Important Safety Information

EXJADE is available by prescription only.

What is the most important safety information to know about EXJADE?

EXJADE may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines. In some cases, these problems were fatal.

These problems occurred more often in elderly patients, patients with high-risk myelodysplastic syndromes, pre-existing kidney or liver problems, or low blood counts.

EXJADE may also cause serious liver problems. In some cases, these problems were fatal. These problems occurred more often in patients greater than 55 years of age.

Your doctor should check your kidneys with a blood test called serum creatinine and/or creatinine clearance:

  • Before taking EXJADE
  • Monthly during treatment

If you already have kidney problems or are at risk for kidney problems your doctor should check your kidneys:

  • Every week for the first month
  • Monthly during treatment

Your doctor should check your liver with blood tests called serum transaminases and bilirubin:

  • Before taking EXJADE
  • Every other week for the first month after starting EXJADE
  • Monthly during treatment

Please see additional Important Safety Information, including Boxed WARNING.

Please see accompanying Full Prescribing Information.

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How Much Iron Could EXJADE Remove?

Therapy with EXJADE may be considered in a person who has:

  • 10 or more blood transfusions (or 20 transfused units of blood) that have   left too much iron in his or her body

  • Iron (or serum ferritin) levels that are consistently higher than 1000 mcg/L   (micrograms per liter)

To understand the change in iron levels in your body, you must know the amount of iron already in your body that you are receiving through blood transfusions and the amount of iron EXJADE is removing.

Each bag (unit) of blood contains 200 milligrams (mg) to 250 mg of iron. For example, if you received two bags of blood each month, you would have received 400 mg to 500 mg of excess iron.

The amount of excess iron that EXJADE could remove depends on the dose of EXJADE you are taking and your weight.

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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.

The safety and efficacy of EXJADE when taken with other iron chelation medication has not been proven.

EXJADE is available by prescription only.

Important Safety Information About EXJADE

What is the most important safety information to know about EXJADE?

EXJADE may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines. In some cases, these problems were fatal.

These problems occurred more often in elderly patients, patients with high-risk myelodysplastic syndromes, pre-existing kidney or liver problems, or low blood counts.

EXJADE may also cause serious liver problems. In some cases, these problems were fatal. These problems occurred more often in patients greater than 55 years of age.

Your doctor should check your kidneys with a blood test called serum creatinine and/or creatinine clearance:

  • Before taking EXJADE
  • Monthly during treatment

If you already have kidney problems or are at risk for kidney problems your doctor should check your kidneys:

  • Every week for the first month
  • Monthly during treatment

Your doctor should check your liver with blood tests called serum transaminases and bilirubin:

  • Before taking EXJADE
  • Every other week for the first month after starting EXJADE
  • Monthly during treatment

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
  • 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: 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. 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.

*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.