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.

helping your child
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Helping Your Child

If your child has a disease such as anemia that requires frequent doctor's visits, multiple blood transfusions, and treatment for chronic iron overload due to blood transfusions, you know how important it is to stay on top of your child's health. Here are some suggestions for managing your child's iron levels by using EXJADE.

Giving Your Child EXJADE

EXJADE is a once-daily medicine. And because it is taken as a drink, EXJADE does not require pumps or infusions.

Use these tips to help your child take EXJADE correctly. You can print them out and put them on your refrigerator or somewhere handy for when you need them.

  • Make sure your child takes EXJADE once a day, every day of the week
  • Have your child take EXJADE at the same time each day
  • Have your child take EXJADE on an empty stomach
  • Make sure your child waits at least 30 minutes before eating
  • Prepare the correct amount of EXJADE — the dose your child's doctor prescribed — by counting the number of tablets
  • Remind your child not to chew the tablets or swallow them whole
  • Drop the tablets into the amount of liquid the doctor has recommended; you may mix the tablet(s) in water, orange juice, or apple juice
  • Disperse doses of <1 g in 3.5 ounces and doses of ≥ 1 g in 7.0 ounces of liquid
  • Stir the tablet or tablets until it is/they are evenly mixed. This takes about three minutes. The mixture might become thick
  • If any part of EXJADE remains in the glass or on the spoon (or stirrer) after your child drinks, add more water, orange juice, or apple juice, and have him or her drink again until all the medicine is gone

When your child takes EXJADE, he or she should not take antacids such as Maalox®* that contain aluminum.*

*Maalox is a registered trademark of Novartis Consumer Health, Inc.

Your Child's Dosing for EXJADE

EXJADE comes in several strengths to help reduce or maintain your child's iron levels. Based on the goals of your child's treatment, your child's doctor will decide the best dose for your child. And your child's doctor will evaluate the dose periodically to be sure EXJADE is working properly. The recommended initial starting dose for EXJADE is 20 mg/kg. Doses should not exceed the maximum dose of 40 mg/kg.

Talk with your child's doctor or pharmacist if you have any questions about giving your child EXJADE.


Keeping Track of Your Child's Blood Transfusions

Having multiple blood transfusions may put your child at risk for chronic iron overload due to blood transfusions. Even though your child's body cannot get rid of the extra iron on its own, there are treatment options. Your child's doctor knows about treatment that can help get rid of the extra iron your child's body will not use.

Tracking your child's blood transfusions is one way you can help take care of his or her health.

The easiest way to track all the transfusions your child has ever had is to write them down. If your child has already had some transfusions but you do not remember how many, ask your child's doctor or the nurse at your transfusion center to help you.

You can also ask your child to help you write down his or her transfusions with a favorite color pen, pencil, or crayon. Doing so can help your child learn important ways to begin taking care of his or her health.

Remember to keep the list somewhere handy, like on the refrigerator. Seeing the list will remind you to take it with you when your child visits his or her doctor or transfusion center.

Having a record of all of your child's transfusions in one place also can help your child's doctor know when he or she might need treatment for too much iron.


Keeping Track of Your Child's Serum Ferritin Levels

When your child's doctor wants to check your child's iron levels, he or she will give your child a blood (or serum ferritin) test. It is the most common way to find out the level of iron in your child's body. And keeping track of the results of your child's serum ferritin tests is one way you can help care for your child's health.

Your child should continue taking EXJADE until your doctor says otherwise. Stopping EXJADE too soon might mean your child will not get enough extra iron out of his or her body. It also is important to continue monitoring your child's iron (or serum ferritin) levels. That way, your child's doctor will know when and for how long he or she might need to take EXJADE.

The easiest way to keep track of the results from your child's serum ferritin tests is to write them down. If your child has already had some test results but you do not remember them, ask your child's doctor to help you.

You also can ask your child to help you write down his or her serum ferritin test results with a favorite color pen, pencil, or crayon. Doing so can help your child learn important ways to begin taking care of his or her health.

Put your child's record somewhere handy, like on your refrigerator. Seeing the record will remind you to take it with you when your child visits his or her doctor.

Having a record of all your child's serum ferritin tests in one place also can help your child's doctor know when he or she might need treatment for too much iron. Treating chronic iron overload due to blood transfusions is important to your child's health.

 
 

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.