Canakinumab is a monoclonal antibody that blocks certain proteins in the body that can affect inflammation and other immune responses. Canakinumab is used to treat certain types of periodic fever syndromes, sometimes called auto-inflammatory syndromes.

Periodic fever syndromes are rare and often inherited conditions caused by mutations in certain genes; usually genes that are involved in producing a certain protein or enzyme in the body. People with a periodic fever syndrome have episodes of fever and inflammation without other causes such as infection or virus.

Canakinumab is used to treat the following periodic fever syndromes in adults and children who are at least 4 years old:

• Cryopyrin-Associated Periodic Syndromes, including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome

• Tumor Necrosis Factor Receptor Associated Periodic Syndrome

• Hyperimmunoglobulin D Syndrome, also called Mevalonate Kinase Deficiency

• Familial Mediterranean Fever

Canakinumab is also used to treat Still's disease including Adult-Onset Still's Disease and Systemic Juvenile Idiopathic Arthritis in children who are at least 2 years old.

Canakinumab may also be used for purposes not listed in this medication guide.

Serious and sometimes fatal infections may occur during treatment with canakinumab. Call your doctor right away if you have signs of infection such as: fever, chills, sweating, tiredness, cough, shortness of breath, skin sores, warm or painful areas on your body, diarrhea, stomach pain, or weight loss.

Before you start treatment with canakinumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Canakinumab is injected under the skin. A healthcare provider will give you this injection.

Canakinumab is usually given once every 4 to 8 weeks depending on the condition being treated. Follow your doctor's instructions.

Tell your doctor if you have any changes in weight. Canakinumab doses are based on weight (especially in children and teenagers), and any changes may affect the dose.

Canakinumab can weaken your immune system. Your blood may need to be tested often.

You should not use canakinumab if you are allergic to canakinumab.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Tell your doctor if you have ever had:

• an active or chronic infection;

• low white blood cell counts;

• a weak immune system;

• HIV, hepatitis B, or hepatitis C;

• a history of recurrent infections; or

• if you have recently received or are scheduled to receive any vaccine.

Make sure you are current on all vaccines before you begin treatment with canakinumab.

Treatment with canakinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.

Tell your doctor if you are pregnant or plan to become pregnant.

If you use canakinumab while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to canakinumab in the womb could affect your baby's vaccination schedule during the first 12 months of life.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Call your doctor for instructions if you miss an appointment for your canakinumab injection.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using canakinumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Get emergency medical help if you have signs of an allergic reaction: hives; nausea, trouble swallowing; dizziness, fast or pounding heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with canakinumab. Call your doctor right away if you have signs of infection such as:

• fever lasting longer than 3 days, chills, sweating;

• sores, warmth, or pain anywhere on your body;

• stomach pain, diarrhea, weight loss;

• ongoing cough, shortness of breath;

• chest pain, coughing up mucus or blood;

• pain or burning when you urinate;

• redness in one part of your body;

• warmth, redness, or swelling under your skin; or

• flu symptoms, feeling very tired.

Common side effects of canakinumab may include:

• cold or flu symptoms (runny nose, cough, sore throat, body aches);

• nausea, vomiting, diarrhea, stomach pain;

• painful urination;

• dizziness, spinning sensation;

• headache;

• weight gain; or

• itching, redness, swelling, or warmth where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• anakinra;

• adalimumab, certolizumab, golimumab, infliximab;

• etanercept, rilonacept;

• warfarin; or

• other drugs that weaken immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may affect canakinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.