Thursday, March 8, 2012

canakinumab


Generic Name: canakinumab (KAN a KIN ue mab)

Brand Names: 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 other purposes not listed in this medication guide.


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


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

Before using canakinumab, tell your doctor if you have an active infection, a history of recurrent infections, a weak immune system, or a history of tuberculosis.


Your doctor may perform tests to make sure you do not have tuberculosis or other infections.


Make sure you are current on all vaccines before you start treatment with canakinumab.


Canakinumab can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses.


Serious and sometimes fatal infections may occur during treatment with canakinumab. Contact your doctor right away if you have 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.

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


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


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

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:



  • an active infection;




  • a history of recurrent infections;




  • a weak immune system; or




  • a history of tuberculosis.




FDA pregnancy category C. It is not known whether canakinumab is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether canakinumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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


How should I use canakinumab?


Use this medication 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 canakinumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.


Canakinumab is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. Canakinumab 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 canakinumab 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 canakinumab 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 this medicine 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.


Canakinumab 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 vial in its original carton to protect the medicine from light. Mixed medication may be stored in a refrigerator and used within 4 hours.

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?


Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a canakinumab overdose are not known.


What should I avoid while using canakinumab?


Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.


Do not receive a "live" vaccine while you are being treated with canakinumab. The live vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Make sure you are current on all vaccines before you begin treatment with canakinumab.


Canakinumab side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • 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, unusual weakness;




  • cough with yellow or green mucus;




  • stabbing chest pain, feeling short of breath; or




  • severe dizziness or spinning sensation.



Less serious side effects may include:



  • runny or stuffy nose;




  • diarrhea, mild nausea;




  • headache;




  • joint or muscle pain;




  • mild dizziness; or




  • weight gain.



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.


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.


What other drugs will affect canakinumab?


Tell your doctor about all other medications you use, especially:



  • adalimumab (Humira);




  • certolizumab (Cimzia);




  • cyclosporine (Gengraf, Neoral, Sandimmune);




  • digoxin (digitalis, Lanoxin, Lanoxicaps);




  • etanercept (Enbrel);




  • golimumab (Simponi);




  • infliximab (Remicade);




  • a blood thinner such as warfarin (Coumadin);




  • sirolimus (Rapamune) or tacrolimus (Prograf);




  • theophylline (Elixophyllin, Theo-24, Uniphyl);




  • seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene); or




  • a heart rhythm medication such as disopyramide (Norpace), procainamide (Procan, Pronestyl), or quinidine (Quinidex, Quin-Release Quin-G).



This list is not complete and there may be other drugs that can interact with canakinumab. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More canakinumab resources


  • Canakinumab Side Effects (in more detail)
  • Canakinumab Use in Pregnancy & Breastfeeding
  • Canakinumab Drug Interactions
  • Canakinumab Support Group
  • 0 Reviews for Canakinumab - Add your own review/rating


  • canakinumab Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Canakinumab Professional Patient Advice (Wolters Kluwer)

  • Canakinumab MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ilaris Prescribing Information (FDA)

  • Ilaris Consumer Overview



Compare canakinumab with other medications


  • Cryopyrin-Associated Periodic Syndromes
  • Familial Cold Autoinflammatory Syndrome
  • Muckle Wells Syndrome


Where can I get more information?


  • Your doctor or pharmacist can provide more information about canakinumab.

See also: canakinumab side effects (in more detail)


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