Canakinumab

Canakinumab is a prescription medication used to treat rare genetic auto-inflammatory diseases known as Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). Canakinumab is also approved to treat active systemic juvenile idiopathic arthritis (JIA) in patients aged 2 years and older.

Canakinumab belongs to a group of drugs called interleukin-1 beta blockers, which block a protein responsible for inflammation.

This medication comes in an injectable form to be injected just under the skin by your doctor or healthcare provider every 8 weeks.

Common side effects of canakinumab include cold symptoms, diarrhea, runny nose, and headache.

Canakinumab is a prescription medicine injected just below the skin (subcutaneous) used in adults and children 4 years and older to treat auto-inflammatory diseases known as Cryopyrin-Associated Periodic Syndromes (CAPS), including:

• Familial Cold Autoinflammatory Syndrome (FCAS) 
• Muckle-Wells Syndrome (MWS)

Canakinumab is also approved to treat active systemic juvenile idiopathic arthritis (JIA) in patients aged 2 years and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Canakinumab may be found in some form under the following brand names:

• Ilaris

The most common side effects include:

• cold symptoms 
• diarrhea 
• flu (influenza) 
• runny nose 
• nausea 
• headache 
• injection site reaction (such as redness, swelling, warmth, itching)
• feeling like you are spinning (vertigo)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Canakinumab can cause serious side effects. See "Drug Precautions" section.

These are not all the possible side effects of canakinumab. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take:

• Medicines that affect your immune system 
• IL-1 blocking agents such as Kineret (anakinra), Arcalyst (rilonacept) 
• Tumor Necrosis Factor (TNF) inhibitors such as Enbrel (etanercept) 
• Humira (adalimumab), or Remicade (infliximab) 
• Medicines that can affect enzyme metabolism. Ask your healthcare provider if you are not sure.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

Canakinumab can cause serious side effects including:

• serious infections. Symptoms of an infection may include:
  • a fever lasting longer than 3 days
  • a cough that does not go away
  • redness in one part of your body
  • warm feeling or swelling of your skin

• decrease your body’s ability to fight infections (immunosuppression)

Other serious side effects may occur while you are taking and after you finish taking canakinumab including allergic reactions.

Symptoms of an allergic reaction may include:

• rash (hives)
• swollen face
• problems breathing or swallowing

Call your healthcare provider right away or get emergency medical help if you have any of the signs of an infection or allergic reaction.

Do not take canakinumab if you are allergic to canakinumab or any of the ingredients in canakinumab. 

Before you take canakinumab, tell your healthcare provider if you:

• think you have an infection 
• are being treated for an infection 
• have signs of an infection, such as fever, cough, or flu-like symptoms 
• have a history of infections that keep coming back
• have or have had HIV, Hepatitis B, or Hepatitis C
• have an immune system problem. People with these conditions have a higher chance for infections. 
• have tuberculosis (TB), or if you have been in close contact with someone who has or has had tuberculosis 
• are scheduled to receive any immunizations (vaccines). You should not get ‘live vaccines’ if you take canakinumab. 
• are pregnant or planning to become pregnant. It is not known if canakinumab will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking canakinumab. 
• are breastfeeding or planning to breastfeed. It is not known if canakinumab passes into your breast milk. You and your healthcare provider should decide if you will take canakinumab or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. It is not known if canakinumab passes into your breast milk. You and your healthcare provider should decide if you will take canakinumab or breastfeed. You should not do both.

• Canakinumab comes in the form of an injection to be given just under the skin (subcutaneously).
• Canakinumab is usually given by a healthcare provider once every 8 weeks.
• Do not receive canakinumab if you have an infection. 

Dosage for the treatment of CAPS

The recommended dose of canakinumab for the treatment of cryopyrin-associated periodic syndromes (CAPS) in people who weigh more than 40 kg (88 pounds) is 150 mg every eight weeks.

If canakinumab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.