150 mg / ml injection solution
canakinumab

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects , talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What Ilaris is and what it is used for
2. What you need to know before you use Ilaris
3. How to use Ilaris
4. Possible side effects
5. How to store Ilaris
6. Contents of the packaging and other information

1. What Ilaris is and what it is used for

What Ilaris is

Ilaris contains the active substance kanakinumab, a monoclonal antibody, which belongs to a group of medicines called interleukin inhibitors. It blocks the effect of a substance in the body called interleukin 1-beta (IL 1-beta), which is found in increasing amounts in inflammatory diseases.

What Ilaris is used for

Ilaris is used to treat the following inflammatory diseases:

  • Periodic fever syndromes:
    • Cryopyrin-Associated Periodic Syndrome (CAPS),
    • Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS),
    • Hyperimmunoglobulin D syndrome (HIDS) / mevalonate kinase deficiency (MKD),
    • Familial Mediterranean fever (FMF).
  • Still’s disease including Still’s disease in adults (AOSD) and systemic juvenile idiopathic arthritis (sJIA)
  • Rheumatoid arthritis

Further information on each of these diseases is given below.

Periodic fever syndromes

Ilaris is used in adults and children aged 2 years and older to treat the following:

  • Cryopyrin-Associated Periodic Syndrome (CAPS) – this is a group of autoinflammatory diseases, which include:
    • Muckle-Wells Syndrome (MWS),
    • systemic inflammatory disease with neonatal onset (NOMID), also known as chronic neurological skin and joint syndrome in children (CINCA),
    • severe forms of familial autoinflammatory cold syndrome (FCAS) / familial cold urticaria (FCU), which appear with additional signs and symptoms than those found in urticaria-induced colds.
  • Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS),
  • Hyperimmunoglobulin D syndrome (HIDS) also known as mevalonate kinase deficiency (MKD)
  • Familial Mediterranean Fever (FMF): Ilaris is used to treat FMF. Ilaris can be used with colchicine, if appropriate.

In patients with periodic fever syndrome (CAPS, TRAPS, HIDS / MKD, and FMF), the body produces too much IL 1-beta. This can lead to fever, headache, fatigue, skin rash, or joint and muscle pain. By blocking the activity of IL 1-beta, Ilaris can improve these symptoms.

Contact a doctor immediately

  • If you have ever had an atypical rash or dandruff after taking Ilaris.
    The severe skin reaction DRESS (drug reaction with eosinophilia and systemic symptoms) has been reported rarely in association with treatment with Ilaris, particularly in patients with systemic juvenile idiopathic arthritis (sJIA). Seek medical attention immediately if you get an atypically widespread skin rash, which can occur in combination with high body temperature and enlarged lymph nodes .

Still illness

Ilaris is used in adults, adolescents, and children to treat active Stills disease including Stills disease in adults (AOSD) and systemic juvenile idiopathic arthritis (sJIA) in patients aged 2 years and older if other treatments have not worked well enough. Ilaris can be used alone or in combination with methotrexate.

Still, ‘s diseases including sJIA and AOSD are inflammatory diseases. They can cause pain, swelling, and inflammation in one or more joints, as well as rash and fever. A pro-inflammatory protein called IL 1-beta plays an important role in the inflammatory processes in Still’s disease. Ilaris blocks the activity of IL 1-beta, which may improve the signs and symptoms of Still’s disease.

Rheumatoid arthritis

Ilaris is used in adults to treat the symptoms of frequent rheumatoid arthritis attacks if other treatments have not had sufficient effect.

Gouty arthritis is caused by the formation of urate crystals. These crystals cause large amounts of IL 1-beta to form, which in turn can lead to symptoms such as sudden and severe pain, redness, feeling hot, and swelling in a joint (a so-called gout attack). By blocking the activity of IL 1-beta, Ilaris may lead to an improvement in these symptoms.

