Answers to Your Questions About SJIA and ILARIS

What is SJIA?

SJIA is an autoinflammatory disorder which can be caused by having too much of or being too sensitive to certain proteins, including IL-1β, and can lead to symptoms such as fever, rash, headache, feeling very tired (fatigue), or painful joints and muscles. SJIA is a type of Still's disease.

What causes SJIA?

SJIA is an idiopathic disease, which means that its cause is unknown. What is known about SJIA is that it's an autoinflammatory disease, meaning that it causes the body's immune system to attack healthy cells, leading to the signs and symptoms of SJIA.

How long will my child have SJIA?

It can vary. Your child may need to undergo SJIA treatment for a period of several years or more. But with treatment, children with SJIA can experience symptom improvement as time passes.

What is the difference between a localized and a systemic symptom?

Instead of localized symptoms, such as pain in certain joints, systemic symptoms can affect the body as a whole. For example, a systemic symptom of SJIA is fever.

What will happen to my child with SJIA?

SJIA affects every child differently. The disease cycle swings back and forth between symptom-free periods and flares, or times when the symptoms worsen. Some children with SJIA only get one cycle of symptoms, and others will have a chronic course of ups and downs. Learn about SJIA treatment options.

What is ILARIS?

ILARIS^® is a prescription medication that is FDA approved to treat Still's disease, including SJIA in patients 2 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 once a month as a subcutaneous injection right below the skin.

How can ILARIS help with active SJIA?

Once-monthly ILARIS can help relieve SJIA symptoms, including fevers (systemic) and painful and/or swollen joints (arthritic). In addition, some children receiving ILARIS were able to reduce or stop taking corticosteroids altogether. This finding was observed in a clinical trial in which 92 of 128 patients taking corticosteroids at the study entry had entered the part of the clinical trial to see if they could reduce or stop taking corticosteroids. ILARIS is given by a doctor or nurse as a once-monthly injection right below the skin. Talk to your doctor to find out if ILARIS may be a treatment option for your child.

How fast does ILARIS work?

190 children were entered into a clinical study to determine the impact of ILARIS on SJIA symptoms. Fifteen days after their first dose of ILARIS, approximately 8 out of 10 children taking ILARIS experienced improvement in active SJIA symptoms, such as fever and painful and/or swollen joints. None of the children taking ILARIS had fever by day 3 after the first dose.

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, once a month by a doctor or nurse.

How often will my child receive ILARIS?

ILARIS is given as a once-monthly injection. 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.

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 SJIA 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 vaccincations 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 your 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 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-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 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.

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Answers to Your Questions About SJIA and ILARIS

Answers to Your Questions About SJIA and ILARIS

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