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

Icatibant Sandoz

Active Ingredient:
Icatibant
Origin:
EU

Icatibant Sandoz (Icatibant)

Icatibant, the active ingredient in Icatibant Sandoz, is a bradykinin B2 receptor antagonist presented as a solution for injection for subcutaneous use. It treats acute attacks of hereditary angioedema type I and type II in patients with this condition.

GNH India supplies Icatibant Sandoz as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Sandoz A/S

1
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Indications & Clinical Uses

Icatibant is indicated for the treatment of hereditary angioedema, a condition mediated by excessive bradykinin activity.

  • Acute attacks of hereditary angioedema type I: provides rapid reduction of subcutaneous and submucosal swelling by competitively inhibiting the bradykinin B2 receptor.
  • Acute attacks of hereditary angioedema type II: achieves symptom relief and limits airway obstruction by blocking bradykinin‑mediated vascular permeability.

How It Works

  • Icatibant is a synthetic decapeptide that acts as a selective, competitive antagonist of the bradykinin B2 receptor. By binding to this G‑protein‑coupled receptor, it prevents bradykinin from inducing vasodilation and increasing vascular permeability, thereby interrupting the cascade that leads to the swelling characteristic of hereditary angioedema. The blockade is rapid and reversible, allowing restoration of normal vascular tone during an acute attack.

Side Effects

Icatibant may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Injection site pain: mild to moderate discomfort at the subcutaneous injection site.
  • Redness or swelling at injection site: localized erythema or edema.
  • Nausea: transient feeling of queasiness.
  • Headache: mild headache occurring shortly after administration.
  • Fever: low‑grade temperature increase.
  • Dizziness: transient light‑headedness.

Serious or Rare Side Effects

  • Hypersensitivity reactions: including rash, urticaria, or anaphylaxis requiring immediate medical attention.
  • Severe hypotension: rare drop in blood pressure following injection.
  • Thrombocytopenia: very rare decrease in platelet count.
  • Liver enzyme elevation: rare increase in transaminases.
  • Angioedema of the airway: potentially life‑threatening swelling requiring emergency care.

Precautions & Warnings

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

  • Renal impairment: monitor for accumulation as clearance may be reduced.
  • Hepatic dysfunction: use with caution; limited data on safety.
  • Pregnancy: safety not established; avoid unless benefit outweighs risk.
  • Breastfeeding: unknown excretion; consider alternatives.
  • Concomitant ACE inhibitors: may increase bradykinin levels, raising risk of angioedema.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Icatibant can interact with other medicines that influence bradykinin pathways or affect its pharmacokinetics.

Major Interactions (Avoid)

  • ACE inhibitors: may increase bradykinin levels, raising risk of angioedema.
  • Angiotensin receptor blockers (ARBs): similar risk of enhanced bradykinin effects.
  • DPP‑4 inhibitors: potential additive effect on bradykinin metabolism.

Moderate Interactions (Monitor Closely)

  • NSAIDs: may exacerbate swelling if angioedema occurs.
  • C1‑esterase inhibitor concentrates: concurrent use may not provide additional benefit; monitor clinical response.

Frequently Asked Questions

Icatibant Sandoz is used to treat acute attacks of hereditary angioedema type I and type II. By blocking the bradykinin B2 receptor, it rapidly reduces swelling of the skin, mucosa, and airway that can occur during an attack.

Icatibant is a selective, 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 hereditary angioedema.

The dose of Icatibant Sandoz is determined by the prescribing healthcare professional based on the patient’s condition and clinical response. It is administered as a subcutaneous injection, and the prescriber will specify the exact amount and timing for each acute episode.

Safety of Icatibant in pregnancy and lactation has not been established. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and the decision should be made by a qualified healthcare provider.

To order Icatibant Sandoz, submit an enquiry on the product page at gnhindia.com with 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 where required) and any necessary import documentation.

The primary alternative class is C1‑esterase inhibitor concentrates, which replace the deficient protein in hereditary angioedema. Icatibant works upstream by blocking bradykinin receptors, offering a rapid subcutaneous option, whereas C1‑esterase inhibitors are given intravenously or subcutaneously and act by restoring regulatory control of the complement system.

Icatibant Sandoz should be stored at 2‑8 °C (refrigerated). Keep the vial in its original packaging, protect it from light, and do not freeze or shake the solution. If temporary storage at room temperature is unavoidable, limit exposure to less than 30 °C for no more than 24 hours.

Icatibant is administered by subcutaneous injection, typically into the abdomen or thigh. The injection site should be cleaned with an alcohol swab, and the solution should be injected slowly using the supplied pre‑filled syringe or vial, following the prescriber’s instructions.

Serious risks include hypersensitivity reactions such as rash, urticaria, or anaphylaxis, and rare events like severe hypotension, airway angioedema, thrombocytopenia, and liver enzyme elevations. Patients should seek immediate medical attention if they experience difficulty breathing, swelling of the face or throat, or any signs of an allergic reaction.

Icatibant should not be used by individuals with a known hypersensitivity to icatibant or any of the excipients in the formulation. Caution is also advised for patients receiving ACE inhibitors or ARBs, as the combined effect on bradykinin may increase the risk of angioedema.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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