Pronunciation: KAN a KIN ue mab

Brand: Ilaris

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.

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 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.

What are the possible side effects of canakinumab?

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.

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.

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