Canakinumab belongs to the class of medications called immunomodulatory agents. It reduces the activity of interleukin-1 beta (IL-1β), a chemical produced by the body as part of the body's defenses against infection, causing fever, rash, swelling, and pain.

Canakinumab is used to treat a number of immune conditions associated with overproduction of IL-1β. These include:

• cryopyrin-associated periodic syndromes (CAPS)
• systemic juvenile idiopathic arthritis (SJIA)
• tumour necrosis factor receptor associated periodic syndrome (TRAPs)
• hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD)
• familial Mediterranean fever (FMF)
• Still's Disease, including Systemic Idiopathic Juvenile Arthritis (SJIA)

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Canakinumab is given by subcutaneous (under the skin) injection, usually in the front of the thigh or abdomen. The dose and how often it is given depends on the condition being treated and is based on body weight.

Your doctor will adjust your dose depending on how well you respond to and tolerate this medication. Canakinumab is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses) and can teach you how to give yourself the injection at home. Do not attempt to inject this medication on your own until you completely understand how to inject a dose. If you are unsure of how to prepare or inject a dose, ask a health care professional to clarify for you. If you are having difficulty giving yourself injections, ask a family member or other caregiver for help if they are willing to become involved with your treatment and are willing to learn how to give you your injections.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible, then contact your doctor to determine when you should take your next dose. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Before injecting the medication, remove it from the refrigerator to allow it to warm to room temperature. Check the solution to ensure that it is clear to opalescent and colourless to slightly brownish-yellow, with no particles in it. If the solution is not clear and colourless, discard the medication safely and use a new vial.

Store this medication in the refrigerator between 2°C and 8°C in its original packaging to protect it from light. Keep it out of sight and reach of children.

Solution for Injection
Each mL of sterile, clear to opalescent, colourless to slightly brownish yellow solution contains 150 mg of canakinumab. Nonmedicinal ingredients: mannitol, L-histidine, L-histidine HCL monohydrate, polysorbate 80, and water for injection.

Do not use canakinumab if you:

• are allergic to canakinumab or any ingredients of the medication
• have an active, severe infection

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• back pain
• cold symptoms (e.g., cough, sore throat with runny nose, stuffy nose, sneezing, forehead pain, fever)
• diarrhea
• dizziness
• heartburn
• nausea
• headache
• redness, swelling, warmth, or itching at the injection site
• spinning sensation
• unexplained weakness or fatigue
• vaginal yeast infection (e.g., vaginal odour, curd-like discharge, itching)
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• cough that does not go away
• fever, sore throat, or mouth sores
• flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
• increased blood pressure
• signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., abdominal pain, dark urine or pale stools, easy bruising, yellow eyes or skin)
• signs of pneumonia (e.g., fever, chills, shortness of breath, cough)
• signs of tuberculosis (e.g., persistent cough, weight loss, low fever)
• swollen lymph glands
• symptoms of tonsillitis (e.g., sore throat, fever, red or swollen tonsils cough, difficulty swallowing)
• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
• worsening of arthritis symptoms for people with Systemic Juvenile Idiopathic Arthritis

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood pressure: This medication can cause an increase in blood pressure. Your blood pressure should be monitored after starting this medication. If you have a history of high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Cancer risks: People taking this medication may have a higher risk of developing certain types of cancer. Talk to your doctor about cancer screening and your risk of cancer.

Dizziness: Canakinumab may cause dizziness or a spinning sensation, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.

Serious infections: Canakinumab can affect the way your body's natural defences work to fight infection. This makes the body more likely to develop infections due to bacteria, viruses, and fungi. This effect is increased if you are taking canakinumab with other medications that reduce the body's ability to fight infection. For some people, these infections have been fatal. If you have a history of chronic or frequent infections, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stop taking the medication and tell your doctor right away if you notice symptoms of a serious infection, such as fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in the sputum, shortness of breath, night sweats, weight loss, nausea, vomiting, diarrhea, frequency of urination or burning while passing urine, redness or swelling of skin or joint, cold sores, tooth pain, or new or worsening pain in any part of the body.

Still's disease: People with Still's disease can develop a serious and potentially fatal condition called macrophage activation syndrome (MAS). Contact your doctor immediately if you notice worsening of your Still's disease symptoms, or if you have symptoms of an infection such as fever, cough, redness, warmth, or swelling of your skin.

Tuberculosis: For people who have latent tuberculosis (TB) infection (the bacteria causing TB are alive in the body but are not active) the use of canakinumab may cause the tuberculosis bacteria to become active. Some people who have had tuberculosis (a lung infection) in the past have had this infection return when they are using canakinumab. Your doctor will likely want to do a TB skin test before you begin using this medication. If you have a history of tuberculosis, or have come into recent contact with someone who has tuberculosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of TB such as unexplained weight loss, loss of appetite, fever, fatigue, chills, or night sweats contact your doctor as soon as possible.

Vaccinations: People taking this medication should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Women who may become pregnant while using this medication should use effective birth control while using canakinumab and for 3 months after the last dose. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if canakinumab passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 2 years of age or those having a body weight of less than 9 kg.

There may be an interaction between canakinumab and any of the following:

• anakinra
• anti-tumour necrosis factor medications (e.g., adalimumab, certolizumab pegol, etanercept, infliximab, lenalidomide, pomalidomide, thalidomide)
• bacillus Calmette-Guérin (BCG)
• baricitinib
• cladribine
• denosumab
• echinacea
• fingolimod
• leflunomide
• natalizumab
• ocrelizumab
• ozanimod
• pimecrolimus
• roflumilast
• siponimod
• tacrolimus
• tofacitinib
• upadacitinib
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.