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.

understanding chronic iron overload due to blood transfusions
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FAQs



Risk

Q: Who is at risk for chronic iron overload due to blood transfusions?
A: People who have had 10 or more blood transfusions (or 20 transfused units of blood), including those with anemias that require blood transfusions, or those who have had transfusions for any other reason, are at risk for chronic iron overload due to blood transfusions. Use the Risk Assessment Tool to find out if you are at risk. Talk with your doctor to learn more about chronic iron overload due to blood transfusions.


Chronic Iron Overload Due To Blood Transfusions and Anemia

Q: Is it possible to have chronic iron overload due to blood transfusions and still be anemic?
A: Yes. Although blood transfusions help keep people with anemia healthy, they add extra iron to the body. People who continue to have transfusions might eventually have too much iron in their bodies. If you have had blood transfusions, use the Risk Assessment Tool to find out if you might be at risk for chronic iron overload due to blood transfusions. Then ask your doctor about your risk, how to get screened, and whether you might need treatment with EXJADE , the only once-daily oral therapy indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients aged 2 years and older, to help you get rid of the excess iron . Further studies are being performed to determine the long-term benefits and risks of EXJADE.


Risk for Chronic Iron Overload Due To Blood Transfusions

Q: How many transfusions put me at risk for chronic iron overload due to blood transfusions?
A: Ten or more blood transfusions increase your risk for chronic iron overload due to blood transfusions. If you have had blood transfusions, use the Risk Assessment Tool to find out about your risk. Then ask your doctor to order a simple blood test called the serum ferritin test to find out whether you have chronic iron overload due to blood transfusions. If your serum ferritin level is consistently greater than 1000 mcg/L, you may need treatment.

Q: If I had multiple transfusions many years ago, am I still at risk for chronic iron overload due to blood transfusions?
A: Yes. Risk for chronic iron overload due to blood transfusions is calculated by the total number of blood transfusions you have had in your lifetime. If you cannot remember how many transfusions you have had but think you might be at risk, your doctor can order a simple blood test known as a serum ferritin test to find out if you have chronic iron overload due to blood transfusions.

Q: Should I keep a record of all my blood transfusions?
A: Yes. Each time you receive a blood transfusion, you should write down the date and the number of units of blood you were given. When the number of total units is near or more than 20, ask your doctor whether you might be at risk for chronic iron overload due to blood transfusions.


Knowing Whether You Have Chronic Iron Overload Due To Blood Transfusions

Q: How will I know if I have chronic iron overload due to blood transfusions?
A: One way to know if you have chronic iron overload due to blood transfusions is to have a simple blood test, called a serum ferritin test. This test measures the amount of iron in your body. Ask your doctor whether the serum ferritin test is right for you.

Q: Should I get a serum ferritin test?
A: The serum ferritin test is a simple blood test and the most common way to tell whether you have too much or too little iron in your body. If you have had 10 or more blood transfusions in your lifetime, ask your doctor if you should have a serum ferritin test.

Q: Where can I get a serum ferritin test?
A: Your doctor can order a serum ferritin test for you. He or she might send you to a laboratory to have your blood drawn for the test.

Q: What is a serum ferritin test like?
A: The nurse or technician will use a thin needle to take blood from a vein in the back of your hand or your arm. The procedure takes only a few minutes.

Q: Does the serum ferritin test hurt?
A: As with any blood test, you might feel a slight pinch when the needle is inserted.

Q: Without a test, can I tell if I have chronic iron overload due to blood transfusions?
A: No. The symptoms for chronic iron overload due to blood transfusions are not obvious. You may not feel sick or different right away so ask your doctor about a serum ferritin test to find out if you have chronic iron overload due to blood 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 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.