What is Ilaris?

Canakinumab injection is used to treat cryopyrin-associated periodic syndromes (CAPS). This also includes familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). CAPS is a rare, inherited disease of the immune system. It occurs when the body produces too much of a chemical called interleukin-1 beta. This chemical causes inflammation, and patients with CAPS may have a fever, headache, skin rash, joint or muscle pain, or unusual tiredness or weakness.

Canakinumab helps prevent inflammation by keeping the interleukin-1 beta from working properly. This medicine also treats adults and children with other autoinflammatory periodic fever syndromes, such as tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial Mediterranean fever (FMF).

Canakinumab is also used to treat active systemic juvenile idiopathic arthritis (SJIA) in children 2 years of age and older.

This medicine is to be given only by or under the direct supervision of a doctor.

A nurse or other trained health professional will give you or your child this medicine in a hospital or clinic setting. This medicine is given as a shot under your skin.

This medicine is given every 8 weeks for CAPS and every 4 weeks for TRAPS, HIDS/MKD, FMF, and SJIA.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of canakinumab injection in children with TRAPS, HIDS/MKD, and FMF. However, safety and efficacy have not been established in children with CAPS, FCAS, or MWS younger than 4 years of age and in children with SJIA younger than 2 years of age.

Appropriate studies on the relationship of age to the effects of canakinumab injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Tofacitinib

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hepatitis B, history of or
• Hepatitis C, history of or
• Immune system problem (eg, HIV or AIDS) or
• Infection, active or
• Tuberculosis, active or history of—Use with caution. May make these conditions worse.

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly.

You will need to have a skin test for tuberculosis before you or your child start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test.

Your body's ability to fight an infection may be reduced while you are being treated with canakinumab. It is very important that you call your doctor right away if you or your child have a fever, chills, cough, hoarseness, lower back or side pain, or painful or difficult urination.

Using this medicine may increase your risk of cancer. Talk to your doctor if you have concerns about this risk.

Canakinumab may cause allergic reactions. Tell your doctor right away if you have a rash, itching, lightheadedness or dizziness, swelling of the face, tongue, and throat, trouble breathing or swallowing, or chest pain after you or your child receive the medicine.

Do not get any immunizations (vaccines), especially the live vaccines (eg, nasal flu virus vaccine) without your doctor's approval while you are being treated with this medicine.

This medicine may cause a life-threatening condition called macrophage activation syndrome (MAS). This usually occurs in patients with rheumatic conditions, including SJIA, and must be treated immediately. Tell your doctor right away if you have a fever that lasts longer than 3 days, a cough that does not go away, redness in one part of your body, or warm feeling or swelling of your skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.