Our Therapies

ILARIS® Infusion Therapy

About ILARIS® Injection Therapy

ILARIS® (canakinumab) is an interleukin-1 beta blocker given as a subcutaneous injection, a small injection just under the skin rather than an infusion into a vein. It is approved for eight autoinflammatory conditions, meaning diseases where the immune system drives inflammation on its own rather than in response to an infection.

Interleukin-1 beta, usually shortened to IL-1β, is a signaling protein your body uses to start an inflammatory response. In autoinflammatory disease that signal is produced in excess, or the body is unusually sensitive to it, which produces recurring fevers, rashes, joint and muscle pain, and fatigue with no infection to explain them. ILARIS® binds IL-1β and neutralizes it before it can reach its receptor, so the signal never lands.

A useful contrast. Most of the medicines on our other pages either switch the immune system on so it can attack cancer, or quiet it broadly. ILARIS® does neither. It neutralizes one specific messenger protein, which is why it is used for conditions defined by that single signal rather than for autoimmune disease in general.

Your dose and your interval both depend on your diagnosis. This is unusual. On most of our pages the schedule is the same for everyone. Here, four different dosing patterns sit on one label, and which one applies to you is set by the condition being treated rather than by preference.

Still's disease, once a month. Patients 2 years and older who weigh at least 7.5 kg receive 4 mg/kg every four weeks, up to a maximum of 300 mg. This covers both adult-onset Still's disease and systemic juvenile idiopathic arthritis.

FMF, HIDS/MKD, and TRAPS, once a month. Patients weighing 40 kg or less receive 2 mg/kg every four weeks, which can be raised to 4 mg/kg if the response is not adequate. Patients over 40 kg receive 150 mg every four weeks, which can be raised to 300 mg.

CAPS, once every two months. This is the one group on an eight-week rather than a four-week interval. Patients 4 years and older weighing 15 to 40 kg receive 2 mg/kg every eight weeks, which can be raised to 3 mg/kg in children if the response is not adequate. Patients over 40 kg receive 150 mg every eight weeks.

Gout flares, a single dose when a flare happens. This is not ongoing therapy at all, and it is the only indication where dosing is not based on weight. Adults receive one 150 mg injection at the time of a flare. If another flare occurs and re-treatment is needed, at least 12 weeks must pass before the next dose.

Screening happens before your first dose. You are evaluated for active and latent tuberculosis, and a positive screen is treated before ILARIS® begins. You are checked for any active infection, since treatment is not given during an infection that needs medical attention. And your vaccinations are brought up to date, because live vaccines are avoided once treatment starts.

ILARIS® is not combined with TNF inhibitors. Blocking interleukin-1 and tumor necrosis factor at the same time has been associated with more serious infections without added benefit, so a TNF inhibitor is stopped before ILARIS® begins. ILARIS® is also contraindicated if you have a confirmed hypersensitivity to canakinumab or to any ingredient in the injection.

Where the injection is given. ILARIS® is administered by a healthcare professional, not self-injected at home the way some subcutaneous medicines are. It comes as a single-dose vial delivering 150 mg per mL. Many patients receive it here at Violet Health. A home health nurse service is also available through ILARIS® Companion in all 50 states and Puerto Rico, which your prescriber can request on your behalf at 1-866-972-8315.

Conditions treated by this therapy

ILARIS® is FDA-approved for people who are:

Adults and children 4 years and older living with cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS)
Adults and children living with tumor necrosis factor receptor associated periodic syndrome (TRAPS)
Adults and children living with hyperimmunoglobulin D syndrome (HIDS), also known as mevalonate kinase deficiency (MKD)
Adults and children living with familial Mediterranean fever (FMF)
Adults and children 2 years and older with active Still's disease, including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA)
Adults with gout flares for whom non-steroidal anti-inflammatory drugs and colchicine are contraindicated, are not tolerated, or do not work well enough, and for whom repeated courses of corticosteroids are not appropriate

A note on gout: ILARIS® treats the flare itself. It does not lower the uric acid that causes flares in the first place, so any urate-lowering medicine you take continues separately and is managed by your prescriber. This indication is also narrower than it first appears, since it applies only after the usual treatments have been ruled out.

A note on age: safety and effectiveness have not been established for systemic juvenile idiopathic arthritis in children under 2, for CAPS in children under 4, or for gout flares in children of any age. The age floor differs by condition, so a pediatric referral should name the specific diagnosis.

A note on combination therapy: ILARIS® is not recommended together with a TNF inhibitor. If you are currently taking one, your specialist will plan the transition before your first injection.

Your rheumatologist or immunologist will confirm whether this therapy is right for you before treatment begins.

