EXJADE is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years and older. In these patients, EXJADE has been shown to reduce liver iron concentration and serum ferritin levels. Clinical trials to demonstrate increased survival or to confirm clinical benefit have not been completed.
Talk to your doctor to determine if EXJADE therapy is right for you. The expected benefit and risks of the therapy, as well as factors such as life expectancy and other illnesses should be considered.
The safety and efficacy of EXJADE when taken with other iron chelation therapy have not been proven.
Further studies are being performed to determine the long-term benefits and risks of EXJADE.
EXJADE is available by prescription only.

Important Safety Information

Certain people should not take EXJADE, including:

• People with certain kinds of kidney problems
• People with high-risk myelodysplastic syndromes or cancers
• People with low blood counts (low platelets)
• People who are allergic to EXJADE or any ingredient of EXJADE

Kidneys: 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 while on EXJADE, in some cases fatal, and in some cases requiring dialysis. 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.

Liver: People with pre-existing severe liver problems should not use EXJADE. A lower starting dose of 10 mg/kg/day is recommended for people with moderate liver problems. Anyone using EXJADE who has mild or moderate liver problems should be closely monitored. They may need their dose adjusted based on efficacy or safety.

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. Your doctor will give you blood tests called serum transaminases and bilirubin before starting treatment, every 2 weeks during the first month of treatment, and then monthly.

Stomach: Some patients developed stomach irritation or bleeds while on EXJADE. In some cases, stomach bleeds were fatal, usually in patients who were elderly and had pre-existing blood cancers and/or low blood counts (low platelets). 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).

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.

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.

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

Rash: A skin disorder that results in a very serious rash, called erythema multiforme, has been reported during treatment with EXJADE.

Comorbidities: Since EXJADE has been on the market, there have been reports of some serious reactions, sometimes leading to death. These serious reactions happened most often when EXJADE was taken by elderly patients, those with multiple medical conditions, or those with advanced diseases. Most of these deaths happened within 6 months of starting EXJADE, and the original disease usually got worse. The reports do not rule out the possibility that EXJADE may have contributed to the deaths.

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.

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.

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.