What You Should Know About ILARIS^®

ILARIS^® Is a Prescription Treatment

You should know that ILARIS^® (canakinumab) is available by prescription only. This means you will have to talk to a doctor in order to get ILARIS^®.

ILARIS^® is a medicine that is used to treat adults and children aged 4 years and older that have FCAS (Familial Cold Autoinflammatory Syndrome) or Muckle-Wells Syndrome (MWS), 2 conditions in a group of rare diseases called CAPS (Cryopyrin-Associated Periodic Syndrome).

Another thing you should know is that ILARIS^® is given as an injection by a doctor only once every 8 weeks—just 6 or 7 treatments in a year.

• The ILARIS^® injection may be given by your doctor in office
• Your doctor may also arrange to have the ILARIS^® injection given in your home by a visiting nurse

Only a physician can determine whether you or your loved one has CAPS, so be sure to discuss all symptoms with your doctor. If you are diagnosed with CAPS, ILARIS^® may provide you with a Complete and Long-Lasting Response

• 97% of CAPS patients had complete response within the first treatment period (8 weeks). The majority of patients (71%) had complete response in just 7 days
• Complete response was measured by lab results and by the doctor's evaluation of the patient's skin disease and symptoms as being minimal or better, including symptoms such as rash, fatigue, muscle pain, headache or migraine, sore or red eyes, and joint pain
• A flare was measured by lab results and by the doctor's evaluation of the patient's symptoms as being mild or worse, or an evaluation of both the patient's symptoms and skin disease as being minimal or worse
• Download the Talking to Your Doctor Discussion Guide for a few simple suggestions to start a conversation with your doctor about CAPS

Click here to learn more about CAPS in the section Facts About CAPS

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.