Canakinumab, Injection

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KEY POINTS

• This medicine is given by injection to treat juvenile idiopathic arthritis and Cryopyrin-associated periodic syndromes.
• You may get serious infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: interleukin-1 beta blocker

Generic and brand names: canakinumab, injection; Ilaris

What is this medicine used for?

This medicine is given by injection to treat:

• Juvenile idiopathic arthritis (JIA)
• Cryopyrin-associated periodic syndromes (CAPS)

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Hepatitis B or hepatitis C
• HIV/AIDS
• Low white blood cell counts
• Tuberculosis (TB) or have recently been exposed to TB

Tell your healthcare provider if you have an infection or have infections that keep coming back. Also, tell your healthcare provider if you have recently had a vaccination or are scheduled to receive any kind of vaccination. It is best to have vaccines up to date before you start treatment with this medicine.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you have a treatment.

These injections are given by your healthcare provider. You will be monitored closely for side effects. Keep all appointments.

What should I watch out for?

If you are being treated for JIA, tell your healthcare provider right away if your symptoms get worse, or if you have:

• A fever lasting longer than 3 days
• A cough that does not go away
• Redness in one part of the body
• Warm feeling or swelling of the skin

You may get serious infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

You need to have exams and blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fever, cough, or sore throat that does not go away; breathing problems; unexplained weight loss; severe dizziness or fainting; unusual tiredness or weakness; unexplained swelling or redness; any skin rash or sores; severe stomach pain or diarrhea; painful urination; blood in urine.

Other: Runny or stuffy nose, headache, mild stomach pain or diarrhea, nausea, weight gain; pain, redness, itching, or swelling at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking any other medicines.

• Cancer medicines
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Denosumab (Prolia)
• Echinacea
• Fingolimod (Gilenya)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), pimecrolimus (Elidel), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), anakinra (Kineret), leflunomide (Arava), rituximab (Rituxan), tocilizumab (Actemra), and tofacitinib (Xeljanz)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), belimumab (Benlysta), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), and infliximab (Remicade)
• Natalizumab (Tysabri)
• Rilonacept (Arcalyst)
• Roflumilast (Daliresp)
• Vaccines
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.