Important Safety Information

EXJADE is available by prescription only.

There have been reports of serious kidney problems, liver problems, and blood disorders, some of which were fatal, in patients treated with EXJADE. There have also been reports of stomach irritation and bleeds, skin rash, hearing problems and vision disturbances, and serious allergic reactions.

Your doctor will conduct periodic blood and urine tests to monitor your kidney and liver function and blood health. You should also have annual eye and ear examinations. These tests are important because any serious reactions should be addressed in a timely manner. Alert your doctor if you are taking any NSAIDs, corticosteroids, or other medicines with potential to cause ulcers or stomach bleeding. If you have any reactions to EXJADE, speak with your doctor immediately.

Please see additional Important Safety Information.
Please see accompanying Full Prescribing Information.

and understand how it might help you reduce excess iron levels from blood transfusions.
Having 10 or more transfusions (or 20 transfused units of blood) can put you at risk for chronic iron overload due to blood transfusions. Find out if you are at risk and when you might need treatment with EXJADE.
 
 

EXJADE 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.

EXJADE is available by prescription only.

Important Safety Information About 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, your serum ferritin levels, and your blood count. To test your liver function, your doctor will also test your blood every 2 weeks during your first month of treatment, and then monthly after that.

Kidney: 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.

Blood Disorders: 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.

Liver: 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.

Allergic Reactions: 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.

Stomach: Some patients developed stomach irritation or bleeds while on EXJADE. Talk to your doctor if you are taking other drugs which can also irritate your stomach or cause a stomach bleed (e.g. NSAIDs, corticosteroids, oral bisphosphonates, blood thinners).

Hearing and Vision Tests: 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.

Serious Reactions: Should you develop swelling of the throat, a severe rash, or any hearing problems or vision disturbances, please contact your doctor immediately.

How to Take EXJADE: 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®).

Other Medicines and EXJADE: If you are taking other medicines, such as birth control pills, diabetes drugs, seizure drugs, cholesterol lowering drugs, or medicine for serious illnesses, talk to your doctor. EXJADE may affect how these drugs work.

Common Side Effects: The most commonly reported side effects related to EXJADE in clinical trials were mainly nausea, vomiting, diarrhea, stomach pain, 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.

*Maalox is a registered trademark of Novartis Consumer Health, Inc.

Full Prescribing Information

The prescribing information includes detailed information on how EXJADE works, clinical studies, risks/side effects, drug interactions, and dosing for patients.

Read the full prescribing information for EXJADE® (deferasirox) Tablets for Oral Suspension.