Canakinumab (human)(recombinant)(murine) Solution for injection

What is this medicine?

CANAKINUMAB is used to treat familial cold autoinflammatory syndrome and Muckle-Wells syndrome. 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.

What should I tell my health care provider before I take this medicine?

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

• diabetes
• hepatitis
• high cholesterol
• human immunodeficiency virus (HIV) infection
• immune system problems
• infection (especially a virus infection like chickenpox, cold sores, or herpes)
• lung or breathing disease, like asthma
• tuberculosis
• an unusual or allergic reaction to canakinumab, other medicines, polysorbate 80, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

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

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 years for selected conditions, precautions do apply.

Overdosage: If you think you've 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 medicine?

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

• adalimumab
• anakinra
• certolizumab
• etanercept
• golimumab
• infliximab
• rilonacept

This medicine may also interact with the following medications:

• steroid medicines like prednisone or cortisone
• vaccines
• 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 medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Your condition will be monitored carefully while you are receiving this medicine.

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. This medicine may increase your risk of getting an infection. Try to avoid being around people who are sick. Tell your doctor or health care professional if you are around anyone with measles or chickenpox or if you develop sores or blisters that do not heal properly.

You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

What side effects may I notice from receiving this medicine?

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
• feeling faint or lightheaded, falls
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

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

• diarrhea
• dizziness
• headache
• nausea, vomiting
• redness, bruising, itching, stinging, or swelling 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 medicine?

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.