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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Are You at Risk?

Risk for chronic iron overload due to blood transfusions is determined by the total number of blood transfusions (or transfused units) a person has had in his or her lifetime. Having 10 or more blood transfusions (or 20 transfused units of blood) can put a person at risk for chronic iron overload due to blood transfusions. This is true even if years have passed between transfusions because the body cannot naturally get rid of iron and will store the extra iron.


Risk Assessment Tool

Tracking Your Transfusions

Tracking all your transfusions is important in knowing your risk for chronic iron overload due to blood transfusions. Tracking your transfusions can help you and your doctor know when you might be at risk for chronic iron overload due to blood transfusions. This will also help you and your doctor decide if you should be screened or treated 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. 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. If you cannot remember all your transfusions, ask the nurse at your transfusion center to help you.

Some Diseases That Might Require Blood Transfusions

Sickle Cell Disease
People with sickle cell disease (SCD) have too little oxygen in their red blood cells. This condition results in stiff, deformed (or sickle-shaped) blood cells that can cause blockages in blood vessels. This process prevents tissues in the body from getting the oxygen they need to stay healthy.

SCD can be painful, especially if it causes blockages in the lungs (making it difficult to breathe) and the limbs (causing painful swelling). Leg ulcers, gallstones, high blood pressure in the lungs, an enlarged spleen, and stroke also can occur as a result of complications from SCD.

Myelodysplastic Syndromes
People with myelodysplastic syndromes (MDS) do not produce enough healthy blood cells — a condition that can lead to anemia, infections, and bleeding. Although almost half of all people with MDS have no symptoms, some people complain of feeling tired or cold and having shortness of breath or chest pain. In some people, complications from MDS can include an enlarged spleen, skin sores, fever, and immune system problems.

Thalassemia
People with thalassemia lack certain important proteins in their red blood cells. As a result, the blood cells do not form properly and cannot carry enough oxygen from the lungs to other parts of the body. People with thalassemia may feel tired, look pale, and have a poor appetite. They may also have slowed growth and development, weak or brittle bones (osteoporosis), a larger-than-normal spleen, and dark urine.

Diamond-Blackfan Anemia
People with Diamond-Blackfan anemia have too few red blood cells to carry oxygen needed for tissues throughout the body. Almost half of all people with Diamond-Blackfan anemia also have symptoms common to other anemias, including pale skin, sleepiness, rapid heartbeat, and heart murmurs. Some people with Diamond-Blackfan anemia have abnormalities affecting the face, head, and hands, as well as heart and kidney defects. Children with the disease may be short for their age. To describe the group of signs and symptoms, the overall disorder often is called Diamond-Blackfan syndrome.

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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.