Ilaris 150 mg Vial Injection ( Refrigerator )

What Canakinumab is used for:

Canakinumab is used for treatment of the following inflammatory diseases:

Periodic fever syndromes:

• • Cryopyrin-associated periodic syndromes (CAPS),

• • Tumour necrosis factor receptor associated periodic syndrome (TRAPS),

• • Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD),

• • Familial Mediterranean fever (FMF).

• • Still’s disease including adult onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA)

• • Gouty arthritis

Do not use Canakinumab:

• • if you are allergic to Canakinumab or any of the other ingredients of this medicine.

• • if you have, or suspect you have, an active and severe infection.

Warnings and precautions:

Talk to your doctor or pharmacist before using Canakinumab:

• • if you currently have an infection or if you have had repeated infections or a condition such as a known low level of white blood cells which makes you more likely to get infections.

• • if you have or have ever had tuberculosis or direct contact with a person with an active tuberculosis infection.

• • if you have signs of a liver disorder such as yellow skin and eyes, nausea, loss of appetite, dark-coloured urine and light-coloured stools.

• • if you need to have any vaccinations.

Possible side effects :

• • These include infections of any kind, upper abdominal pain, pain in joints (arthralgia), drop in level of white blood cells (leukopenia), abnormal kidney function test results (creatinine renal clearance decreased, proteinuria), injection site reaction (such as redness, swelling, warmth and itching), candida, feeling dizzy, spinning sensation (dizziness or vertigo), pain in the back or muscles, feeling weak or very tired (fatigue, asthenia), drop in level of white your blood (lipid metabolism disorder), abnormal liver function test results, heartburn (gastro-oesophageal reflux disease), drop in level of blood cells which help prevent bleeding (platelets).

Other medicines and Canakinumab:

Tell your doctor if you are taking any of the following medicines:

Live vaccines:

• • You are advised to avoid being vaccinated with a type of vaccine called a live vaccine while you are being treated with Canakinumab.

• • Your doctor may want to check your vaccination history and give you any vaccinations that you have missed before you start treatment with Canakinumab.

• • Medicines called tumour necrosis factor (TNF) inhibitors, such as etanercept, adalimumab or infliximab.

• • These are used mainly in rheumatic and autoimmune diseases.

How to use Canakinumab:

Canakinumab is intended for subcutaneous use.

• • Cryopyrin- associated periodic syndromes (CAPS)

Still’s disease (SJIA and AOSD):

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

Gouty arthritis:

• • Your doctor will discuss with you the need to start or adjust a urate lowering therapy to lower the uric acid level in your blood.

• • The recommended dose of Canakinumab for adult gouty arthritis patients is 150 mg given as a single dose at the time of a gouty arthritis attack.

How to store Canakinumab:

• • 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.

• • Store in a refrigerator (2°C – 8°C). Do not freeze.

• • Keep the vial in the outer carton in order to protect from light.

• • The solution should be used immediately after first piercing the vial stopper to prepare the injection.

• • Do not use this medicine if you notice that the solution is not clear to opalescent.

• Any unused medicine must be discarded after withdrawal of the dose.