Fact sheet - Exjade (deferasirox)

Date: 2006-10-24

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What is EXJADE?

EXJADE is an oral iron chelator supplied as dispersible tablets that contain 125 mg, 250 mg or 500 mg of the active substance deferasirox, and used to remove the excess iron from the body tissues.

Health Canada has approved EXJADE with conditions, under the Notice of Compliance with Conditions policy for the management of chronic iron overload in patients with transfusion-dependent anemias aged six years or older and in patients aged two to five who cannot be adequately treated with deferoxamine. There is limited data available on the use of EXJADE in young children aged 2-5. This authorization reflects the promising nature of the clinical evidence and safety of EXJADE, which must be verified and/or extended with further studies. Products approved under Health Canada's NOC/c policy, have demonstrated promising benefit, are high quality and possess an acceptable safety profile based on a benefit/risk assessment.

What is EXJADE used for?

EXJADE is a once-daily oral iron chelator for the management of chronic iron overload caused by blood transfusions.

What is Iron Chelation Therapy?

Iron chelation therapy is the removal of excess iron from the body (also called iron overload) resulting from repeated blood transfusions. Repeated blood transfusions are necessary in patients suffering from certain types of anemia such as thalassemia, sickle cell disease or myelodysplastic syndromes. However, repeated blood transfusions can cause a build up of excess iron. This is because blood contains iron and your body does not have a natural way to remove the excess iron you get with your blood transfusions. Over time, the excess iron can damage important organs such as the liver and heart.

How does EXJADE work?

Medicines called iron chelators are used in patients with iron overload to remove excess iron and reduce its accumulation leading to organ damage. EXJADE traps and removes excess iron which is then eliminated mainly in the stools.

What are advantages of EXJADE over other therapies?

Desferal (deferoxamine) is the current standard of care in iron chelation. EXJADE will provide a benefit over injectable Desferal because it is an oral therapy.

Who can be treated with EXJADE?

Adults, adolescents, and children aged 6 years and over; and children aged 2 to 5 years who cannot be adequately treated with deferoxamine.

What do patients need to know about using EXJADE?

BEFORE you use EXJADE talk to your doctor or pharmacist if you have any of the following: a liver or kidney problem; a severe inherited intolerance to milk sugars (e.g. lactose); visual (eye) problems; hearing problems or severe heart problems (acute cardiac failure).

Tell your doctor or pharmacist if you are taking other iron chelation therapies, as the safety and efficacy of a combination with EXJADE has not been established.

You will have some blood tests while taking EXJADE. Your doctor will look for any changes in kidney function and liver function. Your doctor will test your eyesight and hearing while you are taking EXJADE.

The growth and development for children and adolescents (from 2 to 16 years of age) will be monitored periodically during treatment with EXJADE as a precautionary measure.

EXJADE should not be used during pregnancy. If you are pregnant or think you may be, tell your doctor.

Breast-feeding is not recommended during treatment with EXJADE. Tell your doctor or pharmacist if you are breast-feeding.

If you feel dizzy after taking EXJADE, do not drive or operate any tools or machines until you are feeling normal again.

What are the side effects and how serious are they?

Like all medicines, EXJADE can have side effects. Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment. Some side effects are common such as gastrointestinal disorders (nausea, vomiting, diarrhea, pain in the abdomen, bloating, constipation, indigestion), rash and headache. Other side effects are uncommon such as dizziness, fever, sore throat, swelling of arms or legs, change in the colour of the skin, anxiety, sleep disorder and tiredness.

Although not common, serious side effects may include changes in kidney function or liver function, severe rash, blurred or cloudy vision and hearing loss or disturbance. Talk to your doctor or pharmacist if you experience any of these serious side effects.

If you notice any other side effects while taking EXJADE, please contact your doctor or pharmacist.

How is EXJADE taken?

Always take EXJADE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

Dose:

• The recommended initial daily dose of EXJADE is 10, 20, or 30 mg/kg/day body weight, depending on your transfusion rate and the goal of treatment.
  
  
• Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose.
  
  
• The maximum recommended daily dose is 30 mg per kilogram body weight.

How to take it:

• Drop the tablet(s) into a glass of water, orange or apple juice.
• Stir until the tablet(s) dissolve completely. The liquid in the glass will look cloudy.
• Drink everything in the glass. Then add a little water or juice to what is left in the glass and drink that too.

EXJADE tablets should be completely dispersed by stirring in water, orange juice or apple juice. Doses < 1 g should be dispersed in 100 mL of liquid. Doses of > 1 g should be dispersed in 200 mL of liquid.

Do not dissolve the tablets in fizzy drinks or milk.

Do not chew, break or crush the tablets. Do not swallow the tablets whole.

When to take EXJADE:

Take EXJADE once a day on an empty stomach at least 30 minutes before eating the first meal of the day, preferably at the same time each day.

What else should patients know about taking EXJADE?

You should not take EXJADE if you are allergic (hypersensitive) to deferasirox or any of the other ingredients of EXJADE. If you are lactose-intolerant, talk to your doctor or pharmacist.

Where can I learn more about EXJADE?

If you have any questions concerning EXJADE, kindly contact our Medical Information Department at 1-800-363-8883.

Please consult your doctor with any questions or concerns you may have regarding your individual condition.

This document including the EXJADE Prescribing Information and Patient Information can be found on our Website (http://www.novartis.ca).

^PrEXJADE* is a registered trademark.