Ilaris (canakinumab) is a biologic medicine that works by attaching to and blocking interleukin-1 beta (IL-1β), a type of cytokine found in the immune system that causes inflammation. The immune system is the body's natural defense system that protects against "foreign" invaders. By attaching to IL-1β, Ilaris helps to block its interaction with IL-1R and stops the immune system from triggering inflammation.

It is used to treat rare but serious autoimmune diseases that lead to inflammation, pain and swelling.

Ilaris (canakinumab) is a prescription medicine approved by the FDA for the following uses:

For the treatment of Periodic Fever Syndromes, such as:

1. Cryopyrin-Associated Periodic Syndromes (CAPS) in patients 4 years of age and older, including:

   • Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS)
   • Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adults and children
   • Hyperimmunoglobulin D Syndrome (HIDS) also known as Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients.
   • Familial Mediterranean Fever (FMF) in adult and pediatric patients. https://www.drugs.com/mcd/familial-mediterranean-fever

2. 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 injected by your healthcare provider just below the skin (subcutaneous) every 8 weeks for CAPS and every 4 weeks for TRAPS, HIDS/MKD, FMF, AOSD, and SJIA. However, if you qualify, you may be able to receive the injections at home by a home health nurse. Ask your healthcare provider about this option.

Your doctor will determine the best dose for you based on why you need this treatment and your weight.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

This medicine may raise your chances for very bad or even deadly health problems. Your doctor will monitor you for serious side effects. Ilaris can:

• Increase your risk of serious infections or cancer because it lowers the ability of your immune system to fight infections or ward off cancer. Tell your doctor if you have an infection or a history of infections that keep coming back.
• Your doctor should test you for tuberculosis (TB) before treatment with Ilaris and monitor you for symptoms of TB during treatment.
• Lead to a serious allergic reaction. You should not use Ilaris if you are allergic to canakinumab or any of the ingredients in the injection.
• Increase the risk of infection with live vaccines. Do not get live vaccines if you are receiving Ilaris. Talk to your doctor about any vaccines you may need before you start treatment with Ilaris.

Studies have not determined 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.

Like all medicines, Ilaris may be associated with side effects. Not everyone will experience all of these side effects. Depending upon why you are using this medicine, you may have risk for different side effects from other people.

• In those being treated for Cryopyrin-Associated Periodic Syndromes (CAPS), the most common side effects are: nasopharyngitis (common cold symptoms), diarrhea, influenza, runny nose, nausea, headache, bronchitis, gastroenteritis (viral stomach infection), pharyngitis (sore throat), increase in weight, muscle / joint pain, and vertigo (spinning type of dizziness).
• In people being treated for TRAPS, HIDS/MKD, and FMF, the most common side effects are injection-site reactions and nasopharyngitis (common cold symptoms).
• In people being treated for Still’s disease, the most common side effects are infections (nasopharyngitis and upper respiratory tract infections), abdominal (stomach area) pain, and injection-site reactions.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

Before you are treated with Ilaris, tell your doctor about all your medical conditions and any medicines you take. Tell them about your prescription drugs, over-the-counter medicines, vitamins, and herbal or dietary supplements you take.

Call your doctor for instructions right away if you miss an appointment for your Ilaris injection. Do not start, stop, or change the dose of Ilaris or any other medicine you take without first checking with your doctor.

Avoid being near people who are sick or have infections while taking Ilaris.

Let your healthcare provider know if you:

• Have an active infection, infections that keep coming back or symptoms of an infection. These symptoms may include 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.
• Have a history of low white blood cells (usually seen on a blood test).
• Have or have had HIV, hepatitis B, or hepatitis C viral infections.
• Are scheduled to receive any vaccines. You should not get ‘live vaccines’ if you are receiving Ilaris. Examples of live vaccine are chickenpox vaccine and the measles, mumps, and rubella (MMR) vaccine.
• Treatment with Ilaris may increase your risk of developing cancer. Talk to your doctor about your individual risk when using 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 this medicine.
• Received canakinumab (Ilaris) while you were pregnant. Also tell your baby’s doctor (pediatrician) if you received canakinumab when pregnant. Your baby's vaccination schedule may need to be adjusted in the first year of life.
• Are breastfeeding or plan on breastfeeding. It is not known if Ilaris passes into your breast milk. Ask your healthcare provider about the best way to feed your baby if you receive this medicine.

Response to Ilaris is often measured by laboratory tests and a doctor's evaluation of the patients' disease and symptoms.

Ilaris works quickly in most patients, but this can vary based on your health condition. Ask your doctor how quickly this treatment might work for you specifically.

For example, in studies Ilaris was shown to work quickly in most studies within one to two weeks.

• In Cryopyrin-Associated Periodic Syndromes (CAPS), most people (71%) experienced a complete response to treatment in just 7 days. Almost all patients (97%) experienced improvement in their CAPS symptoms (rash, fatigue, muscle pain, headache or migraine, sore or red eyes, and joint pain) within 8 weeks.
• In studies looking at Systemic Juvenile Idiopathic Arthritis (SJIA) in 190 patients, about 8 out of 10 children (80%) taking Ilaris had improvement in active SJIA symptoms, such as fever and swollen or painful joints. None of the children taking Ilaris had fever on the third day after their first dose. Approval of Ilaris for Adult-Onset Still's Disease (AOSD) was based on clinical effectiveness data from SJIA patients.
• For Familial Mediterranean Fever (FMF) in 31 patients, 61% of patients had minimal to no disease activity (chest pain, abdominal pain, painful and/or swollen joints, and skin rash) by Day 15 through 16 weeks.
• In 37 patients with Hyperimmunoglobulin D Syndrome (HIDS) / Mevalonate Kinase Deficiency (MKD), 35% had minimal to no disease activity (swollen lymph nodes, canker sores, and abdominal [stomach area] pain) by Day 15 through 16 weeks.
• For 22 patients with Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Ilaris led to minimal to no disease activity at day 15 through week 16 in about 46% of these patients. Improvements were seen in skin rash, muscle and joint pain, abdominal (stomach area) pain, and eye problems.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal or other dietary supplements.

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 affect enzyme metabolism

Ask your doctor or pharmacist if you take any of these types of medicines if you are not sure.

This is not a complete list of all drugs or health problems that interact with this drug. Always check with your doctor or pharmacist to be sure any medicine you take is safe to use with Ilaris.