Answers to Your Questions About CAPS and ILARIS

What are Cryopyrin-Associated Periodic Syndromes (CAPS)?

CAPS are a group of rare genetic diseases that includes Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). CAPS are rare and chronic diseases that are part of a larger group of diseases known as Periodic Fever Syndromes.

What causes CAPS?

CAPS are inherited conditions that are generally passed on from other family members. CAPS are caused by an inherited mutated gene, called the NLRP3 gene (or the CIAS1 gene). In some cases, however, the genetic mutation responsible for CAPS may occur spontaneously at birth.

How long will my child have CAPS?

There is no cure for CAPS, but with continuous treatment, children with CAPS may experience symptom improvement.

What are Periodic Fever Syndromes?

Periodic Fever Syndromes are a group of rare, autoinflammatory diseases that are characterized by symptoms including recurrent fevers, rash, pain, and joint inflammation. Periodic Fevers are typically inherited from other family members, but can occur on their own. Both children and adults can be affected by Periodic Fevers, though symptoms usually begin during childhood.

Are CAPS contagious?

CAPS are not contagious. They're a group of inherited diseases that can be passed down from other family members, though they can also occur on their own. Certain factors are thought to trigger CAPS flares, including exposure to cold, drops in temperature, stress, and exercise.

What is ILARIS?

ILARIS^® is a prescription medication that is FDA approved to treat CAPS, including FCAS and MWS, in patients 4 years and older. ILARIS works by attaching to and blocking interleukin-1 beta (IL-1β), a type of cytokine responsible for inflammation. ILARIS is given every 8 weeks as a subcutaneous injection right below the skin.

How can ILARIS help with CAPS?

ILARIS specifically addresses inflammation caused by IL-1β that can lead to CAPS symptoms such as rash, joint and/or muscle pain, and eye irritation. ILARIS can also decrease the risk of flares, or the worsening of CAPS symptoms. ILARIS is given by a doctor or nurse as an injection right below the skin. Talk to your doctor to find out if ILARIS may be a treatment option for you or your child.

How fast does ILARIS work?

Seven days after just 1 dose of ILARIS, the majority of patients (71%) experienced a complete response* to treatment. 97% of patients experienced improvement in their CAPS symptoms within the first treatment period (8 weeks).

*In a clinical study of 35 patients, 97% had a complete response within the first treatment period (8 weeks). The majority of patients (71%) experienced a complete response to treatment in 7 days.

Complete response was measured by laboratory results and a doctor's evaluation of the patient's skin disease and symptoms being minimal or better, including symptoms such as: rash, fatigue, muscle pain, headache or migraine, sore or red eyes, and joint pain.

Is ILARIS given intravenously?

ILARIS is not given as an intravenous infusion (infused inside a vein over a period of time). Instead, it is given as a subcutaneous (right under the skin) injection, or shot, every other month by a doctor or nurse. A home health nurse can be sent to your home to administer ILARIS to your child. If you are eligible, this service and other ILARIS support opportunities may be available for your child.

How often will my child receive ILARIS?

ILARIS is given as a subcutaneous injection (right under the skin) by a doctor or nurse once every 8 weeks—just 6 or 7 treatments in a year.

Is support available to help us pay for ILARIS?

We're committed to helping you get access to ILARIS. Our representatives work with you and your child's doctor to help you get started, including:

Contacting your insurance company
Verifying insurance benefits and investigation of coverage
Addressing coverage issues
Assisting with prior authorization and appeals, if needed
Providing co-pay* assistance for eligible patients with commercial insurance
Providing information about alternative assistance options for uninsured patients

*Limitations apply. Please contact ILARIS Companion at 866-972-8315 for more information.

Who can I speak to if I have more questions about ILARIS?

Talk to your child's pediatric rheumatologist or other healthcare professional. Your child's active CAPS treatment team can consist of many important members. Make sure that you find a doctor that you and your child are both comfortable with.

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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
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 you 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.

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.

APPROVED USE

ILARIS^® (canakinumab) is a prescription medicine injected by your healthcare provider just below the skin (subcutaneous) used to treat adults and children aged 4 years and older who have auto-inflammatory diseases called Cryopyrin-Associated Periodic Syndromes (CAPS), including:

Familial Cold Autoinflammatory Syndrome (FCAS)
Muckle-Wells Syndrome (MWS)

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

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Answers to Your Questions About CAPS and ILARIS

Answers to Your Questions About CAPS and ILARIS

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