What is Ilaris?
Ilaris is used to treat certain types of periodic fever syndromes, Still’s Disease and gout flares. Ilaris works by blocking proteins in the body that can affect inflammation and other immune responses. Ilaris is a monoclonal antibody that is from a class of medicines called Interleukin-1 beta (IL-1β) blockers.
Ilaris (canakinumab) is given as an injection under the skin (subcutaneous injection) 4 weekly, 8 weekly or 12 weekly, depending on the condition being treated.
Ilaris became an FDA-approved medicine on June 18, 2009, originally to treat cryopyrin-associated periodic syndrome (CAPS), and since then more indications have been approved. On August 25, 2023, Ilaris becomes approved for gout flares in specific adults.
What is Ilaris used for?
Ilaris is FDA-approved to treat:
Periodic Fever Syndromes
- Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in patients 4 years and older.
- Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients
- Hyperimmunoglobulin D Syndrome (HIDS)/, also called Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients
- Familial Mediterranean Fever (FMF) in adult and pediatric patients
Active Still’s Disease
- Including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older
- for adults that non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.
Periodic fever syndromes are rare and often inherited conditions caused by mutations in certain genes, usually genes that are involved in producing a certain protein or enzyme in the body. People with periodic fever syndrome have episodes of fever and inflammation without other causes, such as infection or virus.
Still’s disease is an autoinflammatory disorder that can be caused by having too much or being too sensitive to certain proteins, including interleukin-1 beta (IL-1β), and can lead to symptoms such as fever, rash, headache, feeling very tired (fatigue), or painful joints and muscles.
Acute gout (gout flare) is caused when you have a build-up of urate in the body, which causes needle-shaped crystals to form in and around the joint. These crystals lead to inflammation with excessive production of specific proteins, such as interleukin-1 beta (also called IL-1β), which in turn can lead to sudden, severe pain, redness, warmth, and swelling in a joint.
Ilaris side effects
Common Ilaris side effects
The most common side effects include:
- cold or flu symptoms (runny nose, cough, sore throat, body aches);
- nausea, vomiting, diarrhea, stomach pain;
- painful urination;
- dizziness, spinning sensation;
- weight gain; or
- itching, redness, swelling, or warmth where the medicine was injected.
Serious Ilaris side effects
Get emergency medical help if you have signs of an allergic reaction to Ilaris: hives; nausea, trouble swallowing; dizziness, fast or pounding heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with Ilaris. Call your doctor right away if you have signs of infection such as:
- fever lasting longer than 3 days, chills, sweating;
- sores, warmth, or pain anywhere on your body;
- stomach pain, diarrhea, weight loss;
- ongoing cough, shortness of breath;
- chest pain, coughing up mucus or blood;
- pain or burning when you urinate;
- redness in one part of your body;
- warmth, redness, or swelling under your skin; or
- flu symptoms, feeling very tired.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Serious and sometimes fatal infections may occur during treatment with Ilaris. Call your doctor right away if you have signs of infection such as fever, chills, sweating, tiredness, cough, shortness of breath, skin sores, warm or painful areas on your body, diarrhea, stomach pain, or weight loss.
Your healthcare provider should test you for tuberculosis (TB) before you receive this medicine and monitor you closely for symptoms of TB during treatment.
Macrophage activation syndrome (MAS) is a syndrome associated with Still’s disease and some other autoinflammatory diseases like HIDS/MKD that can lead to death. Tell your healthcare provider right away if your AOSD or 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.
Before taking this medicine
You should not use Ilaris if you are allergic to canakinumab.
Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
To make sure Ilaris is safe for you, tell your doctor if you have ever had:
- an active or chronic infection;
- low white blood cell counts;
- a weak immune system;
- HIV, hepatitis B, or hepatitis C;
- a history of recurrent infections; or
- if you have recently received or are scheduled to receive any vaccine.
Make sure that you are current on all vaccines before you begin treatment with Ilaris. You should not receive ‘live’ vaccines while you are being treated with this medicine until your healthcare provider tells you that your immune system is no longer weakened.
