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 is indicated for the treatment of acute attacks of hereditary angioedema in patients with C1‑inhibitor deficiency, helping to reduce swelling and improve airway patency.

GNH India supplies Icatibant Fresenius as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑controlled sourcing and reliable cold‑chain logistics where required. The company adheres to stringent regulatory standards and provides comprehensive documentation for import and distribution.

Manufacturer / TM Owner

Fresenius Kabi Ab

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Indications & Clinical Uses

Icatibant Fresenius is used to manage hereditary angioedema, a bradykinin‑mediated swelling disorder.

  • Hereditary angioedema (C1‑inhibitor deficiency): rapidly reduces subcutaneous and submucosal swelling during acute attacks.
  • Hereditary angioedema (type I and II): provides symptom relief and improves airway patency.
  • Hereditary angioedema (off‑label prophylaxis): may be employed in selected cases to prevent recurrent episodes.

How It Works

  • Icatibant acetate selectively antagonizes the bradykinin B2 receptor on vascular endothelial cells. By blocking this receptor, it prevents bradykinin‑induced vasodilation and increased vascular permeability, which are responsible for the rapid swelling observed in hereditary angioedema. The inhibition of the B2 receptor thus curtails the cascade leading to edema formation, allowing restoration of normal vascular tone. The effect is localized to the site of injection and does not interfere with other kinins.

Side Effects

Icatibant Fresenius may be associated with several adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Injection site pain: mild to moderate discomfort at the injection site.
  • Redness or swelling at injection site: localized erythema.
  • Nausea: transient feeling of queasiness.
  • Headache: mild headache occurring after administration.
  • Flushing: temporary warmth and reddening of skin.

Serious or Rare Side Effects

  • Hypersensitivity reactions: rash, urticaria, or anaphylaxis.
  • Severe injection site necrosis: tissue damage at the site.
  • Thrombocytopenia: low platelet count observed in rare cases.
  • Acute hypotension: sudden drop in blood pressure.
  • Angioedema of the face or airway unrelated to hereditary condition (very rare).

Precautions & Warnings

When using Icatibant Fresenius, several precautions should be observed to ensure safe administration.

  • Patient assessment: verify diagnosis of hereditary angioedema and C1‑inhibitor status before use.
  • Contraindications: avoid in patients with known hypersensitivity to icatibant acetate or any formulation components.
  • Monitoring: observe for signs of allergic reaction during and after injection.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk; data are limited.
  • Concomitant therapy: evaluate interactions with other bradykinin‑targeting agents.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Icatibant Fresenius can interact with other medicines; awareness of these interactions helps prevent adverse outcomes.

Major Interactions (Avoid)

  • ACE inhibitors: may increase bradykinin levels, potentially reducing icatibant efficacy.
  • Angiotensin receptor blockers (ARBs): similar risk of altered bradykinin dynamics.

Moderate Interactions (Monitor Closely)

  • Estrogen‑containing oral contraceptives: may affect angioedema frequency.
  • Other B2 receptor antagonists: additive pharmacologic effect.
  • Antihistamines: may mask early signs of hypersensitivity.

Frequently Asked Questions

Icatibant Fresenius contains icatibant acetate, a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients with C1‑inhibitor deficiency. By blocking the effects of bradykinin, the medication helps to rapidly reduce swelling of the skin, gastrointestinal tract, and airway that can occur during HAE episodes.

Icatibant acetate selectively binds to the bradykinin B2 receptor on vascular endothelial cells, preventing bradykinin from activating the receptor. This inhibition stops the cascade that leads to vasodilation and increased vascular permeability, which are responsible for the rapid edema seen in hereditary angioedema. The result is a swift reduction in swelling without affecting other kinins.

The dose of Icatibant Fresenius is determined by the prescribing clinician based on the patient’s condition, severity of the attack, and clinical guidelines. The medication is administered as a subcutaneous injection, and the prescriber decides the exact amount, frequency, and any repeat dosing required for optimal therapeutic effect.

Safety data for icatibant acetate in pregnancy and lactation are limited. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant. Healthcare providers should discuss the lack of extensive studies and consider alternative treatments when appropriate.

To request Icatibant Fresenius, 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 handling if needed—and assistance with import documentation.

Icatibant is a selective bradykinin B2 receptor antagonist, whereas other HAE therapies include C1‑inhibitor concentrates and kallikrein inhibitors. Icatibant acts downstream of the bradykinin pathway, offering rapid symptom relief after subcutaneous injection, while C1‑inhibitor products replace the deficient protein intravenously. Choice of therapy depends on patient preference, attack severity, and clinical response.

Icatibant Fresenius should 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 storage at room temperature is unavoidable, limit exposure to no more than 30 days and return the product to refrigeration as soon as possible.

The medication is supplied as a sterile injection solution for subcutaneous use. A healthcare professional or trained patient injects the prescribed volume into the subcutaneous tissue, typically in the abdomen or thigh, using a sterile needle. The injection site should be rotated for repeated doses, and the patient should be observed for any immediate adverse reactions.

The most serious risks include hypersensitivity reactions such as rash, urticaria, or anaphylaxis, and rare cases of severe injection‑site necrosis or thrombocytopenia. Patients should be monitored closely after administration, and any signs of severe allergic response, uncontrolled swelling, or unexpected bleeding should prompt immediate medical evaluation.

Icatibant Fresenius is contraindicated in individuals with known hypersensitivity to icatibant acetate or any excipients in the formulation. It should also be avoided in patients who have experienced severe allergic reactions to other bradykinin B2 receptor antagonists. Clinicians must assess each patient’s medical history before prescribing the medication.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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