Ilaris Side Effects

Generic name: canakinumab

Note: This document contains side effect information about canakinumab. Some of the dosage forms listed on this page may not apply to the brand name Ilaris.

Some side effects of Ilaris may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to canakinumab: subcutaneous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking canakinumab (the active ingredient contained in Ilaris) 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 of canakinumab 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.

For Healthcare Professionals

Applies to canakinumab: subcutaneous powder for injection

Respiratory

Respiratory side effects including nasopharyngitis (34%), rhinitis (17%), bronchitis (11%), and pharyngitis (11%) have been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (20%), nausea (14%), and gastroenteritis (11%) have been reported.

Other

Other side effects including influenza (17%) and increased weight (11%) have been reported.

Nervous system

Vertigo has been reported in 9% to 14% of patients in CAPS studies, exclusively in Muckle-Wells Syndrome (MWS) patients, and reported as a serious adverse event in two cases. All events resolved with continued treatment with canakinumab (the active ingredient contained in Ilaris)

Nervous system side effects including headache (14%) and vertigo (11%) have been reported.

Musculoskeletal

Musculoskeletal side effects including musculoskeletal pain (11%) have been reported.

Local

Local side effects including subcutaneous injection site reactions have been reported.

No severe injection site reactions were reported and none led to discontinuation of treatment.

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