ILARIS® Price

The cost of prescription medications can vary depending on your insurance coverage. If you're concerned about the price of your medication:

Contact your insurance provider to understand your coverage
Ask your doctor or pharmacist about lower-cost alternatives
Check with the drug manufacturer about financial assistance programs
Explore patient assistance options if you're uninsured or underinsured

Remember, many resources exist to help patients access necessary medications. Don't hesitate to ask for help if you're struggling with medication costs. No patient should go without necessary treatment due to financial limitations. If you have questions about financial assistance opportunities, contact a member of our Violet Health team.

What to Expect During ILARIS® Injection Therapy

When you arrive at a Violet Health location, our team will greet you by name and help you settle into a private, welcoming space. ILARIS® visits are short, and here is what a typical one looks like. Your care team will:

Ask about any signs of infection, including fever, chills, a new or lingering cough, warm or painful skin, or burning with urination, since infection is the main thing we watch for on this treatment
Check your vital signs and confirm your current weight, since every indication except gout is dosed by weight and children's doses change as they grow
Confirm before your first dose that tuberculosis screening is complete and that any latent infection has been treated
Review your vaccination record and confirm no live vaccine is planned during treatment
Review your other medicines and confirm you are not taking a TNF inhibitor
Give the injection just under the skin, rotating the site between the thigh, abdomen, upper arm, and upper outer buttock, and avoiding skin that is scarred, bruised, tender, or hardened
Stay with you and watch you for a short period afterward, since a hypersensitivity reaction, though uncommon, would show itself early
Protect your privacy and comfort throughout the visit

Plan for a very short visit. The injection itself takes moments, and most patients are in and out within 30 to 45 minutes once check-in and a brief observation period are included. This is the shortest treatment visit we offer. There is no IV line, no premedication, and no sedation, so most patients drive themselves.

Your rhythm depends on your diagnosis. Patients with Still's disease, FMF, HIDS/MKD, or TRAPS come in once every four weeks. Patients with CAPS come in once every eight weeks, so half as often. Patients treated for gout flares do not have a standing appointment at all.

Gout flare visits work differently. You come in when a flare starts rather than on a schedule, and you receive a single 150 mg injection. Call us early in a flare so we can see you promptly. If you need treatment for a later flare, at least 12 weeks must have passed since your last dose, so it helps to know that date.

Children's doses are recalculated as they grow. For pediatric patients the weight we record at each visit is not a formality. Dose and, in CAPS, the weight band that decides between a milligram-per-kilogram dose and the flat 150 mg dose both depend on it.

Home administration may be an option. ILARIS® Companion offers a home health nurse service in all 50 states and Puerto Rico. It is requested by your prescriber rather than arranged by you, and the requesting physician receives confirmation of each visit. If travel to an appointment every four or eight weeks is difficult, ask your specialist whether this is right for you.

What improvement looks like. In the periodic fever syndromes and Still's disease, many people notice fewer and milder flares over the first weeks rather than an immediate change, and the goal is steady control between doses. In gout, relief is measured in days rather than weeks. Keep attending your scheduled appointments and tell your specialist how you are doing at each visit.

ILARIS® Side Effects

ILARIS® is generally well tolerated, and most people get through their injections without difficulty. The consideration that matters most is infection risk, because the medicine blocks part of the signal your body uses to mount an inflammatory response. The common side effects differ noticeably by condition, so the lists below are grouped by what the clinical trials found in each group.

In CAPS, the most common side effects were:

Sore throat and runny nose (nasopharyngitis), rhinitis, pharyngitis, bronchitis, and influenza
Diarrhea, nausea, and gastroenteritis
Headache, muscle and bone pain, weight gain, and vertigo

In TRAPS, HIDS/MKD, and FMF, the most common were: injection site reactions and nasopharyngitis. This is a short list, and the profile in these conditions is milder than in CAPS.

In Still's disease, the most common were: infections, chiefly nasopharyngitis and upper respiratory tract infections, along with abdominal pain and injection site reactions.

In gout flares, the most common were: nasopharyngitis, upper respiratory tract infection, urinary tract infection, raised triglycerides in the blood, and back pain. Because this indication involves a single dose rather than ongoing therapy, the overall exposure is much smaller.

Injection site reactions. Redness, swelling, warmth, or itching where the needle went in is the side effect most specific to this medicine, and it is one the infusion pages do not have. Reactions are usually mild, settle on their own within a day or two, and are less likely if the site is rotated each time. Tell your nurse if a site becomes painful, hardens, or does not clear.

