Icatibant

What it is used for

Icatibant injection is a medicine used to treat acute attacks of hereditary angioedema (HAE) in adults 18 years and older. It is not known if icatibant injection is safe or effective for children under 18 years of age.

How to take it

• Use icatibant injection exactly as your healthcare provider tells you to use it.
• Your healthcare provider will prescribe the right dose of icatibant injection for you and tell you when to use it.
• Your healthcare provider will teach you or a caregiver how to give icatibant injections.
• Read the Instructions for Use at the end of the Patient Information for information about the right way to use icatibant injection.
• If your symptoms continue or come back, you may repeat your icatibant injection at least six hours apart.
• Do not use more than 3 doses in 24 hours.
• If you have a laryngeal attack, inject icatibant injection and then go to the nearest hospital emergency room right away.

Side effects, and when to stop

The most common side effects of icatibant injection include:

• redness, bruising, swelling, warmth, burning, itching, irritation, hives, numbness, pressure, or pain at the injection site
• fever
• too much of an enzyme called transaminase in your blood
• dizziness
• nausea
• headache
• rash

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of icatibant injection. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What to say before you start

Before you use icatibant injection, tell your healthcare provider if you:

• have any other medical conditions.
• are breastfeeding or plan to breastfeed. It is not known if icatibant injection passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use icatibant injection.
• are pregnant or plan to become pregnant. It is not known if icatibant injection will harm your unborn baby. You and your healthcare provider will decide if icatibant injection is right for you.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

What to avoid

Tiredness, drowsiness, and dizziness can occur in people who take icatibant injection. If this occurs, do not drive a car, use machinery, or do anything that needs you to be alert.

Storing it

• Store icatibant injection between 36°F to 77°F (2°C to 25°C).
• Do not freeze.
• Store icatibant injection in the original carton until you are ready to use it.

Keep icatibant injection and all medicines out of the reach of children.

General information about the safe and effective use of icatibant injection

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use icatibant injection for a condition for which it was not prescribed. Do not give icatibant injection to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about icatibant injection. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about icatibant injection that is written for health professionals.