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What should I discuss with my health care provider before using canakinumab (Ilaris)?

You should not use this medication if you are allergic to canakinumab.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• an active infection;
• a history of recurrent infections;
• a weak immune system; or
• a history of tuberculosis.

FDA pregnancy category C. It is not known whether canakinumab is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether canakinumab 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.

Treatment with canakinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.

How should I use canakinumab (Ilaris)?

Use this medication 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 canakinumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Canakinumab is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. Canakinumab 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 canakinumab 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 canakinumab 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 this medicine 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.

Canakinumab 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 vial in its original carton to protect the medicine from light. Mixed medication may be stored in a refrigerator and used within 4 hours.

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