Canakinumab

Canakinumab is a prescription medication used to treat periodic fever syndromes, sometimes called auto-inflammatory syndromes. Canakinumab is used to treat the following rare 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 at least 2 years old.

• Canakinumab is available under various brand names: Ilaris

Common side effects of Canakinumab include:

• cold or flu symptoms (runny nose, cough, sore throat, body aches).
• nausea, vomiting, diarrhea, and stomach pain.
• painful urination.
• dizziness, spinning sensation.
• headache.
• weight gain; or
• itching, redness, swelling, or warmth where the medicine was injected.

Serious side effects of Canakinumab include:

• hives. 
• nausea, 
• trouble swallowing. 
• dizziness,
• fast or pounding heartbeats, 
• difficulty breathing. 
• swelling of the face, lips, tongue, or throat.
• fever lasting longer than 3 days, chills, sweating.
• sores, warmth, or pain anywhere on the body.
• stomach pain, diarrhea, and weight loss.
• ongoing cough, and 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 the skin; or
• flu symptoms and feeling very tired.

Rare side effects of Canakinumab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Severe eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Severe heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Powder for injection

• 180 mg/vial (150 mg/mL after reconstitution)

Cryopyrin-Associated Periodic Syndrome

Adult dosage

• Above 40 kg: 150 mg Subcutaneous every 8 weeks
• 15-40 kg: 2 mg/kg Subcutaneous every 8weeks; may increase to 3 mg/kg if inadequate response  

Pediatric dosage

• Children below 4 years
  • Safety and efficacy not established
• Children above 4 Years
  • 15-40 kg: 2 mg/kg Subcutaneous 8 weeks  
  • Above 40 kg: 150 mg Subcutaneous every 8 weeks

Tumor Necrosis Factor Receptor-Associated Periodic Syndrome

Adult dosage

• 150 mg subcutaneous every 4 weeks; may increase to 300 mg every 4 weeks if the clinical response is not adequate

Pediatric dosage

• Children below 40 kg: 2 mg/kg subcutaneous every 4 weeks; may increase to 4 mg/kg every 4 weeks if the clinical response is not adequate  
• For children above 40 kg: 150 mg Subcutaneous every 4 weeks; may increase to 300 mg every 4 weeks if the clinical response is not adequate

Hyper immunoglobulin D Syndrome/Mevalonate Kinase Deficiency

Adult dosage

• 150 mg subcutaneous every 4 weeks; may increase to 300 mg every 4 weeks if the clinical response is not adequate

Pediatric dosage

• Children Below 40 kg: 2 mg/kg subcutaneous every 4 weeks; may increase to 4 mg/kg every 4 weeks if the clinical response is not adequate  
• Children above 40 kg: 150 mg subcutaneous every 4 weeks; may increase to 300 mg every 4 weeks if the clinical response is not adequate

Familial Mediterranean Fever

Adult dosage

• 150 mg subcutaneous 4 weeks; may increase to 300 mg every 4 weeks if the clinical response is not adequate

Pediatric dosage

• Below 40 kg: 2 mg/kg subcutaneous 4 weeks; may increase to 4 mg/kg every 4 weeks if the clinical response is not adequate  
• Above 40 kg: 150 mg subcutaneous 4 weeks; may increase to 300 mg every 4 weeks if the clinical response is not adequate

Still’s Disease

Adult dosage

• Indicated for the treatment of active Still’s disease, including adult-onset Still’s a disease (AOSD)
• 4 mg/kg subcutaneous every 4 weeks; not to exceed 300 mg/dose

Pediatric dosage

• Children below 2 years: Safety and efficacy not established
• Children above 2 years and weight above 7.5 kg: 4 mg/kg Subcutaneous 4 weeks; not to exceed 300 mg/dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Canakinumab has severe interactions with the following drugs:
  • upadacitinib
• Canakinumab has serious interactions with at least 69 other drugs.
• Canakinumab has moderate interactions with at least 21 other drugs.
• Canakinumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to canakinumab.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Canakinumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Canakinumab?”

Cautions

• Severe and sometimes fatal infections may occur during treatment with canakinumab. Call your doctor immediately 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.
• 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.
• Make sure you are current on all vaccines before starting canakinumab treatment.
• Treatment with canakinumab may increase your risk of developing cancer. Talk to your doctor about your risk.
• 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.

Pregnancy and Lactation

• 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 Canakinumab during pregnancy. Being exposed to canakinumab in the womb could affect your baby's vaccination schedule during the first 12 months of life.

Lactation

• It may not be safe to breastfeed while using this Canakinumab. Ask your doctor about any risks.