CANAKINUMAB

Check with your doctor or nurse immediately if any of the following side effects occur.

Do not use this drug if:

• You are Allergic to any Ingredient in Canakinumab
• You are Using Another Interleukin-1 Blocker (Eg, Anakinra, Rilonacept), Tocilizumab, Tofacitinib, or a Tumor Necrosis Factor (TNF) Blocker (Eg, Adalimumab, Etanercept, Infliximab)
• You Will be Receiving a Live Vaccine
• You Have a Severe Infection (Eg, Sepsis), HIV, Hepatitis B Or C, or Any Other Active Infection

If any of these apply to you, contact your doctor or health care provider right away.

More common side effects are:

• Body Aches or Pain
• Chills
• Congestion
• Cough
• Diarrhea
• Dryness or Soreness of the Throat
• Fever
• Headache
• Hoarseness
• Joint Pain
• Loss of Appetite
• Muscle Aches and Pains
• Nausea
• Shivering
• Shortness of Breath
• Sneezing
• Stuffy or Runny Nose
• Sweating
• Tender, Swollen Glands in the Neck
• Tightness in the Chest
• Trouble Sleeping
• Trouble Swallowing
• Unusual Tiredness or Weakness
• Voice Changes
• Vomiting

Other symptoms may include:

• Abdominal or Stomach Pain
• Increased Weight
• Muscle or Bone Pain
• Sensation of Spinning
• Weakness

Precautions

Some medical conditions may interact with canakinumab.

Before using canakinumab, tell your doctor or pharmacist if you have any medical conditions, especially if:

• You are Pregnant, Planning to Become Pregnant, or are Breast-Feeding
• You are Taking Any Prescription or Nonprescription Medicine, Herbal Preparation, or Dietary Supplement
• You Have Allergies to Medicines, Foods, or Other Substances, Including Rubber
• You Have a History of an Infection That Keeps Coming Back,  Tuberculosis (Tb) Infection Or Positive Tb Skin Test, Hepatitis B Infection, Low White Blood Cell Counts, Low Blood Platelet Levels, or Cancer
• You Have An Autoimmune Disorder (Eg, Lupus) Or Other Immune System Problems, Have Recently Received A Vaccine, Are Scheduled To Receive A Vaccine, Or Are Scheduled To Have Surgery
• You Have Open Cuts or Sores On Your Body or Flu-Like Symptoms or Other Signs of Infection (Eg, Fever, Chills, Cough, Warm, Red, or Painful Skin), or if You are Using Medicine to Treat an Infection
• You Have Ever Lived in or Travelled to an Area Where TB is Common, or if You Have Come Into Close Contact with a Person with Active TB
• You Take Medicine That May Decrease Your Immune System (eg, Cyclosporine)

Interactions

To avoid drug interactions, tell your health care provider if you are taking any other medicines, especially any of the following:

• Another Interleukin-1 Blocker (Eg, Anakinra, Rilonacept), Tocilizumab, Tofacitinib, or a Tumor Necrosis Factor (TNF) Blocker (Eg, Adalimumab, Etanercept, Infliximab)

–The Risk of Serious Infection May be Increased

• Warfarin

-The Risk Of Its Side Effects May Be Increased By Canakinumab

Ask your health care provider if canakinumab may interact with other medicines that you are taking or planning to take. Do not start, stop, or change the dose of any medicine without consulting your doctor or healthcare provider.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call emergency hotline.