For Healthcare Professionals
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.
