Firazyr - icatibant

What is Firazyr?

Firazyr is a solution for injection containing the active substance icatibant.

What is Firazyr used for?

Firazyr is used to treat the symptoms of attacks of hereditary angioedema in adults. Patients with angioedema suffer from swellings that can affect any part of the body, such as the face, limbs or abdominal region, causing illness and pain. The term "hereditary" indicates that the disease is caused by the patient's genes. Firazyr is used in patients whose angioedema is due to naturally low levels of a protein called C1 esterase inhibitor.

Given the small number of patients with hereditary angioedema, the disease is considered rare and Firazyr was designated an "orphan medicine" (a medicine used in rare diseases) on 17 February 2003.

The medicine can only be obtained with a prescription.

How is Firazyr used?

Firazyr is given as a slow subcutaneous injection by a doctor or nurse, preferably in the abdomen. The recommended dose of Firazyr is an injection. If the symptom persists or returns, a second injection can be given after six hours. If necessary, the treatment can be repeated a third time after another six hours. It is recommended not to exceed three injections over a 24-hour period. Firazyr has not been tested on children.

How does Firazyr work?

Patients with hereditary angioedema have a high level of a substance called bradykinin, which is a factor in inflammation and swelling. The active ingredient present in Firazyr, the icatibant, blocks the receptors to which bradykinin normally attaches. This inhibits the activity of bradykinin, alleviating the symptoms of the disease.

What studies have been carried out on Firazyr?

The effects of Firazyr were first analyzed in experimental models before being studied in humans.

Firazyr has been studied in two main studies in patients with angioedema of the skin or abdomen. The first study compared Firazyr to tranexamic acid (another medicine used for this disease) in 74 patients, and the second study compared Firazyr with a placebo (a dummy treatment) in 56 patients. The main measure of effectiveness was how long it took to get an improvement in the patient's symptoms.

What benefit has Firazyr shown during the studies?

Firazyr was more effective than tranexamic acid and placebo in controlling the symptoms of the disease. In both studies, the time needed to achieve symptom improvement was shorter for patients taking Firazyr than for those taking tranexamic acid or placebo. On average, patients experienced relief 2-2.5 hours after Firazyr administration, compared with 12 hours after taking tranexamic acid and 4.6 hours after placebo.

What is the risk associated with Firazyr?

The most common side effects seen from taking Firazyr (seen on more than 1 in 10 patients) are: erythema (redness), swelling, sensation of heat, burning, itching and pain. For the full list of all side effects reported with Firazyr, see the Package Leaflet.

Firazyr should not be used in people who may be hypersensitive (allergic) to icatibant or any of the other ingredients.

Why has Firazyr been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Firazyr's benefits are greater than its risks for the symptomatic treatment of acute attacks of hereditary angioedema in adults. Therefore, the Committee recommended that Firazyr be given marketing authorization.