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canakinumab

Generic Name: canakinumab (KAN a KIN ue mab)
Brand Name: Ilaris

What is canakinumab?

Canakinumab reduces the effects of a substance in the body that can cause inflammation.

Canakinumab is used to treat rare genetic conditions such as Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children who are at least 4 years old.

Canakinumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about canakinumab?

Canakinumab can lower blood cells that help your body fight infections. Serious and sometimes fatal infections may occur during treatment with canakinumab. Call your doctor right away if you have signs of infection such as: flu symptoms, cough, shortness of breath, weight loss, redness or swelling under your skin, or fever lasting 3 days or longer.

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What should I discuss with my health care provider before receiving canakinumab?

You should not use this medicine if you are allergic to canakinumab.

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 you begin treatment with canakinumab.

To make sure canakinumab is safe for you, tell your doctor if you have:

  • an active infection;

  • a history of low white blood cell counts;

  • a weak immune system;

  • a history of HIV, hepatitis B, or hepatitis C;

  • a history of recurrent infections; or

  • if you are scheduled to receive any vaccine.

FDA pregnancy category C. It is not known whether canakinumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether canakinumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Treatment with canakinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.

How should I use canakinumab?

Before you start treatment with canakinumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Canakinumab is injected under the skin. A healthcare provider will give you this injection.

Canakinumab is usually given once every 8 weeks. Follow your doctor's instructions.

Canakinumab can weaken your immune system. Your blood may need to be tested often.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medicine.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while using canakinumab?

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.

Canakinumab side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; dizziness, nausea; fast or pounding heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Canakinumab can lower blood cells that help your body fight infections. Serious and sometimes fatal infections may occur during treatment with canakinumab. Call your doctor right away if you have signs of infection such as:

  • fever for 3 days or longer;

  • cough, shortness of breath;

  • warmth, redness, or swelling under your skin; or

  • flu symptoms, weight loss.

Call your doctor at once if you have a side effect such as:

  • swollen gums, painful mouth sores, pain when swallowing;

  • skin sores; or

  • pain, swelling, redness, warmth, blistering, or bleeding where an injection was given.

Common side effects may include:

  • itching, bruising, or minor irritation where the injection was given.

  • nausea, diarrhea;

  • headache, dizziness, spinning sensation; or

  • runny or stuffy nose, sinus pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Canakinumab dosing information

Usual Adult Dose for Cryopyrin-Associated Periodic Syndrome:

Body weight greater than 40 kg
Recommended dose: 150 mg as a single dose via subcutaneous injection

Body weight between 15 kg and 40 kg
Recommended dose: 2 mg/kg as a single dose via subcutaneous injection

Canakinumab is administered every eight weeks.

Usual Pediatric Dose for Cryopyrin-Associated Periodic Syndrome:

Body weight greater than 40 kg
Recommended dose: 150 mg as a single dose via subcutaneous injection

Body weight between 15 kg and 40 kg
Recommended dose: 2 mg/kg as a single dose via subcutaneous injection

For children 15 to 40 kg with an inadequate response, the dose can be increased to 3 mg/kg as a single dose via subcutaneous injection.

Canakinumab is administered every eight weeks.

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

4 mg/kg subcutaneously every four weeks

Maximum dose: 300 mg

Comments: Approved dosing is only for body weight greater than 7.5 kg.

What other drugs will affect canakinumab?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with canakinumab, especially:

  • adalimumab;

  • anakinra;

  • infliximab;

  • rilonacept; or

  • other drugs that weaken immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with canakinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about canakinumab.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2013-04-16, 3:14:17 PM.

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