Ilaris (canakinumab) reduces the effects of a substance in the body that can cause inflammation.
Ilaris is used to treat rare genetic conditions such as Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children who are at least 4 years old.
Ilaris may also be used for purposes not listed in this medication guide.
Important information
Ilaris can lower blood cells that help your body fight infections. Serious and sometimes fatal infections may occur during treatment with Ilaris. Call your doctor right away if you have signs of infection such as: flu symptoms, cough, shortness of breath, weight loss, redness or swelling under your skin, or fever lasting 3 days or longer.
Before receiving Ilaris
You should not use Ilaris if you are allergic to canakinumab.
Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
Make sure you are current on all vaccines before you begin treatment with Ilaris.
To make sure Ilaris is safe for you, tell your doctor if you have:
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an active infection;
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a history of low white blood cell counts;
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a weak immune system;
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a history of HIV, hepatitis B, or hepatitis C;
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a history of recurrent infections; or
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if you are scheduled to receive any vaccine.
FDA pregnancy category C. It is not known whether Ilaris will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether canakinumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Treatment with Ilaris may increase your risk of developing cancer. Talk to your doctor about your individual risk.
How should I use Ilaris?
Use Ilaris exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Before you start treatment with Ilaris, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Ilaris is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. Ilaris is usually given once every 8 weeks. Follow your doctor"s instructions.
You may be shown how to inject your medicine 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.
You will need to mix Ilaris with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.
Do not shake the medication vial (bottle) after mixing. Vigorous shaking can ruin the medicine. Do not draw your Ilaris dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.
After mixing your medicine, protect it from light and use it within 1 hour.
Each single-use vial (bottle) of Ilaris is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.
Use each disposable needle only one time. 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.
Ilaris can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.
Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.
Store the powder medicine in the refrigerator and do not freeze. Keep the Ilaris vial in its original carton to protect the medicine from light. Mixed medication may be stored in a refrigerator and used within 4 hours.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose of this medicine.
What happens if I overdose?
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid?
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while using Ilaris. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Ilaris side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Ilaris: hives; dizziness, nausea; fast or pounding heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.
Ilaris can lower blood cells that help your body fight infections. Serious and sometimes fatal infections may occur during treatment with Ilaris. Call your doctor right away if you have signs of infection such as:
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fever for 3 days or longer;
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cough, shortness of breath;
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warmth, redness, or swelling under your skin; or
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flu symptoms, weight loss.
Call your doctor at once if you have a side effect such as:
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swollen gums, painful mouth sores, pain when swallowing;
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skin sores; or
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pain, swelling, redness, warmth, blistering, or bleeding where an injection was given.
Common Ilaris side effects may include:
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itching, bruising, or minor irritation where the injection was given.
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nausea, diarrhea;
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headache, dizziness, spinning sensation; or
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runny or stuffy nose, sinus pain.
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.
See also: Side effects (in more detail)
What other drugs will affect Ilaris?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Ilaris, especially:
This list is not complete. Other drugs may interact with Ilaris, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
