What is it and how is it used?
Ilaris is used in adults, adolescents and children aged 4 years and older with body weight above 15 kg to treat the following auto-inflammatory diseases, which are collectively known as Cryopyrin-Associated Periodic Syndromes (CAPS):
- Muckle-Wells Syndrome (MWS),
- Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also called Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA),
- Severe forms of Familial Cold Autoinflammatory Syndrome (FCAS) / Familial Cold Urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.
Ilaris belongs to a group of medicines called interleukin inhibitors. The active substance in Ilaris is canakinumab, a fully-human monoclonal antibody. It blocks the activity of a substance called interleukin-1 beta (IL-1 beta). In patients with CAPS, the body produces excessive amounts of IL-1 beta. This may lead to symptoms such as fever, headache, fatigue, skin rash, or painful joints and muscles. By blocking the activity of IL-1 beta, canakinumab leads to an improvement in these symptoms.
If you have any questions about how Ilaris works or why this medicine has been prescribed for you, ask your doctor.
What do you have to consider before using it?
Do not use Ilaris
Take special care with Ilaris
Before using Ilaris, tell your doctor if any of the following applies to you:
- if you currently have an infection or if you have a history of recurring infections or a condition which makes you vulnerable to infections.
- if you require vaccinations. You are advised to avoid a certain type of vaccination (also called live vaccines) while being treated with Ilaris (see also “Using other medicines”). During treatment with Ilaris, tell your doctor immediately if you experience any of the following symptoms:
- prolonged fever (i.e. fever lasting longer than 3 days) or any other symptoms possibly related to an infection, such as prolonged cough, prolonged headache or localised redness, warmth or swelling of your skin.- signs of an allergic reaction such as difficulty breathing, nausea, dizziness, skin rash, palpitations or low blood pressure.
- signs of liver disorders such as yellow skin and eyes, nausea, loss of appetite, dark-coloured urine and light-coloured stools.
Ilaris is not recommended for children younger than 4 years of age or who weigh less than 15 kg.
Using other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
- You are advised to avoid a certain type of vaccination known as “live vaccines” while being treated with Ilaris. Your doctor may want to check your vaccination history and give you any vaccinations that you have missed before you start treatment with Ilaris. Should vaccination with live vaccines be necessary after initiation of Ilaris treatment, you are recommended to wait for at least 3 months after the last Ilaris injection and before the next one.
- Medicines called tumour necrosis factor (TNF) inhibitors predominantly used in rheumatoid and autoimmune diseases (such as etanercept, adalimumab or infliximab) should not be used with Ilaris because this may increase the risk of infections.
Pregnancy and breast-feeding
- Ilaris has not been studied in pregnant women. You are advised to avoid becoming pregnant and must use adequate contraception while using Ilaris and for at least 3 months after the last Ilaris treatment. It is important to tell your doctor if you are pregnant, if you think you may be pregnant or if you plan to get pregnant. Your doctor will discuss with you the potential risk of taking Ilaris during pregnancy.
- It is not known whether Ilaris passes into human milk. Your doctor will discuss with you the potential risks of taking Ilaris before breast-feeding.
Driving and using machines
Some symptoms associated with CAPS or with Ilaris treatment, such as a spinning sensation (known as vertigo), may affect your ability to drive or use machines. If you feel a spinning sensation, do not drive or operate any tools or machines until you are feeling normal again.
Ask your doctor, nurse or pharmacist for advice before taking any medicine.
How is it used?
Always use Ilaris exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure.
Ilaris is intended for subcutaneous use. This means that it is injected through a short needle into the fatty tissue just under the skin.
How much Ilaris to use
The recommended dose of Ilaris for CAPS patients is:
- 150 mg for patients with body weight of more than 40 kg.
- 2 mg/kg for patients with body weight between 15 kg and 40 kg.
Ilaris is injected as a single dose every 8 weeks.
If you have not sufficiently responded to treatment after 7 days, your doctor may consider giving you a repeat dose of 150 mg or 2 mg/kg. After this you will continue to receive this higher dose of 300 mg or 4 mg/kg.
Injecting Ilaris yourself
After proper training in the correct injection technique, you may inject Ilaris yourself. - You and your doctor should decide together whether or not you will inject Ilaris yourself. - Your doctor or nurse will show you how to inject yourself.
- Do not try to inject yourself if you have not been properly trained or if you are not sure how to do it.
For instructions on how to inject yourself with Ilaris, please read the section “Instructions for use” at the end of this leaflet. If you have any questions, contact your doctor, nurse or pharmacist.
How long to use Ilaris
You should continue using Ilaris for as long as your doctor tells you.
If you use more Ilaris than you should
- If you accidentally inject more Ilaris than the recommended dose, it is unlikely to be serious, but you should inform your doctor, nurse or pharmacist as soon as possible. - You should not inject Ilaris earlier than 8 weeks after the previous dose, unless your doctor tells you to. If you accidentally inject Ilaris sooner than you should, you should also inform your doctor, nurse or pharmacist as soon as possible.
If you forget to use Ilaris
If you have forgotten to use a dose of Ilaris, inject the next dose as soon as you remember, then contact your doctor to discuss when you should take the next dose. You should then continue with injections at 8-week intervals as before.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
What are possible side effects?
Like all medicines, Ilaris may cause side effects, although not everybody gets them. Most of the side effects are mild to moderate and will generally disappear a few days to a few weeks after treatment.
Side effects may occur with certain frequencies, which are defined as follows:
Potentially serious side effects (very common):
- Prolonged fever (i.e. fever lasting longer than 3 days) or any other symptoms possibly related to an infection, such as prolonged cough, prolonged headache or localised redness, warmth or swelling of your skin.
If you experience any of these, tell your doctor immediately.
Very common side effects:
- Spinning sensation (vertigo).
- Injection site reaction (such as redness, swelling, warmth and itching).
Common side effects:
- Sore throat and nose (nasopharyngitis).
Potential side effects:
These side effects could potentially occur but have either not been reported as a side effect with Ilaris or have been reported rarely during the use of Ilaris but seem to be unrelated to Ilaris. - Signs of an allergic reaction such as difficulty breathing, nausea, dizziness, skin rash, palpitations or low blood pressure. If you experience any of these symptoms, tell your doctor immediately.
- Signs of liver disorders such as yellow skin and eyes, nausea, loss of appetite, dark-coloured urine and light-coloured stools.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Ilaris after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package in order to protect from light.
After reconstitution, from a microbiological point of view, the product should be used immediately. However, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
Do not use Ilaris if you notice that the solution is not clear to opalescent or contains particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
