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 a subcutaneous injection for subcutaneous use. It treats acute attacks of hereditary angioedema in patients with C1‑inhibitor or factor XII deficiency. It is indicated for rapid symptom relief and reduction of swelling associated with hereditary angioedema attacks.

GNH India supplies Icatibant Fresenius as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company ensures quality assurance, regulatory compliance, and reliable cold‑chain logistics for this injectable therapy.

Manufacturer / TM Owner

Fresenius Kabi Nederland B.V.

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Indications & Clinical Uses

Icatibant is used to treat hereditary angioedema by blocking the bradykinin pathway.

  • Acute hereditary angioedema (C1‑inhibitor deficiency): rapid reduction of swelling and pain.
  • Acute hereditary angioedema (factor XII deficiency): rapid reduction of swelling and pain.
  • Hereditary angioedema attacks in adults: relief of symptoms and restoration of normal function.

How It Works

  • Icatibant acts as a competitive antagonist at the bradykinin B2 receptor on vascular endothelial cells. By binding to this receptor, it prevents bradykinin‑induced vasodilation and increased vascular permeability, thereby inhibiting the cascade that leads to edema formation during hereditary angioedema attacks. The blockade is selective and reversible, allowing normal physiological signaling to resume after the drug is cleared. This targeted action reduces the severity and duration of swelling without affecting other kinins.

Side Effects

Icatibant may cause a range of adverse reactions, varying from mild to serious.

Common Side Effects

  • Injection site pain: mild to moderate discomfort at the injection site.
  • Redness or swelling at injection site: localized erythema.
  • Nausea: occasional feeling of queasiness.
  • Headache: transient headache episodes.
  • Flushing: brief warmth or redness of skin.

Serious or Rare Side Effects

  • Hypersensitivity reactions: rash, itching, or anaphylaxis.
  • Severe abdominal pain: persistent or worsening abdominal discomfort.
  • Thrombocytopenia: low platelet count observed in rare cases.

Precautions & Warnings

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

  • Patient assessment: confirm diagnosis of hereditary angioedema and appropriate indication.
  • Contraindications: avoid use in patients with known hypersensitivity to icatibant or any excipients.
  • Monitoring: observe for signs of allergic reaction during and after injection.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk, as safety data are limited.
  • Concomitant therapy: assess for interactions with ACE inhibitors or other bradykinin‑modulating agents.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Icatibant can interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • ACE inhibitors: may increase bradykinin levels and heighten risk of angioedema.
  • Angiotensin receptor blockers (ARBs): similar risk of enhanced bradykinin‑mediated effects.

Moderate Interactions (Monitor Closely)

  • Estrogen‑containing contraceptives: may exacerbate hereditary angioedema severity.
  • DPP‑4 inhibitors: potential additive effect on bradykinin metabolism.
  • Other B2 receptor antagonists: may alter therapeutic response.

Frequently Asked Questions

Icatibant Fresenius is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients with C1‑inhibitor or factor XII deficiency. By rapidly blocking the bradykinin B2 receptor, it helps to reduce swelling, pain, and other symptoms associated with an HAE episode.

Icatibant is a competitive antagonist of the bradykinin B2 receptor on vascular endothelial cells. By occupying this receptor, it prevents bradykinin‑induced vasodilation and increased vascular permeability, which are key steps in the formation of edema during hereditary angioedema attacks.

The dose of icatibant is determined by the prescribing clinician based on the patient’s condition, weight, and clinical response. Typically, a single subcutaneous injection is administered at the onset of an HAE attack, and additional doses may be given if needed, following the prescriber’s instructions.

Safety data for icatibant 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, and the decision should be made by a qualified healthcare professional.

To order 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), and any necessary import documentation.

The primary alternative to icatibant is plasma‑derived or recombinant C1‑inhibitor concentrate, which replaces the deficient protein. Icatibant directly blocks the bradykinin B2 receptor, offering a rapid, self‑administered subcutaneous option, whereas C1‑inhibitor products are given intravenously and act upstream in the cascade.

Icatibant 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 °C for a short period, as recommended by the manufacturer.

Icatibant is administered by subcutaneous injection, usually into the abdomen or thigh. The injection can be performed by the patient or a caregiver after appropriate training. The device is a pre‑filled syringe or autoinjector, and the site should be rotated to minimize local irritation.

Serious adverse reactions include hypersensitivity events such as rash, itching, or anaphylaxis, as well as severe abdominal pain and rare cases of thrombocytopenia. Patients should be instructed to seek immediate medical attention if they experience any signs of a severe allergic reaction or unexplained, worsening abdominal discomfort.

Icatibant is contraindicated in individuals with a known hypersensitivity to icatibant or any of its excipients. Caution is also advised for patients receiving ACE inhibitors or ARBs, as the combined effect on bradykinin may increase the risk of angioedema. Pregnant or nursing women should only use it when clearly indicated by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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