Treatment for Chronic Iron Overload | EXJADE® (deferasirox) tablets for oral suspension

Important Safety Information, including Boxed WARNING:

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. Kidney problems occurred particularly in patients with multiple medical conditions and those who were very ill because of their disease. Bleeding in the stomach or intestines occurred more often in elderly patients. Liver problems were more likely to happen in patients older than 55 years.

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 a history of 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

You should not take EXJADE if you have:

Certain kinds of kidney problems
Pre-existing severe liver problems
High-risk myelodysplastic syndromes (MDS)
Advanced cancer
Low blood counts (low platelets)
An allergy to EXJADE or any ingredient of EXJADE

Kidneys

If you have a pre-existing kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your kidneys, you are at increased risk of complications. Your doctor will give you a blood test (called serum creatinine and/or creatinine clearance) 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 adjust your dose based on the results of these tests
Your doctor may also collect urine samples monthly
Some patients developed severe kidney problems while taking 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

Liver

If you have a pre-existing severe liver problem, you should not use EXJADE
If you have mild or moderate liver problems, 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. Your doctor may adjust your dose based on the results of these tests
Some patients developed severe liver problems, in some cases fatal, while taking EXJADE. Many of these patients were older than 55 years of age and/or had multiple medical conditions already affecting their liver

Bleeding in the Stomach or Intestines

Some patients developed stomach irritation or bleeds while taking 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 (low platelets)
Talk to your doctor if you are taking other drugs that can also irritate your stomach or cause a stomach bleed (eg, pain relievers/anti-inflammatory drugs, corticosteroids, oral bisphosphonates, blood thinners)

Blood Disorders

Some patients developed severe blood disorders, in some cases fatal, while on EXJADE therapy. Having a pre-existing blood disorder may increase the risk
Your doctor will give you a blood test to check your blood counts

Increased Risks When Used in Elderly Patients

Since EXJADE has been on the market, there have been reports of serious reactions, sometimes leading to death. These serious reactions and deaths have happened most often when EXJADE was taken by elderly patients

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 you develop swelling of the throat, a severe rash, hearing problems, or vision disturbances, stop taking EXJADE and contact your doctor immediately

Serious Skin Reactions

Severe skin disorders that result in a very serious rash, called Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme, have been reported during treatment with EXJADE. Other skin reactions, including DRESS (drug reaction with eosinophilia and systemic symptoms), can also occur. If you develop a severe rash, stop taking EXJADE and contact your doctor immediately
Mild to moderate skin rashes may occur during treatment with EXJADE. Let your doctor know if the rash doesn’t go away on its own or gets worse. Your doctor may need to change your dose of EXJADE

Hearing and Vision Changes

Changes to hearing and vision have been reported in patients taking EXJADE. If you notice changes in your hearing or eyesight, contact your doctor immediately
You may also receive a hearing or vision test prior to receiving EXJADE and yearly thereafter. Your doctor may change your dose 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 laboratory values, and skin rash
Let your doctor know if you are experiencing any side effects. Your doctor may need to change your dose
If you experience diarrhea or vomiting, you must continue to drink fluids
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

Taking 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

Talk to your doctor to determine if prescription EXJADE therapy is right for you.

Please see full Prescribing Information, including Boxed WARNING, for EXJADE (deferasirox).

Approved Use:

Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)

EXJADE^® (deferasirox) is indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

In these patients, EXJADE^® lowered the levels of iron in the blood (measured by serum ferritin levels) and liver (measured by liver iron concentration)
An improvement in survival or disease symptoms resulting from reduction in elevated iron levels, however, has not been proven

Treatment of Chronic Iron Overload in Non–Transfusion-Dependent Thalassemia Syndromes

EXJADE is indicated to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non–transfusion-dependent thalassemia (NTDT).

EXJADE should be used when these patients have elevated levels of iron in the liver (measured by liver iron concentration of at least 5 milligrams of iron per gram of dry liver tissue weight) and in the blood (measured by serum ferritin levels greater than 300 mcg/L)
An improvement in survival or disease symptoms resulting from reduction in elevated iron levels, however, has not been proven

Limitations on the Use of EXJADE

It is not known if EXJADE is safe or effective when taken with another therapy that lowers iron levels in the blood
There are patients with a serious blood disorder known as myelodysplastic syndromes (MDS) who may take EXJADE to treat chronically elevated levels of iron in the blood caused by repeated blood transfusions. The iron lowering effects and safety of EXJADE have not been studied in clinical trials specifically designed for just these patients with MDS

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Prescribing Info

Patient Support Line 1-800-987-6543,
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Important Safety Information, including Boxed WARNING:

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 probl...

Approved Use:

Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)

EXJADE^® (deferasirox) is indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients 2 yea...

