• Firazyr is a brand (trade) name for icatibant which may be used to treat attacks of hereditary angioedema (HAE) in adults.
• Firazyr works by blocking the binding of bradykinin to the bradykinin B2 receptor. Bradykinin is a vasodilator that increases blood vessel permeability and is thought to be responsible for the characteristic HAE symptoms such as localized swelling, inflammation, and pain. By blocking the B2 receptor, Firazyr prevents bradykinin from binding to the receptor, which helps to relieve the symptoms of HAE.
• Firazyr belongs to the class of medicines known as bradykinin B2 receptor inhibitors. It may also be called a hereditary angioedema agent.

• May be used to treat acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adults.
• Reduces swelling in the limbs, face, intestinal tract, and airway.
• Firazyr is given by subcutaneous injection (under the skin).
• Firazyr may be administered by a health professional or people can be taught to self-administer it.
• The usual dosage to treat an acute attack of angioedema is 30mg. If attack symptoms persist additional doses may be administered at intervals of at least 6 hours. No more than 3 doses may be administered in a 24-hour period.
• No hypersensitivity or anaphylactic reactions have been reported with Firazyr.
• Although there does seem to be a potential for antibody formation, there has been no association between antibody formation and poor efficacy.
• Can be kept in the refrigerator or at room temperature; store between 2-25°C (36-77°F). Do not freeze. Keep in the original carton until you need to use it.
• Available as a prefilled syringe containing 30mg Firazyr (icatibant).
• There are no documented contraindications to using Firazyr.
• Causes few side effects.
• No dosage adjustment is required in people with mild-to-moderate liver or kidney disease. Firazyr is cleared non-renally so is not expected to be a problem in people with renal impairment.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Injection site reactions (pain, swelling, redness, or itch at the site of the injection) have been reported by 97% of people administered Firazyr. Fever, an increase in transaminase levels, and drowsiness and dizziness have been reported by less than 5% of people. Other side effects are uncommon.
• People self-administering Firazyr for acute laryngeal HAE attacks require follow-up medical attention in an appropriate healthcare facility or emergency department because these can be life-threatening.
• Not to be used for the prevention of HAE. Other medications, such as Haegarda, do this.
• Not to be administered to children and young adults under the age of 18.
• No generic is available.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• You can be taught how to self-administer Firazyr at home. It is given by subcutaneous injection (which means just under the skin) into your abdominal (stomach) area. A nurse or doctor should teach you how to self-administer Firazyr before you try yourself alone.
• First, wash your hands with soap and water. Decide where you will inject the Firazyr; choose an area that is free from scars or is not bruised or painful at least 2 to 4 inches below your belly button on either side. Clean the injection site with an alcohol swab and allow it to dry. Remove the prefilled syringe from the carton and remove the seal from the needle cap. Inspect the contents of the syringe. They should be clear and colorless. Do not use the injection if it contains particles, is cloudy, or has an unusual color. Remove the protective cap from the end of the prefilled syringe by unscrewing the cap. Hold the syringe firmly and firmly screw the needle to the prefilled syringe containing the Firazyr. Hold the needle cap and remove the needle and syringe. Do not touch the plunger.
• Hold the injection like a pen and use your other hand to gently pinch the skin up on your injection site into a fold. Inject the needle into the skin fold at a 45 to 90-degree angle. Push the plunger slowly, releasing the Firazyr into the skin over at least 30 seconds. Release the skin fold and pull the needle out. Dispose of your used Firazyr syringe into an appropriate sharps container.
• The usual dosage to treat an acute attack of angioedema is 30mg, which is one prefilled syringe. If attack symptoms persist or recur you can give yourself another injection after 6 hours. But do not administer more than 3 doses in 24 hours.
• Your healthcare provider can also administer Firazyr for you.
• Although Firazyr is a treatment for acute angioedema attacks, it is important to know that laryngeal (throat) attacks can become life-threatening. If you have an HAE attack involving the throat, inject Firazyr as directed and then go to the nearest hospital emergency room right away.
• Injection site reactions are the main side effect of Firazyr, but it can also cause dizziness, drowsiness, or tiredness in some people. If you are affected, do not drive or operate machinery until the effects of Firazyr have worn off. Talk to your healthcare provider if you develop any unusual or severe side effects.
• Talk to your healthcare provider about the risk of administering this drug during pregnancy or while breastfeeding. Available data for pregnant women have not indicated an increased risk of birth defects, or adverse maternal or fetal outcomes. There is no data about the use of Firazyr during breastfeeding but animal studies indicate that it does pass into animal milk. However, Firazyr is not expected to be absorbed by infants after oral exposure. Your healthcare provider should weigh up the risks vs benefits before using Firazyr if you are pregnant or breastfeeding.

• In clinical trials, it took an average of 2 to 2.5 hours for Firazyr (icatibant) to relieve symptoms of angioedema in people with HAE.
• 92.4% of attacks were treated with a single dose of Firazyr.
• Firazyr was used to treat acute HAE attacks of the throat in 60 people. Symptom reduction was similar to results seen for skin and abdominal attacks.
• When injected under the skin (subcutaneously), 97% of a dose of Firazyr is absorbed into the bloodstream. It takes approximately 45 minutes for Firazyr to reach peak levels in the blood.
• Firazyr has a short half-life (approximately 1.4 hours) and most of the dose is eliminated after 5.6 to 7 hours. There is no evidence of accumulation of Firazyr after three 30mg doses administered 6 hours apart. One subcutaneous 30mg dose of Firazyr effectively blocks bradykinin for a least six hours (up to eight hours).

Medicines that interact with Firazyr may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Firazyr. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Firazyr include:

• ACE inhibitors, such as captopril, enalapril, or lisinopril (Firazyr may enhance the antihypertensive effect of ACE inhibitor because it blocks bradykinin B2 receptors)
• ACE inhibitor combinations, such as enalaprilat.

Note that this list is not all-inclusive and includes only common and known medications that may interact with Firazyr. You should refer to the prescribing information for Firazyr for a complete list of interactions.