Treatment with Ilaris may increase your risk of developing cancer. Talk to your doctor about your individual risk.
Tell your doctor if you are pregnant or plan 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.
If you use Ilaris while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to Ilaris in the womb could affect your baby's vaccination schedule during the first 12 months of life.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. Talk to your healthcare provider about the best way to feed your baby if you receive Ilaris.
How will I receive Ilaris?
Ilaris is given as an injection under the skin (subcutaneous injection) by a healthcare provider.
Ilaris is usually given:
- once every 8 weeks for Cryopyrin-Associated Periodic Syndromes and
- every 4 weeks for TRAPS, HIDS/MKD, FMF, AOSD, and SJIA
- as a single dose at the time of a gout flares. If you have a new flare and need another dose of Ilaris, you must wait at least 12 weeks before receiving the next dose.
Before you start treatment with Ilaris, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Tell your doctor if you have any changes in weight. Canakinumab doses are based on weight (especially in children and teenagers), and any changes may affect the dose.
Ilaris can weaken your immune system. Your blood may need to be tested often.
Click the link below for more detailed dosing information.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Ilaris injection.
What happens if I overdose?
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while using Ilaris?
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while using Ilaris. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
What other drugs will affect Ilaris?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Tell your doctor about all your other medicines, especially:
- IL-1 blocking agents including Anakinra, rilonacept;
- Tumor Necrosis Factor (TNF) inhibitors including adalimumab, etanercept certolizumab, golimumab, infliximab;
- etanercept, rilonacept;
- warfarin; or
- medicines that affect enzyme metabolism
- other drugs that weaken immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.
This list is not complete. Other drugs may interact wth canakinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Active ingredient: canakinumab.
Inactive ingredients: L-histidine, L-histidine HCl monohydrate, mannitol, polysorbate 80, sterile water for injection.
- Unopened vial stored at 2°C to 8°C (36°F to 46°F).
- Do not freeze.
- Store in the original carton to protect from light.
- Do not use beyond the date stamped on the label.
- This medicine does not contain preservatives.
- Discard any unused portions of this medicine or waste material in accordance with local requirements.
Manufactured by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey. 07936
Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936.
Yes, Ilaris can suppress the immune system, and it is considered an immunosuppressant. Ilaris works by binding to human interleukin 1beta and blocks its interaction with IL-1 receptors. Il-1 is an inflammatory cytokine and is one of the main regulators of inflammation, playing an important role in health and disease. Il-1 is mainly made by one type of white blood cell, called a macrophage, and it helps another type of white blood cell, the lymphocyte, fight infections. Ilaris reduces inflammation but because it weakens your immune system it can also make you more susceptible to infections and increase your risk of malignancies. You will need regular blood tests while you are taking Ilaris and you need to tell your doctor if you develop any sort of infection.
Your doctor will give you Ilaris (canakinumab) as a subcutaneous injection just below the skin. Ilaris is administered only by your healthcare provider either every 4 weeks or every 8 weeks depending upon your diagnosis.
Ilaris is an expensive medicine and costs about $17,700 for a one mL vial. It is given as an injection under the skin usually every 4 or 8 weeks. Your dose is based on your weight. Most people get help paying for their medicine from insurance or the manufacturer.
Ilaris works very quickly with most people (71%) experiencing a complete response to treatment in just 7 days. A few people take a bit longer to respond, but by 8 weeks, 97% of people prescribed Ilaris for CAPS will have responded.
Response is measured with laboratory tests and a doctor’s assessment of the person’s skin disease and symptoms, such as rash, fatigue, muscle pain, headache or migraine, sore or red eyes, and joint pain, being minimal or better.
Weight gain is a potential side effect of Ilaris treatment, with product information reporting at least 11% of people taking Ilaris gained weight. Surveys have shown weight gain is more common in females, aged 2 to 9 years old, who have been taking Ilaris for 1 to 6 months.
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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ilaris only for the indication prescribed.
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