Important Safety Information, including Boxed WARNING:

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

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 a history of 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

You should not take EXJADE if you have:

Certain kinds of kidney problems
Pre-existing severe liver problems
High-risk myelodysplastic syndromes (MDS)
Advanced cancer
Low blood counts (low platelets)
An allergy to EXJADE or any ingredient of EXJADE

Kidneys

If you have a pre-existing kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your kidneys, you are at increased risk of complications. Your doctor will give you a blood test (called serum creatinine and/or creatinine clearance) 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 adjust your dose based on the results of these tests
Your doctor may also collect urine samples monthly
Some patients developed severe kidney problems while taking 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

Liver

If you have a pre-existing severe liver problem, you should not use EXJADE
If you have mild or moderate liver problems, 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. Your doctor may adjust your dose based on the results of these tests
Some patients developed severe liver problems, in some cases fatal, while taking EXJADE. Many of these patients were older than 55 years of age and/or had multiple medical conditions already affecting their liver

Bleeding in the Stomach or Intestines

Some patients developed stomach irritation or bleeds while taking 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 (low platelets)
Talk to your doctor if you are taking other drugs that can also irritate your stomach or cause a stomach bleed (eg, pain relievers/anti-inflammatory drugs, corticosteroids, oral bisphosphonates, blood thinners)

Blood Disorders

Some patients developed severe blood disorders, in some cases fatal, while on EXJADE therapy. Having a pre-existing blood disorder may increase the risk
Your doctor will give you a blood test to check your blood counts

Increased Risks When Used in Elderly Patients

Since EXJADE has been on the market, there have been reports of serious reactions, sometimes leading to death. These serious reactions and deaths have happened most often when EXJADE was taken by elderly patients

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 you develop swelling of the throat, a severe rash, hearing problems, or vision disturbances, stop taking EXJADE and contact your doctor immediately

Serious Skin Reactions

Severe skin disorders that result in a very serious rash, called Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme, have been reported during treatment with EXJADE. Other skin reactions, including DRESS (drug reaction with eosinophilia and systemic symptoms), can also occur. If you develop a severe rash, stop taking EXJADE and contact your doctor immediately
Mild to moderate skin rashes may occur during treatment with EXJADE. Let your doctor know if the rash doesn’t go away on its own or gets worse. Your doctor may need to change your dose of EXJADE

Hearing and Vision Changes

Changes to hearing and vision have been reported in patients taking EXJADE. If you notice changes in your hearing or eyesight, contact your doctor immediately
You may also receive a hearing or vision test prior to receiving EXJADE and yearly thereafter. Your doctor may change your dose 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 laboratory values, and skin rash
Let your doctor know if you are experiencing any side effects. Your doctor may need to change your dose
If you experience diarrhea or vomiting, you must continue to drink fluids
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

Taking 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

Talk to your doctor to determine if prescription EXJADE therapy is right for you.

Please see full Prescribing Information, including Boxed WARNING, for EXJADE (deferasirox).

Approved Use:

Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)

In these patients, EXJADE^® lowered the levels of iron in the blood (measured by serum ferritin levels) and liver (measured by liver iron concentration)
An improvement in survival or disease symptoms resulting from reduction in elevated iron levels, however, has not been proven

Treatment of Chronic Iron Overload in Non–Transfusion-Dependent Thalassemia Syndromes

EXJADE is indicated to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non–transfusion-dependent thalassemia (NTDT).

EXJADE should be used when these patients have elevated levels of iron in the liver (measured by liver iron concentration of at least 5 milligrams of iron per gram of dry liver tissue weight) and in the blood (measured by serum ferritin levels greater than 300 mcg/L)
An improvement in survival or disease symptoms resulting from reduction in elevated iron levels, however, has not been proven

Limitations on the Use of EXJADE

It is not known if EXJADE is safe or effective when taken with another therapy that lowers iron levels in the blood
There are patients with a serious blood disorder known as myelodysplastic syndromes (MDS) who may take EXJADE to treat chronically elevated levels of iron in the blood caused by repeated blood transfusions. The iron lowering effects and safety of EXJADE have not been studied in clinical trials specifically designed for just these patients with MDS

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Co-pay assistance program* for EXJADE^® (deferasirox) tablets for oral suspension

Commercially insured patients pay no more than $25 per month
Novartis will pay the remaining co-pay, up to $15,000 per calendar year
Call 877-577-7756, or go to www.copay.novartisoncology.com to find out if you are eligible
Provide the co-pay information to your specialty pharmacy and follow up to confirm the offer has been applied

*Limitations apply. This offer is not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions go to www.copay.novartisoncology.com.

Patient Assistance Now Oncology

Novartis Oncology is committed to helping patients who are living with cancer receive the medicines they need. Patient Assistance Now Oncology (PANO) offers quick and easy access to information about our wide range of resources.

You can get information about our PANO support programs in 2 ways:

Call 1-800-282-7630 to speak with a member of our knowledgeable staff dedicated to making access to therapy as simple and convenient as possible; or
Visit our website at: www.OncologyAccessNow.com/patient

EXJADE® (deferasirox) tablets for oral suspension

Co-pay assistance program* for EXJADE® (deferasirox) tablets for oral suspension

Patient Assistance Now Oncology

EXJADE^® (deferasirox) tablets for oral suspension

Co-pay assistance program* for EXJADE^® (deferasirox) tablets for oral suspension