ILARIS Safety Considerations

Before you receive 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 an 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

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 your treatment with ILARIS

  • 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 you are 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

Safety Considerations SJIA

ILARIS was specifically studied and FDA approved for kids 2 years of age and older with active Systemic Juvenile Idiopathic Arthritis (SJIA).

During SJIA studies:

  • ILARIS wasn't shown to affect the risk of developing macrophage activation syndrome (MAS), but no conclusion can be made

  • No children stopped treatment with ILARIS due to injection-site reactions

    • Up to 14% had injection-site reactions: most were mild

Next: Dosing and How ILARIS Works