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 solution for subcutaneous injection for subcutaneous use. 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 Ab

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Indications & Clinical Uses

Icatibant Fresenius is used to treat conditions involving bradykinin‑mediated vascular permeability, primarily hereditary angioedema.

  • Hereditary angioedema (HAE) with C1‑inhibitor deficiency: Provides rapid relief of acute swelling attacks by blocking the bradykinin B2 receptor.
  • Hereditary angioedema with normal C1‑inhibitor (HAE type III): Offers symptomatic control during episodic attacks.
  • Bradykinin‑mediated angioedema (off‑label): May reduce swelling by antagonising B2 receptors.

How It Works

  • Icatibant acetate acts as a competitive antagonist at the bradykinin B2 receptor on endothelial cells. By binding to this receptor, it prevents bradykinin from inducing vasodilation and increasing vascular permeability, thereby limiting the fluid extravasation that causes the 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

  • Anaphylaxis: severe allergic reaction requiring immediate medical attention.
  • Severe hypotension: marked drop in blood pressure.
  • Angioedema unrelated to HAE: unexpected swelling.
  • Urticaria: hives or skin rash.
  • Thrombocytopenia: low platelet count.
  • Severe allergic reaction: includes bronchospasm or facial swelling.

Precautions & Warnings

Before using Icatibant Fresenius, consider the following safety measures.

  • Pregnancy: safety not established; use only if benefit outweighs risk.
  • Breastfeeding: unknown safety; assess potential risks.
  • Renal impairment: no dosage adjustment required, but monitor renal function.
  • Concomitant ACE inhibitors or ARBs: may increase bradykinin levels; observe for angioedema.
  • Hypersensitivity: discontinue if severe allergic reaction occurs.
  • 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 affect the bradykinin pathway or cardiovascular system.

Major Interactions (Avoid)

  • ACE inhibitors: additive bradykinin effect may increase angioedema risk.
  • Angiotensin receptor blockers (ARBs): similar risk of enhanced bradykinin activity.
  • Other B2 receptor antagonists: may potentiate pharmacologic effects.

Moderate Interactions (Monitor Closely)

  • Diuretics: monitor blood pressure for additive hypotensive effect.
  • Antihistamines: may mask early signs of allergic reactions.
  • Corticosteroids: no direct interaction but monitor overall immune response.

Frequently Asked Questions

Icatibant Fresenius is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients who have a deficiency of C1‑inhibitor. By blocking the bradykinin B2 receptor, it helps reduce swelling and related symptoms during an HAE episode.

Icatibant acetate is a competitive antagonist of the bradykinin B2 receptor. It binds to this receptor on vascular endothelial cells, preventing bradykinin from causing vasodilation and increased vascular permeability, which are the primary mechanisms behind the swelling seen in HAE attacks.

The dose of Icatibant Fresenius is determined by the prescribing healthcare professional based on the patient’s condition and clinical guidelines. The medication is supplied as a solution for subcutaneous injection, and the prescriber will specify the exact amount and frequency for each individual.

The safety of Icatibant Fresenius in pregnancy and while breastfeeding has not been established. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and this decision must be made by a qualified healthcare provider.

To order Icatibant Fresenius, submit an enquiry on the product page at gnhindia.com, indicating the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain handling) and any necessary import documentation.

Icatibant is a bradykinin B2 receptor antagonist, whereas other HAE therapies such as C1‑inhibitor concentrates replace the deficient protein. Icatibant directly blocks the downstream mediator bradykinin, offering rapid symptom relief without the need for plasma‑derived products, but the choice of therapy depends on individual patient needs and physician judgment.

Icatibant Fresenius should be stored at 2‑8 °C (refrigerated). Keep the product in its original packaging, protect it from light, and do not freeze or shake the vial. If refrigeration is unavailable for a short period, it may be kept at controlled room temperature (up to 25 °C) for a limited time as specified in the product label.

Icatibant Fresenius is administered as a subcutaneous injection. The prescriber will instruct the patient or caregiver on the injection technique, including site selection (typically the abdomen or thigh), needle size, and any necessary aseptic precautions. The injection is usually given at the onset of an HAE attack.

Serious risks include anaphylaxis, severe hypotension, and unexpected angioedema unrelated to HAE. Patients should be monitored for signs of an allergic reaction, such as difficulty breathing, swelling of the face or throat, or a sudden drop in blood pressure, and seek immediate medical attention if these occur.

Icatibant Fresenius should not be used in individuals with a known hypersensitivity to icatibant acetate or any of the formulation excipients. Caution is also advised for patients receiving ACE inhibitors or ARBs due to the potential for increased bradykinin‑related angioedema. The prescriber will evaluate contraindications on a case‑by‑case basis.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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