Understanding
Chronic Iron Overload
Due to Blood Transfusions

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

Importance of Iron in Your Body

Iron is a critical element that allows cells in the body to get the oxygen needed for many essential body functions. Many cells in the body use iron, including blood cells, muscle cells, liver cells, bone marrow and spleen.

For example, iron helps:

Blood carry oxygen from the lungs to the muscles and other tissues
Produce connective tissues
Produce some transmitters in the brain
Maintain the immune system
Produce red blood cells

Although it is important to have enough iron in your body, having too much iron results in chronic iron overload due to blood transfusions.

Because blood transfusions result in extra iron, people who have had 10 or more blood transfusions (or 20 transfused units of blood) are at risk for chronic iron overload due to blood transfusions. This can include people who need blood transfusions to treat various anemias.

A simple blood test known as a serum ferritin test can tell whether there is too much iron in your body. And if you have too much iron, EXJADE is an effective therapy to help get rid of the excess iron.

Chronic iron overload due to blood transfusions can happen even if years have passed between transfusions because the body stores extra iron; it cannot get rid of it on its own.

In addition, it is possible to have chronic iron overload due to blood transfusions and still be anemic. For this reason, someone who is anemic might need treatment while still having blood transfusions to treat anemia.

If you have chronic iron overload due to blood transfusions, only your doctor can decide whether treatment is right for you. But with treatment like EXJADE, you can have the blood transfusions you need to stay healthy while managing your iron levels. EXJADE is 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. Further studies are being performed to determine the long-term benefits and risks of EXJADE.

Chronic iron overload due to blood transfusions does not have obvious symptoms. For example, although some people with chronic iron overload due to blood transfusions might feel tired, lose interest in sex, have joint pain, or experience changes in skin color, their symptoms often can be confused with their underlying disease (for example, anemia), aging, or lack of sleep.That is why it is important to understand chronic iron overload due to blood transfusions.

Also in this Section

> Find out about your risk for chronic iron overload due to blood transfusions

> Learn about screening with a simple blood (or serum ferritin) test

> Find the answers to common questions about chronic iron overload due to blood transfusions

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.