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IMPORTANT SAFETY INFORMATION

ILARIS can cause serious side effects, including increased risk of serious infections. ILARIS can lower the ability of your immune system to fight infections. Your healthcare provider should:

• test you for tuberculosis (TB) before you receive ILARIS

• monitor you closely for symptoms of TB during treatment with ILARIS

• check you for symptoms of any type of infection before, during, and after treatment with ILARIS

Tell your healthcare provider right away if you have any symptoms of an infection such as fever, sweats or chills, cough, flu-like symptoms, weight loss, shortness of breath, blood in your phlegm, sores on your body, warm or painful areas on your body, diarrhea or stomach pain, or feeling very tired.

You should not receive ILARIS if you are allergic to canakinumab or any of the ingredients in ILARIS.

Before receiving ILARIS, tell your healthcare provider about all your medical conditions, including if you:

• think you have or are being treated for an active infection

• have symptoms of infection

• have a history of infections that keep coming back

• have a history of low white blood cells

• have or have had HIV, Hepatitis B, or Hepatitis C

• are scheduled to receive any immunizations (vaccines). You should not get 'live vaccines' if you are receiving ILARIS.

• are pregnant or planning to become pregnant. It is not known if ILARIS will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving ILARIS.

• are breastfeeding or planning to breastfeed. It is not known if ILARIS passes into your breast milk. You and your healthcare provider should decide if you will receive ILARIS or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

• medicines that affect the immune system

• medicines called interleukin-1 (IL-1) blocking agents such as Kineret^® (anakinra) or Arcalyst^® (rilonacept)

• medicines called Tumor Necrosis Factor (TNF) inhibitors such as Enbrel^® (etanercept), Humira^® (adalimumab), Remicade^® (infliximab), Simponi^® (golimumab), or Cimzia^® (certolizumab pegol)

• medicines that affect enzyme metabolism.

Ask your healthcare provider if you are not sure.

ILARIS can cause serious side effects including:

• serious infections

• decreased ability of the body to fight infections (immunosuppression). For people treated with medicines that cause immunosuppression like ILARIS, the chances of getting cancer may increase.

• allergic reactions. Allergic reactions can happen while receiving ILARIS. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction: rash, itching and hives, difficulty breathing or swallowing, dizziness, or feeling faint.

• risk of infection with live vaccines. You should not get live vaccines if you are receiving ILARIS. Tell your healthcare provider if you are scheduled to receive any vaccines.

The most common side effects of ILARIS when used for the treatment of CAPS include: cold symptoms, diarrhea, flu (influenza), runny nose, headache, cough, body aches, nausea, vomiting, and diarrhea (gastroenteritis), feeling like you are spinning (vertigo), weight gain, injection site reactions (such as redness, swelling, warmth, or itching), and nausea.

The most common side effects of ILARIS when used for the treatment of TRAPS, HIDS/MKD, and FMF: cold symptoms, upper respiratory tract infection, runny nose, sore throat, nausea, vomiting, and diarrhea (gastroenteritis), and injection site reactions (such as redness, swelling, warmth, or itching)

The most common side effects of ILARIS when used for the treatment of SJIA include: cold symptoms, upper respiratory tract infection, pneumonia, runny nose, sore throat, urinary tract infection, nausea, vomiting and diarrhea (gastroenteritis), stomach pain, and injection site reactions (such as redness, swelling, warmth, or itching)

Tell your healthcare provider about any side effect that bothers you or does not go away.

What is Macrophage Activation Syndrome (MAS)?

MAS is a syndrome associated with SJIA and some other auto-inflammatory diseases like HIDS/MKD that can lead to death. Tell your healthcare provider right away if your SJIA symptoms get worse or if you have any of these symptoms of an infection:

• a fever lasting longer than 3 days

• a cough that does not go away

• redness in one part of your body

• warm feeling or swelling of your skin

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.

INDICATIONS

ILARIS^® (canakinumab) is a prescription medicine injected by your healthcare provider just below the skin (subcutaneous) used to treat:

• The following Periodic Fever Syndromes

  • Cryopyrin-Associated Periodic Syndromes (CAPS) in patients 4 years of age and older, including:

    • Familial Cold Autoinflammatory Syndrome (FCAS)

    • Muckle-Wells Syndrome (MWS)

  • Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients

  • Hyperimmunoglobulin D Syndrome (HIDS) also known as Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients

  • Familial Mediterranean Fever (FMF) in adult and pediatric patients

• Systemic Juvenile Idiopathic Arthritis (SJIA) in children 2 years of age and older.

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