What is Ilaris (canakinumab), and how does it work?
Ilaris is a prescription medicine injected by your healthcare provider just below the skin (subcutaneous) used to treat:
- The following Periodic Fever Syndromes
- Adults and children 4 years of age and older who have auto-inflammatory diseases called Cryopyrin-Associated Periodic Syndromes (CAPS), including:
- Familial Cold Auto-inflammatory Syndrome (FCAS)
- Muckle-Wells Syndrome (MWS)
- Adults and children who have an auto-inflammatory disease called Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS)
- Adults and children who have an auto-inflammatory disease called Hyperimmunoglobulin D Syndrome (HIDS) (also known as Mevalonate Kinase Deficiency (MKD).
- Adults and children who have an auto-inflammatory disease called Familial Mediterranean Fever (FMF).
- Adults and children 4 years of age and older who have auto-inflammatory diseases called Cryopyrin-Associated Periodic Syndromes (CAPS), including:
- 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.
What are the side effects of 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.
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.
- 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
- rash
- nausea
- itching or hives
- dizziness or feeling faint
- palpitations (feels like your heart is racing)
- 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 include:
When Ilaris is used for the treatment of CAPS:
- 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)
- nausea
When Ilaris is 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)
- injection-site reactions (such as redness, swelling, warmth, or itching)
When Ilaris is used for the treatment of Still’s disease (AOSD and SJIA):
- cold symptoms
- upper respiratory tract infection
- pneumonia
- runny nose
- sore throat
- urinary tract infection
- nausea, vomiting, and diarrhea (gastroenteritis)
- stomach pain
- 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.
These are not all the possible side effects of Ilaris. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Ilaris?
- Ilaris is given by your healthcare provider every 8 weeks for CAPS and every 4 weeks for TRAPS, HIDS/MKD, FMF, AOSD, and SJIA.
What drugs interact with 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 your immune system
- medicines called IL-1 blocking agents such as Kineret (anakinra), 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 effect enzyme metabolism
Ask your healthcare provider for a list of these medicines if you are not sure.
Is Ilaris safe to take while pregnant or breastfeeding?
Tell your healthcare provider if you
- 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.