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

What is Ilaris?

Ilaris (canakinumab) reduces the effects of a substance in the body that can cause inflammation.

Ilaris is used to treat rare genetic Periodic Fever Syndromes including Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), and Familial Mediterranean Fever (FMF) in adult and pediatric patients.

Ilaris is also used to treat active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.

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

Important information

Ilaris can lower blood cells that help your body fight infections. Serious and sometimes fatal infections may occur during treatment with Ilaris. 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.

Before receiving Ilaris

You should not use Ilaris 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 Ilaris.

To make sure Ilaris 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 Ilaris will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

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 Ilaris may increase your risk of developing cancer. Talk to your doctor about your individual risk.

How should I use Ilaris?

Use Ilaris exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

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

Ilaris is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. Ilaris is usually given once every 8 weeks. Follow your doctor's instructions.

You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

You will need to mix Ilaris with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Do not shake the medication vial (bottle) after mixing. Vigorous shaking can ruin the medicine. Do not draw your Ilaris dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

After mixing your medicine, protect it from light and use it within 1 hour.

Each single-use vial (bottle) of Ilaris is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Ilaris can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

Store the powder medicine in the refrigerator and do not freeze. Keep the Ilaris vial in its original carton to protect the medicine from light. Mixed medication may be stored in a refrigerator and used within 4 hours.

See also: Dosage Information (in more detail)

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?

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 Ilaris. 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.

Ilaris side effects

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

Ilaris can lower blood cells that help your body fight infections. Serious and sometimes fatal infections may occur during treatment with Ilaris. 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 Ilaris 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)

What other drugs will affect Ilaris?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Ilaris, 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 Ilaris, 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 Ilaris.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ilaris 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 1996-2016 Cerner Multum, Inc. Version: 2.01. Revision Date: 2013-04-16, 3:14:17 PM.