What is TRAPS?

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WHAT IS
TRAPS?

Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) is a rare, chronic disease that's part of a group of diseases known as Periodic Fever Syndromes. TRAPS is an inherited disease that usually develops in people younger than 20 years of age, and it occurs in people from all ethnic backgrounds.

TRAPS is an autoinflammatory disease, meaning that it affects the body's immune system. This causes the immune system to work improperly, which can lead to TRAPS symptoms including fever, rash, stomach pain, painful joints and/or muscles, and eye irritations.

Autoinflammatory ≠ Autoimmune

Although their symptoms can be similar, and both trigger a reaction from your immune system, autoinflammatory diseases are not the same as autoimmune diseases. Your immune system is the body's natural defense against "foreign" invaders. But you have two immune systems in your body: innate and adaptive. Your innate immune system is the one you were born with, while your adaptive immune system is the one you develop over time, based on your life.

With an autoinflammatory disease, symptoms occur due to problems in the innate immune system, whereas autoimmune disease symptoms come from the adaptive immune system.

With TRAPS, the immune system triggers inflammation even when there's no infection to fight.

What causes TRAPS?

It's important to know TRAPS is not contagious. In fact, TRAPS is a genetic disease that is caused by a mutation of the TNFRSF1A (Tumor Necrosis Factor Receptor Super Family 1A) gene. When this happens, it can lead to inflammation and other TRAPS symptoms.

TRAPS is very rare, with an estimated prevalence of about 1 in every 1 million people worldwide.

If you or your child is diagnosed with TRAPS, talk to a doctor about ILARIS®, the only biologic medicine that is FDA approved to treat TRAPS.

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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

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.

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.

  • 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

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

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 auto-inflammatory 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-10881-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.

ILARIS is a registered trademark of Novartis AG.

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.

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.