Icatibant is used to treat sudden attacks of a certain immune system condition passed down through families called hereditary angioedema (HAE). Although this medication is not a cure for HAE, icatibant may lessen the symptoms of an attack such as rapid swelling and pain of the hands, arms, feet, legs, face, tongue, and upper airway. When attacks involve the stomach/intestines, symptoms may include abdominal pain/cramps, diarrhea, constipation, or vomiting. Attacks may happen at any time. However, stress, injury, or illness may trigger attacks in some people.

Icatibant works by blocking the action of a natural substance in the body called bradykinin. Bradykinin is thought to cause the symptoms of an HAE attack.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using icatibant and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually over at least 30 seconds. The injection is given in the stomach/abdominal area. If your symptoms continue or come back, you may give another dose after at least 6 hours. Do not use more than 3 doses in 24 hours.

Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Learn how to store and discard medical supplies safely.

If you have a sudden HAE attack of your throat area/voice box/upper airway (larynx), give yourself an injection of icatibant and then get medical help right away. This type of attack may lead to a blocked airway and serious breathing trouble.

Tell your doctor if your symptoms do not get better or if they get worse.

Fever or dizziness may occur. Injection site reactions (such as redness, burning, swelling, bruising, irritation, pain) may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using icatibant, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Not applicable.

Store at room temperature or in the refrigerator. Do not freeze. Keep the medication in the original carton until ready to use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.