PROVEN RESULTS
WITH
ILARIS
FOR HIDS/MKD

ILARIS® is the first and only injection that is FDA approved to treat Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency (HIDS/MKD), by once-monthly administration. The FDA approval was based on research that included 181 children and adults with Periodic Fever Syndromes.

ILARIS helped provide symptom relief

In a clinical study, patients with HIDS/MKD were given ILARIS and evaluated for a complete response. A complete response means that at Day 15 and throughout the entire 16-week treatment period, there is minimal or no disease activity.

Study participants were assessed for their CRP* measurements and given a Physician's Global Assessment (PGA) score. The PGA is a 5-point scale used to evaluate the overall disease severity of a patient.

*CRP: C-reactive protein is a blood test to measure inflammation in the body.

Each patient's PGA score was based on several signs and symptoms, including:

Abdominal Pain

Abdominal and/or Stomach Pain

Canker Sores

Canker Sores

Swollen Lymph Nodes

Swollen Lymph Nodes

The following percentage of
people with HIDS/MKD
achieved a complete response.

35.1% of HIDS/MKD patients had minimal or no disease activity just 15 days after their first dose of ILARIS

35.1% of HIDS/MKD patients
had
minimal or no disease
activity at
Day 15 through
Week 16 of the
study.

(n=13/37)

Talk to a doctor about whether
ILARIS
may be right for you or
your child.

Next: Safety Considerations arrow

11/23   307076

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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.

Do 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

  • have recently received or are scheduled to receive any vaccinations

    • You should be brought up to date with all age required vaccines before starting treatment with ILARIS

    • You should not receive "live" vaccines while you are being treated with ILARIS and until your healthcare provider tells you that your immune system is no longer weakened

APPROVED USE

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

  • The following autoinflammatory 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

  • Still's disease including Adult-Onset Still's Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in children 2 years of age and older

  • Gout flares in adults who:

    • are not able to receive or tolerate treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine

    • have not responded to treatment with NSAIDs and colchicine

    • are not able to receive repeated treatment with steroids

It is not known if ILARIS is safe and effective when used to treat:

  • SJIA in children under 2 years of age

  • CAPS in children under 4 years of age

  • gout flares in children

  • 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

  • received ILARIS while you were pregnant. It is important that you tell your baby's healthcare provider before any vaccinations are given to your baby within 4 to 12 months after you received your last dose of ILARIS before giving birth

  • are breastfeeding or planning to breastfeed. It is not known if ILARIS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive ILARIS

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 your 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 for a list of these medicines 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: difficulty breathing or swallowing, nausea, dizziness or feeling faint, rash, itching or hives, palpitations (feels like your heart is racing), or low blood pressure

  • 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 include: 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 Still's disease (AOSD and 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).

The most common side effects of ILARIS when used for the treatment of gout flares include: cold symptoms, upper respiratory tract infection, urinary tract infection, increased levels of triglycerides in blood, and back pain.

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 Still's disease and some other autoinflammatory diseases like HIDS/MKD that can lead to death. Tell your healthcare provider right away if your AOSD or 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-1088.1-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.

All trademarks and registered trademarks are the property of their respective owners.

APPROVED USE

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

  • The following auto-inflammatory 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

  • Still's disease including Adult-Onset Still's Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in children 2 years of age and older.

  • Gout flares in adults who:

    • are not able to receive or tolerate treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine

    • have not responded to treatment with NSAIDs and colchicine

    • are not able to receive repeated treatment with steroids

It is not known if ILARIS is safe and effective when used to treat SJIA in children under 2 years of age or when used to treat CAPS in children under 4 years of age or when used to treat gout flares in children.