Icatibant injection

Icatibant is used to treat attacks of hereditary angioedema (HAE; an inherited condition that causes episodes of swelling in the hands, feet, face, airway, or intestines) in adults. Icatibant is in a class of medications called bradykinin B2 receptor antagonists. It works by preventing the binding and therefore, action of bradykinin, a substance responsible for the symptoms of angioedema, in the body.

Icatibant injection comes as a liquid in a syringe to be given subcutaneously (under the skin). Icatibant injection is to be given in the stomach area at the start of HAE symptoms. It can be given again after 6 hours if symptoms do not go away or return. Icatibant cannot be given more than 3 times in 24 hours.

Your doctor or nurse or pharmacist will show you how to properly give icatibant injections. To use the icatibant injection, follow these steps:

1. Before using icatibant injection, inspect the liquid in the syringe carefully. The liquid should be clear and colorless and free of any particles.
2. Wash your hands with soap and water and then use an alcohol swab to clean the injection site. The injection site should be a fold of skin on your stomach, at least 2 to 4 inches from your belly button and 2 inches away from any scars.
3. Remove the protective cap from the end of the syringe by unscrewing it and then attach the needle to the end by screwing it on.
4. Remove the needle cap from the needle and hold the syringe firmly in on hand between the fingers and the thumb. With your other hand, pinch the area of skin cleaned for injection between your thumb and fingers.
5. Hold the needle at a 45 to 90 degree angle from the skin. Bring the needle to your skin, and quickly insert the needle and push the plunger at the top of the syringe slowly over at least 30 seconds.
6. Release the skin and pull the needle out.

If you have throat swelling as part of your symptoms before using icatibant, you should see a doctor at an emergency medical center immediately after injecting icatibant.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using icatibant,

• tell your doctor and pharmacist if you are allergic to icatibant, any other medications, or any of the ingredients in icatibant injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• you should know that icatibant may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you discover a pregnancy after receiving icatibant injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Icatibant injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• bruising, redness, swelling, warmth or pain at the site of injection
• fever
• dizziness
• nausea
• headache
• rash

Icatibant may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Keep the syringe in the carton it came in until ready for use.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. Make sure you always have a dose of icatibant available to you at all times.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Firazyr^®