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Pronunciation: i.LAHR-us 

Generic name: canakinumab [KAN-a-KINue-mab] Pronunciation: canakinumab [KAN-aKIN-ue]
Dosage form: subcutaneous injection
Drug class: interleukin inhibitors

What is Ilaris?

Ilaris is a medication used to treat various kinds of periodic fever

syndromes, including Still's disease and gout flares. Ilaris is a drug that blocks substances in the body that may cause inflammation as well as other immune reactions. Ilaris is an antigen monoclonal that is part of a class of drugs known as interleukin-1 beta (IL-1b) blockers.

Ilaris (canakinumab) Ilaris (canakinumab) is administered in the form of an injection under the skin (subcutaneous injection) four times a week, eight weeks or 12 weeks, based on the condition being treated.

Ilaris was approved by the FDA on June 18th, 2009, initially for treating cryopyrin-associated periodic syndrome (CAPS). Since then, more indications have been accepted. On August 25, 2023, Ilaris was approved to treat gout flares in a specific adult population.

What is Ilaris?

Ilaris is FDA-approved for treating:

Periodic fever syndromes

  • Cryopyrin-Associated Perioperative Syndromes (CAPS), comprising Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), for patients aged 4 and older

  • Tumour Necrosis Factor Receptor Associated with Periodic Disorder (TRAPS) in children and adults

  • Hyperimmunoglobulin-D Syndrome (HIDS), sometimes referred to as Mevalonate Kinase Deficiency (MKD) in paediatric and adult patients

  • Family Mediterranean Fever (FMF) affects patients of both ages, paediatric and adult.

Active Still's Disease

  • In addition, it includes Adult-Onset Still's Disorder (AOSD) along with Systemic Juvenile Idiopathic Arthritis (SJIA) for patients who are 2 years old or older.

Gout flares

  • For adults for whom non-steroidal anti-inflammatory medicines (NSAIDs) or colchicine are not appropriate, are not a good choice, or don't provide adequate relief, and when repeated doses of corticosteroids aren't appropriate.

The periodic fever syndrome is a rare and usually inherited disorder due to mutations in specific genes, which are usually those involved in the creation of an enzyme or protein within the body. Patients suffering from periodic fever syndrome experience instances of fever and inflammation without any other cause like an infection or virus.

It is an auto-inflammatory disorder that could be caused by having too much or being insensitive to certain proteins, like interleukin-1 beta (IL-1b), which can cause symptoms like headache, fever, rash, feeling exhausted (fatigue), or painful joints or muscles.

Gout is a condition that can be acute. (gout flare) occurs due to the accumulation of urate within your body and creates needle-shaped crystals around and in the joint. These crystals can cause inflammation and an overproduction of certain proteins, including interleukin-1 beta (also known as IL-1b), and may cause extreme pain that is sudden and intense or redness, heat, and swelling of joints.

Side effects of Ilaris 

The most frequent adverse effects are:

  • The symptoms of a cold or flu (runny nose, cough, sore throat, and body pains);

  • Nausea, vomiting, diarrhea, and  stomach pain;

  • Urination that is painful

  • Dizziness, spinning sensation;

  • Headache;

  • Weight gain 

  • Itching, redness, swelling, or warmth in the area where the medicine was injected.

Serious Ilaris side effects

Seek medical attention immediately. If you notice symptoms of an allergic reaction, Ilaris: hives; nausea; difficulty eating; dizziness; quick or rapid heartbeats; difficulty breathing; swelling of your lips, face, and throat.

Infections that are fatal and often deadly can occur when you are treated with Ilaris. Contact your doctor immediately if you are showing symptoms of infection, such as:

  • The fever lasts for more than 3 days. fever lasting more than 3 days, chills, sweating

  • Heat, sores, or pain in your body;

  • Stomach pain, diarrhoea, weight loss;

  • Continuous cough, shortness of breath;

  • Chest pain; chest pain; coughing up mucus or blood;

  • Discomfort or burning sensation after you urinate;

  • The area of your body.

  • Warmth, redness, or swelling under your skin; or

  • Influenza symptoms include feeling extremely tired.

This isn't a complete list of possible side effects, and there are other possible side effects. Contact your doctor to seek medical advice on the effects. You can report any side effects to the FDA at 1-800-FDA-1088.


Sometimes fatal and serious infections can occur while taking Ilaris. Consult your physician right away if you are experiencing symptoms of infection, such as sweating, chills, fever, fatigue, coughing, or shortness of breath. skin ulcers, warm or painful areas of your body, vomiting or stomach discomfort, and losing weight.

