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

Applies to canakinumab: subcutaneous solution.

Serious side effects of Ilaris

Along with its needed effects, canakinumab (the active ingredient contained in Ilaris) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking canakinumab:

More common

• Body aches or pain
• chills
• cough
• diarrhea
• dryness or soreness of the throat
• fever
• headache
• hoarseness
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• shivering
• sneezing
• stomach pain
• stuffy or runny nose
• sweating
• tender, swollen glands in the neck
• tightness in the chest
• trouble breathing or swallowing
• trouble sleeping
• unusual tiredness or weakness
• voice changes
• vomiting

Incidence not known

• Chest pain
• lightheadedness or dizziness
• skin rash, itching
• swelling of the face, tongue, and throat

Other side effects of Ilaris

Some side effects of canakinumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• feeling of constant movement of self or surroundings
• increased weight
• muscle or bone pain
• sensation of spinning
• weakness

For Healthcare Professionals

Applies to canakinumab: subcutaneous powder for injection, subcutaneous solution.

Gastrointestinal

Very common (10% or more): Diarrhea (20%), nausea (14%), gastroenteritis, tonsillitis, upper abdominal pain, gastroesophageal reflux disease^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection^[Ref]

Hematologic

Very common (10% or more): Leukopenia

Frequency not reported: Hemoglobin increased, decreased white blood cells, decreased neutrophils, decreased platelets^[Ref]

Hepatic

Rare (less than 0.1%): Elevated transaminases

Frequency not reported: Elevated serum bilirubin^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (unspecified)^[Ref]

Immunologic

Very common (10% or more): Influenza (17%), viral infection (13%)^[Ref]

Local

Very common (10% or more): Injection site reaction^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (11%), arthralgia

Common (1% to 10%): Back pain^[Ref]

Nervous system

Very common (10% or more): Headache (14%), dizziness/vertigo (11%)^[Ref]

Other

Very common (10% or more): Ear infection

Common (1% to 10%): Fatigue/asthenia^[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (34%), rhinitis (17%), bronchitis (11%), pneumonia, sinusitis, rhinitis, pharyngitis, upper respiratory tract infection^[Ref]

Dermatologic

Very common (10% or more): Cellulitis^[Ref]

Metabolic

Very common (10% or more): Weight gain (11%)^[Ref]

Renal

Very common (10% or more): Creatinine clearance decreased, proteinuria^[Ref]