2. What you need to know before using Ilaris

Do not use Ilaris

  • If you are allergic to kanakinumab or any of the other ingredients of this medicine (listed in section 6).
  • If you have one or suspect you have an active and severe infection .

Warnings and cautions

Talk to your doctor before using Ilaris if any of the following apply to you:

  • If you currently have an infection or if you have previously had repeated infections or if you have a condition that makes it easier for you to get an infection , such as low content of white blood cells .
  • If you have or have had tuberculosis or have been in direct contact with a person with an ongoing tuberculosis infection. Your doctor must check if you have tuberculosis by performing a special test.
  • If you have signs of a liver problem, such as yellowing of the skin and eyes, nausea, decreased appetite, dark urine and light stools.
  • If you need to be vaccinated. It is recommended that you avoid certain types of vaccines (live vaccines) while you are being treated with Ilaris (see also “Other medicines and Ilaris”).

Still illness

  • Patients with Still’s disease can develop a condition called macrophage activation syndrome (MAS), which can be life-threatening. Your doctor will monitor you for potential triggers of MAS that include infection and reactivation of the underlying Stills disease ( relapse ).

Children and young people

  • CAPS, TRAPS, HIDS / MKD, FMF and sJIA: Ilaris can be given to children aged 2 years and older.
  • Gouty arthritis: Ilaris is not recommended for children or adolescents under 18 years.

Other medicines and Ilaris

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

  • Live vaccines: You are advised to avoid being vaccinated with a certain type of vaccine, so-called “live vaccines”, while you are being treated with Ilaris. Your doctor may want to check which vaccinations you have received in the past and give you all the vaccinations you are missing before starting treatment with Ilaris. If you need to get a live vaccine after starting treatment with Ilaris, discuss this with your doctor. A live vaccine should normally be given at least 3 months after your last injection of Ilaris and 3 months before the next one.
  • Drugs called tumor necrosis factor ( TNF ) inhibitors, e.g. etanercept, adalimumab or infliximab. These are mainly used in rheumatic and autoimmune diseases, they should not be used with Ilaris as it may increase the risk of infection .

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  • You are advised to avoid becoming pregnant and must use appropriate contraception while using Ilaris and for at least 3 months after the last treatment with Ilaris. It is important that you tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Your doctor will talk to you about the possible risk of taking Ilaris during pregnancy.
  • If you were given kanakinumab while you were pregnant, it is important that you inform your child’s doctor or nurse before giving vaccinations to your child. Your baby should not receive live vaccines until at least 16 weeks after receiving your last dose of kanakinumab before delivery.
  • It is not known if Ilaris passes into breast milk. Your doctor will talk to you about the possible risk of taking Ilaris while breast-feeding.

Driving and using machines

Treatment with Ilaris can cause a tingling sensation (dizziness or vertigo ) or intense fatigue ( asthenia ), which may affect your ability to drive or use tools and machines. If you feel a tingling sensation or feel tired, do not drive or use any tools or machines until you feel normal again.

3. How to use Ilaris

Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

Tell your doctor about your health condition and any symptoms before taking or receiving Ilaris (see section 2). If necessary, your doctor may decide to postpone or discontinue your treatment.

Ilaris should be given subcutaneously. This means that it should be injected with a short needle into the adipose tissue just under the skin.

If you have gouty arthritis, your treatment will be monitored by a specialist. Ilaris should then only be injected by healthcare professionals.

If you have CAPS or Still’s disease (AOSD or sJIA), you can give yourself an injection with Ilaris when you have received proper training or a caregiver can inject it for you.

How much Ilaris to use

Cryopyrin-Associated Periodic Syndrome (CAPS)

The recommended starting dose of Ilaris is:

  • Adults, adolescents and children from 4 years of age
    • 150 mg for patients weighing over 40 kg
    • 2 mg / kg for patients weighing between 15 kg and 40 kg
    • 4 mg / kg for patients weighing between 7.5 kg and less than 15 kg
  • Children aged 2 or 3 years
    • 4 mg / kg for patients weighing 7.5 kg or more

Ilaris is injected every 8 weeks as a single dose.

