What is it?

Firazyr is a solution for injection that contains the active substance icatibant.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Firazyr is used to treat the symptoms of attacks of hereditary angioedema in adults. Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain. Firazyr is used in patients whose angioedema is linked to naturally low levels of a protein called ?C1 esterase inhibitor?.

Because the number of patients who have angioedema is low, 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 it used?

Firazyr is given as a slow injection under the skin, preferably in the abdomen (tummy). The recommended dose of Firazyr is one injection. If symptoms continue or come back, a second injection can be given after six hours. If needed, treatment can be repeated for a third time after an additional six hours. No more than three injections should be given in any 24-hour period.

The doctor may decide that the patient or their caregiver can administer the medicine themselves, after they have been properly trained by a healthcare professional.

How does it work?

Patients with hereditary angioedema have high levels of a substance called ?bradykinin?, which is involved in causing inflammation and swelling. The active substance in Firazyr, icatibant, blocks the receptors that bradykinin normally attaches itself to. This blocks the activity of bradykinin, helping to relieve the symptoms of the disease.

How has it been studied?

Firazyr has been studied in two main studies in patients with angioedema of the skin or the abdomen. The first study compared Firazyr with tranexamic acid (another medicine for hereditary angioedema) in 74 patients, and the second study compared Firazyr with placebo (a dummy treatment) in 56 patients. The main measure of effectiveness was how long it took until the patient?s symptoms were relieved.

What benefits has it shown during the studies?

Firazyr was more effective than tranexamic acid and placebo in relieving the symptoms of the disease. In both studies, the time it took for the patient?s symptoms to improve was shorter for patients taking Firazyr than for those taking tranexamic acid or placebo. Patients experienced relief an average of 2.0 to 2.5 hours after receiving Firazyr, compared with 12.0 hours for tranexamic acid in one study and 4.6 hours for placebo in the other study.

What is the risk associated?

The most common side effects with Firazyr (seen in more than 1 patient in 10) are erythema (redness), swelling,, burning, itching and pain at injection sites. 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 to any of the other ingredients.

Why has it been approved?

The CHMP decided that Firazyr?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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