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 injectable solution for subcutaneous use. It is indicated for the treatment of hereditary angioedema attacks in patients with confirmed diagnosis. The medication works by rapidly counteracting bradykinin‑mediated swelling, providing relief within minutes of administration.

GNH India supplies Icatibant Fresenius as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, transplant centres and specialty clinics worldwide, ensuring reliable cold‑chain logistics and regulatory compliance for this injectable therapy.

Manufacturer / TM Owner

Fresenius Kabi France S.A.S.

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Indications & Clinical Uses

Icatibant Fresenius is used to manage hereditary angioedema, a disorder characterized by excessive bradykinin activity.

  • Hereditary angioedema attacks: reduces swelling and pain by blocking bradykinin B2 receptors.
  • Hereditary angioedema type I: provides rapid symptom relief during acute episodes.
  • Hereditary angioedema type II: alleviates airway and peripheral edema during attacks.

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, thereby inhibiting the cascade that leads to localized swelling and pain during hereditary angioedema attacks. The blockade is dose‑dependent and reversible, allowing normal bradykinin signaling to resume as the drug is cleared.

Side Effects

Icatibant Fresenius may be associated with several adverse reactions following subcutaneous administration.

Common Side Effects

  • Injection site pain: mild to moderate discomfort at the injection site.
  • Redness or swelling: localized erythema or edema around the injection area.
  • Nausea: transient feeling of queasiness.
  • Headache: mild headache occurring shortly after dosing.
  • Dizziness: temporary light‑headedness.

Serious or Rare Side Effects

  • Hypersensitivity reactions: rash, urticaria, or anaphylaxis requiring immediate medical attention.
  • Angioedema of the throat: swelling that may compromise airway.
  • Severe hypotension: marked drop in blood pressure.
  • Thrombocytopenia: low platelet count observed in rare cases.

Precautions & Warnings

When prescribing Icatibant Fresenius, clinicians should consider several precautionary measures to ensure safe use.

  • Patient history: assess for known hypersensitivity to icatibant or its excipients.
  • Cardiovascular status: monitor patients with unstable blood pressure or cardiac disease.
  • Concomitant ACE inhibitors: evaluate risk of additive angioedema.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk.
  • Renal or hepatic impairment: no dosage adjustment required but monitor clinical response.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

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

Major Interactions (Avoid)

  • ACE inhibitors: may increase risk of angioedema when combined with icatibant.
  • Angiotensin receptor blockers (ARBs): similar risk of enhanced bradykinin‑mediated swelling.

Moderate Interactions (Monitor Closely)

  • Estrogen‑containing oral contraceptives: may potentiate bradykinin effects.
  • Other B2 receptor antagonists: additive pharmacodynamic effects.
  • CYP450 substrates: icatibant is not a major CYP inhibitor, but monitor for unexpected changes.

Frequently Asked Questions

Icatibant Fresenius is a prescription injectable indicated for the acute treatment of hereditary angioedema (HAE) attacks in patients with confirmed type I or type II disease. By blocking the bradykinin B2 receptor, it rapidly reduces swelling of the skin, gastrointestinal tract, and airway that characterizes HAE episodes.

Icatibant acetate is a competitive antagonist of the bradykinin B2 receptor on vascular endothelial cells. By occupying this receptor, it prevents bradykinin from triggering vasodilation and increased vascular permeability, which are responsible for the localized edema seen in hereditary angioedema. The effect is dose‑dependent and reversible as the drug is cleared.

The dosing regimen for Icatibant Fresenius is determined by the prescribing clinician based on the patient’s weight, severity of the attack, and clinical guidelines. Typically, a single subcutaneous injection is administered at the onset of an HAE attack, with additional doses allowed if symptoms persist, as directed by the healthcare professional.

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. Women who are pregnant, planning pregnancy, or breastfeeding should discuss treatment options with their physician, who can assess individual risk factors.

To place an order, visit the product page on gnhindia.com, enter the required quantity, and submit the enquiry form. 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 necessary import documentation.

Icatibant is a bradykinin B2 receptor antagonist, whereas other approved therapies such as C1‑esterase inhibitor concentrates replace the deficient protein, and newer monoclonal antibodies target upstream pathways. Icatibant offers rapid subcutaneous administration and fast symptom relief, but selection depends on patient preference, attack severity, and physician assessment of efficacy, safety, and convenience.

Icatibant Fresenius must be stored refrigerated between 2 °C and 8 °C. The product should be kept in its original packaging, protected from light, and must not be frozen or shaken. If temporary temperature excursions occur, the vial should be inspected for discoloration or particulate matter before use, and any deviation from recommended conditions should be reported to the supplier.

Icatibant is given by a single subcutaneous injection, usually into the abdomen or thigh. The injection site should be cleaned with an alcohol swab, and the pre‑filled syringe or vial is used according to the manufacturer’s instructions. Patients or caregivers can be trained to self‑administer, allowing prompt treatment at the first sign of an HAE attack.

The most serious adverse events include severe hypersensitivity reactions such as anaphylaxis, airway angioedema that may compromise breathing, and rare cases of profound hypotension. Prompt recognition of these symptoms and immediate medical intervention are essential. Patients should be educated to seek emergency care if they experience difficulty breathing, swelling of the throat, or a sudden drop in blood pressure after injection.

Icatibant is contraindicated in individuals with known hypersensitivity to icatibant acetate or any of its excipients. Caution is also advised for patients with a history of severe angioedema unrelated to hereditary forms, or those who have experienced anaphylactic reactions to similar biologic agents. In such cases, alternative therapies should be considered under medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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