Your physician must examine you for the presence of tuberculosis (TB) before you are given this medication and keep an eye on you closely for signs of TB while you are receiving treatment.

Macrophage activation syndrome (MAS) is one condition that is associated with Still's disease as well as other autoinflammatory diseases such as MKD and HIDS that could lead to death. Contact your doctor immediately if you notice that your symptoms of SJIA or AOSD get worse or are experiencing any of the following symptoms of infection:

  • A fever that lasts longer than 3 days

  • A cough that doesn't disappear

  • The body, It is red in one area of your body.

  • The sensation of warmth or swelling on your skin

Before you take this drug. 

It is not recommended to use Ilaris if you are allergic to canakinumab.

Consult your physician whether you've ever suffered from tuberculosis, if someone within your family is suffering from tuberculosis, or if you've recently been to an area where tuberculosis can be found.

To be sure Ilaris is suitable for you, inform your doctor if you've previously had:

  • An active or chronic illness;

  • Low white blood cell count;

  • An immune system that is weak;

  • HIV, Hepatitis B, or Hepatitis C;

  • A history of recurring infections or

  • If you recently received or are due to be given any vaccination,

Be sure to be current with all vaccines prior to starting the treatment process with Ilaris. It is not recommended to receive live vaccines when you are receiving treatment with this medication until your doctor tells you that your immune system isn't compromised.

The treatment with Ilaris can increase the chances of getting cancer. Consult your physician about the risk you face.


Inform your doctor if you are expecting or planning to be pregnant. It isn't known whether Ilaris could affect your baby's unborn child. Contact your healthcare professional immediately if you become pregnant while taking this medication.

If you're using Ilaris when you're pregnant, be sure that the doctor taking care of your baby is aware that you took the medication during your pregnancy. Exposure to Ilaris while pregnant could alter your baby's vaccination schedule in the first year of their life.


It might not be safe to breastfeed while taking this medication. Discuss with your doctor any potential risks. Discuss with your healthcare provider the best method to feed your child if you get Ilaris.

How to take Ilaris?

Ilaris is administered as an injection beneath the skin (subcutaneous injection) by a healthcare professional.

Ilaris is generally given:

  • At least once every eight weeks to treat cryopyrin-associated periodic syndromes and

  • Each 4th week for TRAPS, MKD/HIDS, FMF, AOSD, and SJIA.

  • In a single dose when gout flares. If you experience an outbreak that is new and require an additional dose of Ilaris, it is recommended to be patient for at least 12 weeks prior to receiving another dose.

Before starting treatment with Ilaris Your doctor will run tests to confirm that you don't have tuberculosis or any other infections.

Consult your physician when you notice any weight changes. Canakinumab doses are determined by weight (especially in teenagers and children), and any change could affect the dosage.

Ilaris could reduce your immune system. Your blood might require frequent testing.

What Happens If I Miss a Dose?

Consult your physician for the proper procedure. If you do not make an appointment to receive an Ilaris injection,

What Happens If I Overdose?

Since the medication is prescribed by a medical expert in a medical environment, the risk of overdose is less likely to occur.

What should be avoided?

Beware of those who are sick or suffer from infections. Contact your doctor right away in the event that you show symptoms of an infection.

Don't receive any "live" vaccines while using Ilaris. The vaccine might not function in the same way at this point and could not fully safeguard you from illness. The live vaccines are measles, rubella, and mumps (MMR), as well as rotavirus, yellow fever, typhoid, varicella (chickenpox), zoster (shingles), and the nasal influenza (flu) vaccine.

Interaction with other drugs

There are times when it's not recommended to take certain medications simultaneously. Certain medications can alter the blood levels of other medications you are taking, which could cause more side effects or make the drugs less effective.

Inform your doctor about any other medications you take, particularly:

  • Agents that block IL-1, such as Anakinra, Rilonacept, and Rilonacept

  • Tumour Necrosis Factor (TNF) inhibitors, including adalimumab, etanercept, certolizumab, golimumab, and infliximab;

  • Etanercept, rilonacept;

  • Warfarin or

  • Medications that alter the metabolism of enzymes

  • Other medications that weaken the immune system, such as steroids, chemotherapy, and other medications that help prevent rejection of organ transplants.

This list isn't comprehensive. Other drugs can interact with canakinumab. These include prescription and non-prescription medications, vitamins, and herbal supplements. Some interactions with drugs are not listed here. are included here.