ILARIS® is the first once-monthly injection that is FDA approved for active Systemic Juvenile Idiopathic Arthritis (SJIA) in children 2 years of age and older. This FDA approval was based on research that included 190 children.
3 days after taking their first dose of ILARIS, 100% of children with SJIA had no fever
15 days after their first dose of ILARIS, approximately 8 out of 10 children experienced improvement in their SJIA symptoms (fever and painful and/or swollen joints)
Almost half (46%) of the children whose SJIA symptoms were controlled appropriately were able to stop taking corticosteroids completely after 5 months
Of the children whose SJIA symptoms were controlled, nearly two-thirds (62%) of those taking ILARIS were on a lower dose of corticosteroids after 5 months
*128 patients entered the clinical study taking corticosteroids. 92 of these patients entered a part of the clinical trial to see if they could reduce or stop taking corticosteroids.
Talk to a doctor about whether ILARIS may be right for your child.Next: Safety Considerations
IMPORTANT SAFETY INFORMATION
ILARIS can cause serious side effects, including increased risk of serious infections. ILARIS can lower the ability of your child's 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:
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: 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 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.
ILARIS® (canakinumab) is a prescription medicine injected by your healthcare provider just below the skin (subcutaneous) used to treat Systemic Juvenile Idiopathic Arthritis (SJIA) in children 2 years of age and older.
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