Firazyr
Evidence Grade A — Regulatory approved. 759 published studies. 32 registered clinical trials.
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Icatibant (sold as Firazyr) is a self-injectable rescue treatment for sudden swelling attacks in hereditary angioedema (HAE) — a rare genetic condition that causes unpredictable episodes of severe swelling in the face, throat, hands, feet, or abdomen. It works by blocking the molecule (bradykinin) directly responsible for the swelling, typically providing noticeable relief within about two hours.
759 published studies: 434 human, 215 animal, 53 in-vitro, 150 reviews
Icatibant is marketed as Firazyr (approved August 2011) for the treatment of acute hereditary angioedema attacks in adults. It is self-administered as a subcutaneous injection from a prefilled syringe.
In clinical trials, icatibant provided symptom relief in a median of 2 hours compared to nearly 20 hours for placebo, with most patients experiencing significant improvement from a single injection. Generic icatibant has become available, improving access. The self-injection format is a significant practical advantage for a condition where swelling attacks are unpredictable and can become life-threatening if the airway is involved — patients can carry and administer the medication immediately without waiting for hospital treatment.
In hereditary angioedema, a missing protein (C1-inhibitor) leads to excessive production of bradykinin, a small molecule that makes blood vessel walls leak fluid into surrounding tissues, causing rapid and sometimes life-threatening swelling. Icatibant is a modified version of bradykinin itself — redesigned with five non-natural amino acids that convert it from an activator to a blocker of the bradykinin B2 receptor. It competitively occupies the receptor, preventing bradykinin from triggering the vascular leakage that causes swelling.
Clinical trials showed icatibant provided symptom relief in a median of 2 hours, compared to nearly 20 hours with placebo. The ability for patients to carry and self-inject the medication from a prefilled syringe is particularly important for a condition where attacks are unpredictable and throat swelling can be life-threatening — waiting for hospital treatment is not always feasible. Generic icatibant has become available, improving access for this rare disease population. Injection-site reactions occur in virtually all patients (97%) but are generally mild and short-lived. A trial investigating icatibant for ACE-inhibitor-related angioedema (a more common type of swelling) was terminated without conclusive results. No direct comparison trials exist between icatibant and the other HAE attack treatments (ecallantide or C1-inhibitor concentrate).
AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study
A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks
A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People
A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema
A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China
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