Firazyr is used to treat attacks of hereditary angioedema (an immune system disorder) in adults.

Firazyr is not a cure for hereditary angioedema.

Firazyr may also be used for purposes not listed in this medication guide.

You should not use Firazyr if you are allergic to icatibant.

To make sure you can safely use this medicine, tell your doctor about all of your medical conditions, if you use heart or blood pressure medications, and if you are pregnant or breast-feeding.

Get emergency medical help if you have any swelling of your tongue or throat during an angioedema attack.

An allergic reaction to icatibant can cause symptoms that are very similar to the signs of hereditary angioedema, including: hives, trouble breathing, or swelling of your face, lips, tongue, or throat.

Do not use more than three Firazyr injections within a 24-hour period. Call your doctor if your symptoms do not improve, or if they get worse after using this medication.

Firazyr is injected under the skin. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Firazyr is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Wash your hands with soap and water before preparing your injection.

Prepare an injection only when you are ready to give it. Do not use the medicine if it has changed colors, looks cloudy, or has particles in it. Call your pharmacist for new medicine.

Do not inject Firazyr into an area that is painful, swollen, or bruised.

Use only the needle that is supplied with this medicine.

If you still have symptoms of angioedema after the first injection, you may use another injection after at least 6 hours have passed.

Inject Firazyr and get emergency medical help if you have any swelling of your tongue or throat during an angioedema attack.

Do not use more than 3 Firazyr injections within a 24-hour period.

Call your doctor if your symptoms do not improve, or if they get worse after using this medicine.

Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Store the prefilled syringe in its original container in a refrigerator or at room temperature. Do not freeze.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Hereditary Angioedema:

30 mg subcutaneously once, in the abdominal area; may repeat every 6 hours if response is inadequate or symptoms recur.

Maximum dose: 90 mg/day

Before using Firazyr tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding.

Older adults may be more sensitive to the effects of this medicine.

Firazyr is not approved for use by anyone younger than 18 years old.

Since Firazyr is used when needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using this medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include redness, itching, or feeling like you might pass out.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction to Firazyr: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

An allergic reaction to icatibant is unlikely to occur, but could cause symptoms that are very similar to the signs of hereditary angioedema.

Common Firazyr side effects may include:

• pain, numbness, bruising, redness, swelling, warmth, burning, irritation, hives, itching, or a feeling of pressure where the injection was given;

• drowsiness, tiredness;

• fever;

• headache, dizziness;

• abnormal liver function tests;

• nausea; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially heart or blood pressure medication.

Other drugs may interact with icatibant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.