  • If you have not responded well enough to the treatment after 7 days, your doctor may give you an additional dose of 150 mg or 2 mg / kg.
  • If you respond well enough to the second dose one, treatment will be continued at 300 mg or 4 mg / kg every 8 weeks.
  • If you do not respond well enough to the increased dose , a third dose of Ilaris of 300 mg or 4 mg / kg may be given.
  • If you respond well enough to the third dose , your treatment may be continued at 600 mg or 8 mg / kg every 8 weeks.

For children who have received a starting dose of 4 mg/kg and who have not responded well enough after 7 days, the doctor may give a second dose of 4 mg/kg. If the child then responds well enough to this, treatment can be continued at 8 mg/kg every 8 weeks.

Tumor necrosis factor receptor-associated periodic syndrome (TRAPS), Hyper immunoglobulin D syndrome (HIDS) / mevalonate kinase deficiency (MKD), and Familial Mediterranean fever (FMF)

The recommended starting dose of Ilaris is:

  • Adults and children aged 2 years or older
    • 150 mg for patients weighing more than 40 kg
    • 2 mg / kg for patients weighing between 7.5 kg and less than 40 kg

Ilaris is injected every 4 weeks as a single dose.

  • If you have not responded well enough to the treatment after 7 days, your doctor may give you an additional dose of 150 mg or 2 mg / kg.
  • If you respond well enough to this, treatment will be continued at 300 mg or 4 mg / kg every 4 weeks.

Still’s a disease (sJIA and AOSD)

The recommended dose is one of Ilaris with Still’s disease with a body weight of 7.5 kg and above is 4 mg/kg (up to a maximum of 300 mg). Ilaris is injected every 4 weeks as a single dose.

Rheumatoid arthritis

Your doctor will discuss with you if a urate-lowering treatment needs to be started or adjusted to lower the uric acid level in your blood.

The recommended dose of Ilaris for adult patients with gouty arthritis is 150 mg as a single dose during an attack.

If you need another treatment with Ilaris and provided that the last treatment worked, you must wait at least 12 weeks before receiving the next dose.

How to inject Ilaris on yourself or a patient

If you are a patient with CAPS, TRAPS, HIDS / MKD, or Still’s a disease (AOSD or sJIA) or a health care provider for patients with any of these conditions, you can give the injection you Ilaris yourself After proper training in the correct injection technique.

  • The patient or caregiver and the doctor should decide together who should give the injections with Ilaris.
  • The doctor or nurse will show you how to give the injection you with Ilaris.
  • Do not try to inject yourself if you have not received adequate training or if you are not sure how to do it.
  • Ilaris 150 mg / ml injection solution supplied in a vial for single use to a patient.
  • Never reuse leftover solution.

For instructions on how to perform the injection with Ilaris, read the “User Manual” at the end of this leaflet. If you have any further questions, ask your doctor, pharmacist, or nurse.

How long to use Ilaris

  • CAPS, TRAPS, HIDS / MKD, FMF or Still’s disease (AOSD or sJIA): Your doctor will decide how long you should continue with Ilaris.
  • Gouty arthritis: If you have a gouty arthritis attack, you will receive Ilaris as a single dose. If you get another attack, your doctor may consider giving you a new dose of Ilaris, but not earlier than 12 weeks after the first dose .

If you use more Ilaris than you should

If you have accidentally injected more Ilaris than the recommended dose, it is probably not that serious, but you should still inform your doctor, pharmacist, or nurse as soon as possible.

If you forget to use Ilaris

If you have CAPS, TRAPS, HIDS / MKD, FMF, or Stills disease (AOSD or sJIA) and forgot to inject one dose of Ilaris, inject the next dose as soon as you remember. Then talk to your doctor about when to inject the next dose. You should then continue with the injections at the recommended interval, as before.

