Europe — EMA
Icatibant Universal Farma
GNH USA supplies Icatibant Universal Farma (Icatibant), a Bradykinin B2 receptor antagonist for acute hereditary angioedema attacks.
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What is Icatibant?
Icatibant, the active ingredient in Icatibant Universal Farma, is a Bradykinin B2 receptor antagonist presented as a subcutaneous injection for subcutaneous use. It treats acute attacks of hereditary angioedema in patients with confirmed HAE.
GNH USA supplies Icatibant Universal Farma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Icatibant used for?
Icatibant is used to treat conditions mediated by excessive bradykinin activity, primarily hereditary angioedema.
- Hereditary angioedema type I: Provides rapid relief of acute swelling episodes in patients with C1‑inhibitor deficiency. - Hereditary angioedema type II: Reduces edema and associated pain during acute attacks in patients with dysfunctional C1‑inhibitor. - Hereditary angioedema with normal C1‑inhibitor (HAE‑nC1‑INH): Controls sudden swelling attacks in patients with genetically confirmed HAE‑nC1‑INH.
What are the side effects of Icatibant?
Icatibant may cause a range of adverse reactions, most of which are related to the injection site or systemic response.
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 local 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: sudden drop in blood pressure. - Angioedema unrelated to HAE: unexpected swelling in other body parts. - Urticaria: widespread hives. - Severe injection‑site necrosis: tissue damage at the site. - Life‑threatening allergic reactions: including bronchospasm or throat swelling.
What precautions apply to Icatibant?
Before using Icatibant, clinicians should consider several safety measures.
- Confirm diagnosis: verify hereditary angioedema type before administration. - Monitor for hypersensitivity: observe patients for signs of allergic reaction after injection. - Evaluate cardiovascular status: caution in patients with unstable blood pressure. - Review concomitant medications: avoid concurrent use of ACE inhibitors when possible. - Pregnancy and lactation: assess risk‑benefit ratio; limited data are available. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Icatibant interact with?
Icatibant can interact with other drugs that influence bradykinin pathways or cardiovascular function.
Major Interactions (Avoid): - ACE inhibitors: increase bradykinin levels, potentially reducing Icatibant efficacy. - Estrogen‑containing contraceptives: may exacerbate angioedema frequency. - Other bradykinin antagonists: concurrent use may lead to unpredictable effects.
Moderate Interactions (Monitor Closely): - NSAIDs: may increase risk of gastrointestinal irritation. - Diuretics: monitor blood pressure and electrolyte balance. - Beta‑blockers: observe for altered cardiovascular response. - Antihistamines: may mask early signs of allergic reactions.
Frequently asked questions
What is Icatibant Universal Farma used for?+
How does Icatibant work?+
What is the usual dose of Icatibant?+
Is Icatibant safe during pregnancy or breastfeeding?+
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How does Icatibant compare with other HAE treatments?+
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Who should not use Icatibant?+
Product details
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