For Healthcare Professionals
EXJADE® (deferasirox) Tablets for Oral Suspension is not indicated for the treatment of thalassemia and rare anemias such as aplastic anemia and Diamond-Blackfan syndrome.
EXJADE® (deferasirox) Tablets for Oral Suspension is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Further studies are being performed to determine the long-term benefits and risks of EXJADE.
People with thalassemia and rare anemias such as aplastic anemia and Diamond-Blackfan syndrome and other anemias may require frequent blood transfusions. If you have received multiple blood transfusions, you may be at risk for a condition called chronic iron overload.
This site will help you to learn more about EXJADE, and how it can treat chronic iron overload due to blood transfusions.
Each unit of red blood cells contains many more times the amount of iron your body can get rid of naturally. With multiple transfusions, this buildup of excess iron may lead to chronic iron overload.
As in adults, excess iron can also build up over time in younger people receiving blood transfusions.
So if you or someone you care about has had blood transfusions, you should keep track of them.
Knowing your numbers means knowing how many transfused units you have received. It is important to keep track of your past and present transfused units. If you think you may have had close to or more than 20 transfused units in your lifetime, you should ask your doctor about chronic iron overload. Your doctor can give you a simple blood test (called a serum ferritin test) that measures iron levels.
After 20 transfused units, you may have chronic iron overload, even if it has been years between transfusions.
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EXJADE is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years and older.
Further studies are being performed to determine the long-term benefits and risks of EXJADE.
People who are allergic to EXJADE or any ingredient of EXJADE should not take EXJADE.
Before you start EXJADE, your doctor will give you blood tests, because EXJADE may affect your kidneys, liver, or blood. The blood tests will be performed every month to check your kidney and liver function, your serum ferritin levels, and your blood count. If you are at increased risk of complications because you have a pre-existing kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your kidneys, your doctor will give you a blood test every week for the first month you are taking EXJADE or if your dose has changed, and then every month after that. Your doctor may also collect urine samples monthly.
Some patients developed severe kidney problems, in some cases fatal, while on EXJADE. Most of the fatalities occurred in patients who were very ill because of their disease. There may be increased risk of complications for patients who already have a kidney condition, are elderly, have multiple medical conditions, or take medicine that affects kidney function.
Some patients developed severe liver problems, in some cases fatal, while on EXJADE. Many of these patients were greater than 55 years of age and/or had multiple medical conditions already affecting their liver.
Some patients developed blood disorders, in some cases fatal, while on EXJADE therapy, but it is not known whether this was a result of EXJADE therapy or other causes, as most of these patients already had diseases affecting their blood.
Serious allergic reactions (which include swelling of the throat) have been reported in patients taking EXJADE, usually within the first month of treatment. If reactions are severe, stop taking EXJADE and contact your doctor immediately.
You may also receive a hearing or vision test prior to receiving EXJADE and yearly thereafter. Your dose of EXJADE may be changed if needed based on the results of these tests.
Should you develop swelling of the throat, a severe rash, or any hearing problems or vision disturbances, please contact your doctor.
EXJADE should be taken once daily on an empty stomach, at least 30 minutes prior to food, preferably at the same time every day.
EXJADE should not be chewed or swallowed whole, and should not be taken at the same time as aluminum-containing antacids (for example, Maalox®).
The most commonly reported side effects related to EXJADE in clinical trials were mainly nausea, vomiting, diarrhea, stomach pain, fever, cough, headache, increases in kidney lab values, and skin rash. These side effects were mild to moderate in severity. If you experience diarrhea or vomiting you should ensure that you continue to drink fluids.
Please see the full prescribing information.
