When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to canakinumab.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how canakinumab works. Tell your doctor if you are taking any of the following:
  
  • Adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, or rilonacept
  • A blood thinner (such as warfarin), or medicine that weakens your immune system, such as cancer medicines or steroids (hydrocortisone, methylprednisolone, prednisolone, prednisone)
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have an immune system problem, an infection, HIV or AIDS, hepatitis B, hepatitis C, tuberculosis (TB) or a history of TB, or have been in close contact with someone who has active TB.
• You may get infections more easily while you are taking this medicine.
• This medicine may increase your risk for cancer. Talk to your doctor if you have concerns about this risk.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, sore throat, and body aches
• Trouble swallowing

If you notice these less serious side effects, talk with your doctor:

• Dizziness, or the feeling of spinning or constant movement
• Headache
• Nausea or diarrhea
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given
• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088