Screening and Monitoring

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

Screening and Monitoring

Getting screened is important to find out if you have chronic iron overload due to blood transfusions.

Serum Ferritin Testing

The first step in being screened for chronic iron overload due to blood transfusions is to have a simple blood test known as the serum ferritin test. 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.

Normal serum ferritin levels are 12-150 micrograms per liter (mcg/L) for women, and 12-300 mcg/L for men, according to the National Institutes of Health. People who have iron levels greater than 1000 mcg/L may need to be considered for treatment (iron chelation therapy) with a medication such as EXJADE to remove the extra iron.

Other tests that measure iron in the body include liver biopsy and magnetic resonance imaging (MRI).Talk with your doctor if you would like to know more about screening options for chronic iron overload due to blood transfusions.

Liver Biopsy

Liver biopsy can measure how much iron is stored in the liver. Liver biopsies are usually given if the liver is swollen, liver damage is suspected, and after a blood test shows there is too much iron in the body. If your biopsy shows that you have too much iron, your doctor may discuss treatment options to remove the extra iron.

Magnetic Resonance Imaging (MRI)

Magnetic resonance imaging (MRI) is a painless, safe, and noninvasive way to get quick, accurate results about iron levels in your liver. If you have had multiple blood transfusions and think you might be at risk for chronic iron overload due to blood transfusions, ask your doctor about screening and diagnosis to find out whether you might need a serum ferritin or other screening test.

Monitoring Your Iron Levels

Even after you've been diagnosed and treated for chronic iron overload due to blood transfusions, monitoring your iron levels is important. It's the only way for your doctor to be sure your iron (or serum ferritin) levels are under control.

Remember, your body cannot get rid of extra iron on its own. But the good news is EXJADE is an iron chelation therapy to treat chronic iron overload due to blood transfusions in patients 2 years of age and older. If you have chronic iron overload due to blood transfusions, ask your doctor about EXJADE.

If you continue to have blood transfusions, ask your doctor when you should be monitored to find out if your iron levels have changed. Knowing your iron levels will help your doctor judge whether and how long you might need treatment with EXJADE.

Tracking Your Serum Ferritin Levels

Keep a record of your serum ferritin test results. Ask your doctor to tell you the results of your tests. Then each time you visit your doctor, write them down so he or she can review your serum ferritin levels and decide whether you might need treatment.

Helpful Tips

Here are some steps you can take to make it easier for you and your doctor to know when you might need monitoring and treatment for chronic iron overload due to blood transfusions:

Track your transfusions
Keep the results of your serum ferritin tests
Talk with your doctor about chronic iron overload due to blood transfusions, your risk, and whether you might need treatment with EXJADE, a therapy to get rid of extra iron
If you continue to have blood transfusions, ask your doctor whether monitoring shows that your iron levels have changed
Ask your doctor when he or she thinks you might need treatment for chronic iron overload due to blood transfusions and whether 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, might be right for you. Further studies are being performed to determine the long-term benefits and risks of EXJADE

DELIVERY AND REIMBURSEMENT SUPPORT PROGRAM

and understand
how it might
help you reduce
excess iron
levels from blood
transfusions.

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.