doses if required.

The most serious adverse events include severe allergic reactions such as anaphylaxis, unexpected angioedema unrelated to HAE, and significant hypotension. Patients should be monitored after injection, and any signs of systemic allergic response require immediate medical attention.

Icatibant is contraindicated in individuals with known hypersensitivity to the active ingredient or any excipients in the formulation. Patients with a history of severe allergic reactions to bradykinin B2 antagonists should avoid its use.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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