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Medications and Drugs

Brand Names: Ilaris

Generic Name: canakinumab (Pronunciation: KAN a KIN ue mab)

What is canakinumab (Ilaris)?

Canakinumab reduces the effects of a substance in the body that can cause inflammation.

Canakinumab is used to treat rare genetic conditions such as Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children who are at least 4 years old.

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

What are the possible side effects of canakinumab (Ilaris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness;
  • cough with yellow or green mucus;
  • stabbing chest pain, feeling short of breath; or
  • severe dizziness or spinning sensation.

Less serious side effects may include:

  • runny or stuffy nose;
  • diarrhea, mild nausea;
  • headache;
  • joint or muscle pain;
  • mild dizziness; or
  • weight gain.

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.

What is the most important information I should know about canakinumab (Ilaris)?

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

Before using canakinumab, tell your doctor if you have an active infection, a history of recurrent infections, a weak immune system, or a history of tuberculosis.

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

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

Canakinumab can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses.

Serious and sometimes fatal infections may occur during treatment with canakinumab. Contact your doctor right away if you have signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

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



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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