Product image of Icatibant Zentiva (Icatibant Acetate) supplied by GNH India

Icatibant Zentiva

Active Ingredient:
Icatibant Acetate
Origin:
EU

Icatibant Zentiva (Icatibant Acetate)

Icatibant acetate, the active ingredient in Icatibant Zentiva, is a bradykinin B2 receptor antagonist presented as a sterile solution for injection for subcutaneous use. It is indicated for the treatment of acute attacks of hereditary angioedema in adult patients, providing rapid reduction of swelling and associated discomfort.

GNH India supplies Icatibant Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide, delivering consistent quality and regulatory‑approved product for patients with hereditary angioedema. The product complies with EU marketing authorisation and is distributed under strict quality standards.

Manufacturer / TM Owner

Zentiva Italia S.R.L.

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Indications & Clinical Uses

  • Icatibant Zentiva is used to treat hereditary angioedema, a bradykinin‑mediated swelling disorder.
  • Hereditary angioedema type I: Provides rapid reduction of swelling, relieves pain, and shortens attack duration during acute episodes.
  • Hereditary angioedema type II: Provides rapid reduction of swelling, relieves pain, and shortens attack duration during acute episodes.
  • Hereditary angioedema with normal C1‑INH (HAE‑nC1INH): Offers symptom control and swelling reduction during acute attacks, though use may be off‑label in certain jurisdictions.

How It Works

  • Icatibant acetate selectively and competitively blocks the bradykinin B2 receptor on vascular endothelial cells. By preventing bradykinin binding, it inhibits downstream signaling that causes vasodilation and increased vascular permeability, thereby reducing fluid extravasation responsible for swelling in hereditary angioedema attacks. The antagonism is dose‑dependent and results in a swift reversal of the edema cascade without affecting other kinins.

Side Effects

Icatibant Zentiva may cause a range of adverse reactions, which are categorized by frequency.

Common Side Effects

  • Injection site pain
  • Erythema at the injection site
  • Local swelling
  • Nausea
  • Headache
  • Dizziness

Serious or Rare Side Effects

  • Hypersensitivity reactions including anaphylaxis
  • Severe hypotension
  • Airway angioedema
  • Thrombocytopenia
  • Injection‑site necrosis
  • Severe rash or Stevens‑Johnson syndrome

Precautions & Warnings

  • When prescribing Icatibant Zentiva, clinicians should consider several safety precautions.
  • Pregnancy: Use only if clearly needed; safety data are limited.
  • Breastfeeding: Caution; it is unknown whether the drug is excreted in human milk.
  • Renal impairment: No dose adjustment is required, but monitor for accumulation.
  • Concomitant ACE inhibitors or ARBs: May increase risk of bradykinin‑mediated angioedema; observe patients closely.
  • Hypersensitivity: Discontinue immediately if a severe allergic reaction occurs.
  • Store at 2-8°C: Keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Icatibant Zentiva can interact with other medicines that influence bradykinin pathways or vascular tone.

Major Interactions (Avoid)

  • ACE inhibitors: May potentiate bradykinin‑mediated angioedema.
  • Angiotensin receptor blockers (ARBs): Similar risk of enhanced angioedema.
  • Other bradykinin B2 antagonists: No additive benefit; avoid co‑administration.
  • Simultaneous use of prophylactic C1‑INH concentrate: May interfere with clinical assessment of efficacy.

Moderate Interactions (Monitor Closely)

  • NSAIDs: May increase risk of angioedema.
  • Estrogen‑containing contraceptives: Can exacerbate hereditary angioedema attacks.
  • Diuretics: May affect fluid balance during acute episodes.

Frequently Asked Questions

Icatibant Zentiva is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult patients. It works to quickly reduce swelling and associated discomfort caused by sudden episodes of HAE.

Icatibant acetate is a selective, competitive antagonist of the bradykinin B2 receptor. By blocking this receptor, it prevents bradykinin‑induced vasodilation and increased vascular permeability, which are the primary mechanisms driving the swelling seen in HAE attacks.

The dose of Icatibant Zentiva is determined by the prescribing healthcare professional based on the patient’s clinical condition, severity of the HAE attack, and relevant regulatory guidelines. No standardized dosing regimen is provided here; the prescriber sets the appropriate amount.

Safety data for icatibant acetate in pregnancy are limited, so it should only be used if the potential benefit justifies the potential risk to the fetus. During breastfeeding, it is unknown whether the drug is excreted in human milk, so caution is advised.

To order Icatibant Zentiva, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details (including cold‑chain where required) and import documentation.

Icatibant is a bradykinin B2 receptor antagonist, whereas other approved options include C1‑esterase inhibitor concentrates and recombinant C1‑INH. Icatibant acts directly on the bradykinin pathway, offering rapid symptom relief after subcutaneous injection, while C1‑INH products replace the deficient protein and are administered intravenously.

Icatibant Zentiva should be stored in a refrigerator at 2‑8 °C (36‑46 °F). Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking the solution. Do not store at ambient temperature for prolonged periods.

Icatibant Zentiva is supplied as a sterile solution for injection and is administered subcutaneously, typically into the abdomen or thigh. The injection is performed by a trained healthcare professional or by the patient after appropriate instruction.

Serious risks include hypersensitivity reactions such as anaphylaxis, severe hypotension, airway angioedema that can compromise breathing, thrombocytopenia, and injection‑site necrosis. Patients should be monitored closely after administration for any signs of these events.

Icatibant Zentiva should be avoided in individuals with known hypersensitivity to icatibant acetate or any excipients in the formulation. Caution is also advised for patients receiving ACE inhibitors, ARBs, or those with a history of severe angioedema unrelated to HAE.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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