Although rare, serious side effects can occur. Please alert our clinical staff or seek medical attention immediately if you experience any of the following symptoms:

Serious infection: fever of 100.4 degrees Fahrenheit or higher, chills, flu-like symptoms, unusual tiredness, a cough that will not clear, warm or red or painful skin, or burning with urination. Infections are most often of the upper respiratory tract and usually respond to standard treatment, but unusual and opportunistic infections including aspergillosis, atypical mycobacterial infection, cytomegalovirus, and shingles have been reported. ILARIS® is not given during an infection that needs medical attention, and it is stopped if a serious infection develops.
Tuberculosis: a persistent cough, coughing up blood, night sweats, a low-grade fever, or unexplained weight loss, during or after treatment. You are screened before starting and any latent infection is treated first.
Allergic reaction: hives, trouble breathing, wheezing, or swelling of the face, eyelids, lips, or tongue. Seek emergency care immediately. ILARIS® should not be given at all to anyone with a confirmed hypersensitivity to canakinumab.
A severe skin reaction with fever (DRESS): a widespread rash together with fever, swollen glands, or facial swelling, usually appearing weeks after a dose. This is treated as an emergency, and ILARIS® is stopped immediately.
Macrophage activation syndrome, in Still's disease: a fever lasting more than three days, a cough that will not go away, redness or warmth or swelling in one part of the body, worsening of your usual Still's symptoms, unusual bruising or bleeding, or confusion. This is a known, life-threatening complication of Still's disease itself, and infection or a disease flare can trigger it. Report these symptoms right away rather than waiting for your next appointment.
Severe or persistent vertigo: a spinning sensation or loss of balance. Vertigo was reported as a serious reaction in the CAPS trials specifically. Tell us if it occurs, and do not drive while it is happening.

A note on long-term risk. The effect of blocking interleukin-1 on the development of cancer is not known. As with other medicines that suppress part of the immune system, there may be an increased risk, and your specialist will weigh that against the benefit of controlling your disease.

Vaccines need planning. Live vaccines are avoided during treatment. Bring all recommended vaccinations up to date before you start, and tell any other provider that you receive ILARIS® before they vaccinate you, since the medicine may make some vaccines less effective. If you were treated during pregnancy, the risks and benefits of live vaccines for your baby should be considered for at least four to 12 months after your last dose, so let your pediatrician know.

Good to know: ILARIS® carries no boxed warning. There are also no immune-mediated warnings of the kind that come with the checkpoint inhibitors described on our other pages. Where the dose does change, it is usually raised rather than lowered, because an inadequate response is the more common reason to adjust. If a serious problem arises, ILARIS® is held or stopped.

Pregnancy and breastfeeding. There is not enough information to know whether ILARIS® harms an unborn baby. Like other antibodies of its kind it crosses the placenta, mainly in the third trimester, and may suppress the baby's immune system for a period after birth. The label does not set a contraception window, which is a notable difference from the cancer medicines on our other pages where three to 12 months is typical. Tell your care team if you are pregnant, planning a pregnancy, or breastfeeding.

Information to Include With Your Referral

Because dose, interval, and eligibility all change depending on which of the eight conditions is being treated, referrals for ILARIS® need more detail than most. Including the following helps us schedule the right appointment the first time:

The specific diagnosis, named rather than grouped. CAPS, TRAPS, HIDS/MKD, FMF, adult-onset Still's disease, systemic juvenile idiopathic arthritis, and gout flares each carry a different schedule
Genetic testing results where they were obtained, including NLRP3 for CAPS, MEFV for FMF, TNFRSF1A for TRAPS, and MVK for HIDS/MKD
Current weight and date it was taken, plus age for pediatric patients, since both determine the dose and the weight band
The intended dose and interval, including whether an increased dose has been authorized for an inadequate response
For gout referrals, documentation that NSAIDs and colchicine are contraindicated, not tolerated, or inadequate, and that repeated corticosteroid courses are not appropriate, since the indication depends on it
For gout re-treatment, the date of the last ILARIS® dose, so the 12-week interval can be confirmed, along with current urate-lowering therapy and recent serum urate
For Still's disease, whether the diagnosis is adult-onset or systemic juvenile, any history of macrophage activation syndrome, and the current corticosteroid and DMARD plan
Tuberculosis screening results, with confirmation that any latent infection has been treated
Hepatitis B, hepatitis C, and HIV status, and any history of recurrent, chronic, or opportunistic infection
Vaccination record, including whether any live vaccine is planned or was given recently
Current and recent biologics, with particular attention to TNF inhibitors and a stop date, plus any prior interleukin-1 therapy such as anakinra or rilonacept and how the patient responded
Any known hypersensitivity to canakinumab or to an excipient, since that is a contraindication rather than a caution
Baseline complete blood count with neutrophil count, liver function, and a lipid panel
Pregnancy, breastfeeding, or planned pregnancy status
Whether home nurse administration through ILARIS® Companion is being requested instead of visits to our center