Icatibant

Icatibant is used for:

Treating sudden attacks of hereditary angioedema (HAE). It may also be used for other conditions as determined by your doctor.

Icatibant is a bradykinin B2 receptor blocker. It works by blocking bradykinin, a substance which is thought to be responsible for the HAE symptoms of swelling, inflammation, and pain.

Do NOT use Icatibant if:

• you are allergic to any ingredient in Icatibant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Icatibant:

Some medical conditions may interact with Icatibant. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Icatibant. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Angiotensin converting enzyme (ACE) inhibitors (eg, lisinopril) because their effectiveness may be decreased by Icatibant

This may not be a complete list of all interactions that may occur. Ask your health care provider if Icatibant may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Icatibant:

Use Icatibant as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Icatibant. Talk to your pharmacist if you have questions about this information.
• Icatibant may be given as an injection at your doctor's office, hospital, or clinic. If you will be using Icatibant at home, a health care provider will teach you how to use it. Be sure you understand how to use Icatibant. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
• Do not use Icatibant if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• If your symptoms continue, or if they go away and then come back, you may use another dose of Icatibant as directed by your doctor. Wait at least 6 hours between doses.
• Do not use more than 3 doses in a 24 hour period.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you are unable to use your dose of Icatibant, seek immediate medical attention.

Ask your health care provider any questions you may have about how to use Icatibant.

Important safety information:

• Icatibant may cause dizziness, drowsiness, or tiredness. These effects may be worse if you take it with alcohol or certain medicines. Use Icatibant with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• If you have an HAE attack that includes your throat (laryngeal attack), use Icatibant and then seek immediate medical attention. Symptoms of a laryngeal attack may include swelling of the mouth, face, lips, throat, or tongue; difficulty swallowing; shortness of breath or trouble breathing; wheezing; or unusual hoarseness. Discuss any questions or concerns with your doctor.
• Icatibant should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Icatibant while you are pregnant. It is not known if Icatibant is found in breast milk. If you are or will be breast-feeding while you use Icatibant, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Icatibant:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; nausea; pain, bruising, burning, warmth, swelling, numbness, or redness at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; severe or persistent burning, pain, swelling, or other irritation at the injection site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Icatibant side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include itching; redness; symptoms of low blood pressure (eg, fainting, light-headedness, severe or persistent dizziness).

Store Icatibant in the refrigerator or at room temperature, between 36 and 77 degrees F (2 and 25 degrees C). Store in the original container until you are ready to use it. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Icatibant out of the reach of children and away from pets.

General information:

• If you have any questions about Icatibant, please talk with your doctor, pharmacist, or other health care provider.
• Icatibant is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Icatibant. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.