What is this medication?

CANAKINUMAB (can a KIN ue mab) is used to treat certain types of arthritis in children and adults, such as Still's disease. It is also used to treat rare periodic fever syndromes including cryopyrin-associated periodic syndromes (CAPS), tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial Mediterranean fever (FMF). This medicine is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Ilaris

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• cancer
• hepatitis
• HIV or AIDS
• immune system problems
• infection (especially a virus infection such as chickenpox, cold sores, or herpes)
• low blood counts, like white cells
• recently received or scheduled to receive a vaccine
• tuberculosis, a positive skin test for tuberculosis or have recently been in close contact with someone who has tuberculosis
• an unusual or allergic reaction to canakinumab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection under the skin. It is given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• biologic medicines such as adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab
• live virus vaccines

This medicine may also interact with the following medications:

• abatacept
• baricitinib
• medicines that lower your chance of fighting an infection
• rilonacept
• rituximab
• sarilumab
• tocilizumab
• tofactinib
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medicine. Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medicine.

You will be tested for tuberculosis (TB) before you start this medicine. If your doctor prescribed any medicine for TB, you should start taking the TB medicine before starting this medicine. Make sure to finish the full course of TB medicine.

This medicine may increase your risk of getting an infection. Call your doctor or health care professional for advice if you get a fever, chills, or sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• signs and symptoms of infection like fever; chills; cough; sore throat; pain or trouble passing urine
• swelling, warmth, or redness of the skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• dizziness
• headache
• nausea, vomiting
• runny nose
• pain, redness, or irritation at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.