Important Safety Information

You should not take ILARIS if you are allergic to canakinumab or any of the ingredients in ILARIS. ILARIS may affect your immune system and may lower your ability to fight infections. Infections, mostly of the upper respiratory tract, in some cases serious, have been reported with ILARIS treatment. Do not take ILARIS if you have an infection.

Before using ILARIS,

tell your healthcare provider if any of the following applies to you:

• If you think you have an infection or if you have infections that keep coming back or a condition which makes you susceptible to infections, such as an immune system problem.
• If you are being treated for an infection.
• If you have signs of an infection, such as fever, cough, or flu-like symptoms.
• If you require vaccinations; you should not be given "live vaccines" if you take ILARIS.
• If you have or have had HIV, Hepatitis B, or Hepatitis C.
• If you have tuberculosis (TB), or if you have been in close contact with someone who has or has had tuberculosis.
• If you are pregnant or planning to become pregnant; it is not known if ILARIS will harm your unborn child. Breast-feeding is not recommended during ILARIS therapy.
• If you are taking any prescription and/or non-prescription medications.

Especially tell your doctor if you take:

• Medicines that affect your immune system.
• IL-1 blocking agents such as Kineret^® (anakinra) or Arcalyst^® (rilonacept).
• Tumor Necrosis Factor (TNF) inhibitors such as Enbrel^® (etanercept), Humira^® (adalimumab), or Remicade^® (infliximab).

During treatment with ILARIS,

tell your doctor immediately or get emergency help if you have any of the following symptoms:

• Signs of infection such as fever lasting longer than 3 days, cough, redness at the injection site or another area of your body, or warmth or swelling of your skin.
• Signs of an allergic reaction such as rash, swollen face, or problems breathing or swallowing.

It is not known if treatment with ILARIS can lead to cancer or increase the risk of getting cancer.

Potentially serious side effects of ILARIS therapy include infection, allergic reactions, and a spinning sensation (vertigo). The most common side effects of ILARIS are cold or flu-like symptoms, nausea, diarrhea, headache, redness, swelling, warmth, or itching at the injection site, and a spinning sensation (vertigo). If you have any of these side effects, contact your doctor.

A very small number of patients in the clinical trials experienced a reaction at the injection site. If you have a reaction at the injection site that does not go away contact your doctor.