If you stop using Ilaris

Discontinuing your treatment with Ilaris may make your condition worse. Do not stop taking Ilaris unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

Some side effects can be serious. Tell your doctor immediately if you notice any of the side effects below:

  • Fever that lasts longer than 3 days or other symptoms that indicate a serious infection . These can be tremors, chills, malaise, loss of appetite, body aches, usually associated with a sudden illness, sore throat or sore mouth, cough, mucus, chest pain, difficulty breathing, ear pain, persistent headache or local redness, feeling hot or swollen or inflamed. in the connective tissue ( cellulite ). These symptoms may be due to a serious infection , an unusual infection ( opportunistic infection ) or may be related to low levels of white blood cells (called leukopenia or neutropenia).). Your doctor may check your blood regularly if it is considered necessary.
  • Allergic reactions with rash and itching and possibly also hives , difficulty breathing or swallowing, dizziness, palpitations or low blood pressure .

Other side effects of Ilaris can be:

Very common (may affect more than 1 in 10 people):

  • Infection is of all kinds. These may include:
    • Respiratory tract infections such as pneumonia , influenza , sore throat, runny nose, nasal congestion, sneezing, feeling of pressure or pain in cheeks or forehead with or without fever ( pneumonia , bronchitis , influenza , sinusitis, rhinitis , pharyngitis , tonsillitis , nasopharyngitis ), upper respiratory tract.
    • Other infections such as ear infection, skin infection ( cellulite ), stomach pain and malaise ( gastroenteritis ) and painful and frequent urination with or without fever (urinary tract infection).
  • Abdominal pain in the upper abdomen.
  • Joint pain ( arthralgia ).
  • Low level of white blood cells ( leukopenia ).
  • Deviating renal function values ​​(decreased creatinine clearance , proteinuria ).
  • Injection site reaction (such as redness , swelling, feeling hot and itching ).

Common (may affect up to 1 in 10 people):

  • Candida – vaginal fungal infection ( vulvovaginal candidiasis ).
  • Dizziness, tingling sensation ( vertigo ).
  • Back pain or muscles.
  • Feeling weak or very tired (tiredness, asthenia ).
  • Low levels of white blood cells that help prevent infection ( neutropenia ).
  • Abnormal blood triglyceride levels (disturbed fat metabolism).
  • Deviating liver function values ​​(elevated transaminases ) or high levels of bilirubin in the blood, with or without yellowing of the skin and eyes (hyperbilirubinemia).

Uncommon (may affect up to 1 in 100 people):

  • Heartburn ( gastroesophageal reflux disease ).
  • Low levels of blood cells that help prevent bleeding ( platelets ).

Tell your doctor or your child’s doctor immediately if you notice any of these symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Ilaris

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the label and carton. The expiration date is the last day of the specified month.
  • Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
  • Keep the vial in the outer carton. Sensitive to light.
  • The solution should be used immediately after the first opening (piercing the rubber stopper) to prepare injection one.
  • Do not use this medicine if you notice that the solution is not ready for opalescence or if it contains particles.
  • Any unused product should be discarded after a single dose has been injected.
  • 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is kanakinumab. One vial contains 150 mg kanakinumab in 1 ml solution.
  • The other ingredients are mannitol, histidine, histidine hydrochloride monohydrate, polysorbate 80, water for injections.

What the medicine looks like and contents of the pack

  • Ilaris is supplied as a solution for injection in a 2 ml glass vial .
  • The solution is a clear to opalescent liquid. It is colorless or may have a light brownish-yellow hue. Do not use if the liquid contains clearly visible particles, is cloudy or is clearly brown.
  • Ilaris is available in packs containing 1 vial .

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 SwedenNovartis Sverige ABTel: +46 8 732 32 00
LatviaSIA Novartis BalticsTel: +371 67 887 070 United  KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

Muhammad Nadeem

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