GNH USA

Europe — EMA

Icatibant Fresenius (Icatibant Acetate)

GNH USA supplies Icatibant Fresenius (Icatibant acetate), a bradykinin B2 receptor antagonist for hereditary angioedema attacks.

Icatibant Acetate

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What is Icatibant Acetate?

Icatibant acetate, the active ingredient in Icatibant Fresenius, is a bradykinin B2 receptor antagonist presented as a subcutaneous formulation for subcutaneous use. It treats acute attacks of hereditary angioedema in patients with C1‑inhibitor deficiency. GNH USA supplies Icatibant Fresenius as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Icatibant Acetate used for?

Icatibant Fresenius is used to manage conditions driven by excessive bradykinin activity, especially hereditary angioedema. - Hereditary angioedema type I attacks: Rapid reduction of swelling and associated pain. - Hereditary angioedema type II attacks: Prompt relief of edema and restoration of airway patency. - Hereditary angioedema with normal C1‑inhibitor: Accelerates resolution of acute swelling episodes.

What are the side effects of Icatibant Acetate?

Icatibant Fresenius may cause a range of adverse reactions following subcutaneous administration.

Common Side Effects: - Injection site erythema: Redness at the injection site. - Injection site pain: Localized discomfort after dosing. - Injection site swelling: Mild to moderate edema around the needle entry. - Nausea: Transient feeling of queasiness. - Headache: Mild to moderate head pain.

Serious or Rare Side Effects: - Anaphylactic reaction: Rapid onset of systemic hypersensitivity requiring emergency care. - Severe hypotension: Marked drop in blood pressure that may lead to dizziness or syncope. - Laryngeal edema: Swelling of the throat that can compromise airway patency. - Stevens‑Johnson syndrome: Rare severe skin reaction with blistering and detachment.

What precautions apply to Icatibant Acetate?

Before using Icatibant Fresenius, consider the following safety measures. - Renal impairment: Monitor renal function and adjust therapy if needed. - Hepatic impairment: Use with caution in patients with liver disease. - Pregnancy: Safety not established; prescribe only if benefit outweighs potential risk. - Breastfeeding: Unknown excretion in milk; evaluate risk versus benefit. - Concomitant ACE inhibitors: May increase bradykinin levels and risk of angioedema. - Store at 2-8°C: Keep refrigerated, protect from light, do not freeze or shake.

What does Icatibant Acetate interact with?

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

Major Interactions (Avoid): - ACE inhibitors: Heightened risk of angioedema; avoid co‑administration. - Angiotensin II receptor blockers (ARBs): May augment bradykinin effects; avoid. - Estrogen‑containing contraceptives: Can exacerbate hereditary angioedema; avoid.

Moderate Interactions (Monitor Closely): - C1‑inhibitor concentrates: Potential reduction in therapeutic effect; monitor response. - Other bradykinin‑targeting agents: Additive pharmacodynamic effect; observe for excessive hypotension. - Non‑steroidal anti‑inflammatory drugs (NSAIDs): May increase local injection‑site reactions; watch for irritation.

Frequently asked questions

What is Icatibant Fresenius used for?+
Icatibant Fresenius is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients with C1‑inhibitor deficiency or normal C1‑inhibitor function. It helps to quickly reduce swelling, pain, and the risk of airway obstruction during an HAE episode.
How does icatibant acetate work?+
Icatibant acetate is a selective antagonist of the bradykinin B2 receptor. By blocking this receptor on vascular endothelial cells, it prevents bradykinin‑mediated vasodilation and increased vascular permeability, thereby limiting the formation of edema that characterises hereditary angioedema attacks.
What is the usual dose of Icatibant Fresenius?+
The dose is determined by the prescribing healthcare professional based on the patient’s clinical condition and local guidelines. Typically, a single subcutaneous injection is administered at the onset of an HAE attack, with additional doses considered only if the response is insufficient.
Is Icatibant Fresenius safe in pregnancy or breastfeeding?+
Safety data in pregnancy and lactation are limited. The product should be used only if the potential benefit justifies any potential risk to the fetus or infant, and the decision should be made in consultation with a qualified healthcare provider.
How do I order Icatibant Fresenius from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details (including cold‑chain where applicable) and import documentation.
How does Icatibant compare with the main alternative therapy for HAE?+
The primary alternative is C1‑inhibitor concentrate, which replaces the deficient protein. Icatibant works by blocking the downstream bradykinin receptor, offering a rapid, protein‑free option that can be self‑administered subcutaneously. Choice of therapy depends on patient preference, attack severity, and clinical guidelines.
What are the storage and handling requirements for Icatibant Fresenius?+
Icatibant Fresenius must be stored refrigerated at 2‑8 °C. Keep the product in its original packaging, protect it from light, and do not freeze or shake the vial. If temporary temperature excursions occur, follow the manufacturer’s guidance before use.
How is Icatibant Fresenius administered?+
The medication is given as a subcutaneous injection, usually into the abdomen or thigh. The injection site should be cleaned with an alcohol swab, and the needle inserted at a 45‑ to 90‑degree angle depending on the patient’s subcutaneous tissue thickness. Patients should be trained on proper technique by a healthcare professional.
What are the most serious risks to watch for when using Icatibant?+
Serious adverse events include anaphylaxis, severe hypotension, and laryngeal edema that can compromise the airway. Patients should be instructed to seek immediate medical attention if they experience difficulty breathing, swelling of the throat, sudden drop in blood pressure, or signs of a severe allergic reaction.
Who should not use Icatibant Fresenius?+
Icatibant Fresenius is contraindicated in individuals with a known hypersensitivity to icatibant acetate or any of the excipients in the formulation. It should also be avoided in patients for whom acute HAE treatment is not indicated, unless a prescriber determines a clear therapeutic benefit.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.
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Product details

Drug
Icatibant Acetate
Route
Subcutaneous Use
Manufacturer
Fresenius Kabi Polska Sp. Z O.O.
Origin
EU

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