What is the most important information I should know about icatibant?
You should not use icatibant if you are allergic to it.
To make sure you can safely use icatibant, 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 3 icatibant injections within a 24-hour period. Call your doctor if your symptoms do not improve, or if they get worse after using this medication.
What is icatibant?
Icatibant is used to treat attacks of hereditary angioedema (an immune system disorder). This medication is used in people who are at least 18 years old.
Icatibant is not a cure for hereditary angioedema.
Icatibant may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before receiving icatibant?
You should not use icatibant if you are allergic to it.
To make sure you can safely use icatibant, tell your doctor about all of your medical conditions.
FDA pregnancy category C. It is not known whether icatibant will harm an unborn baby. Tell your doctor if you are pregnant before using this medication.
It is not known whether icatibant passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How is icatibant given?
Icatibant is injected under the skin. You will be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Get emergency medical help if you have any swelling of your tongue or throat during an angioedema attack.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it looks cloudy or has particles in it. Call your doctor for a new prescription.
Wash your hands with soap and water before preparing your injection.
Do not give an injection into an area that is painful, swollen, or bruised.
If you still have symptoms of angioedema after the first injection, you may use another injection after at least 6 hours have passed.
Do not use more than 3 icatibant injections within a 24-hour period.
Call your doctor if your symptoms do not improve, or if they get worse after using this medication.
Each prefilled syringe of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Use a syringe and needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Store icatibant in the original container at room temperature, away from moisture and heat.
You may also store this medicine in the refrigerator. Do not freeze.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
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.
What should I avoid after receiving icatibant?
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
What are the possible side effects of icatibant?
Get emergency medical help if you have any of these signs of an allergic reaction after using icatibant:
- chest pain or discomfort, fast or weak heartbeat;
- flushing (warmth, redness, or tingly feeling);
- feeling like you might pass out;
- itching, rash, or hives;
- runny nose, sneezing, stuffy nose;
- wheezing, cough, throat irritation, trouble breathing; or
- swelling of your face, lips, tongue, or throat.
An allergic reaction to icatibant can cause symptoms that are very similar to the signs of hereditary angioedema.
Less serious side effects may include:
- dizziness, drowsiness, tired feeling;
- nausea, vomiting, diarrhea;
- fever;
- headache;
- mild skin rash; or
- pain, pressure, swelling, bruising, burning, warmth, redness, numbness, tenderness, itching, rash, or other irritation where the injection was given.
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.
What other drugs will affect icatibant?
Tell your doctor about all other medicines you use, especially a heart or blood pressure medication such as:
- benazepril (Lotensin, Lotrel);
- captopril (Capoten, Capozide);
- enalapril (Vasotec, Vaseretic);
- fosinopril (Monopril);
- lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
- moexipril (Univasc, Uniretic);
- perindopril (Aceon);
- quinapril (Accupril, Accuretic);
- ramipril (Altace); or
- trandolapril (Mavik, Tarka).
This list is not complete and other drugs may interact with icatibant. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about icatibant.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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