Deferasirox

Deferasirox is a prescription medication used to remove the extra iron that builds up in people who receive repeated blood transfusions and in people with an inherited blood disorder called non-transfusion-dependent thalassemia (NTDT). Deferasirox belongs to a group of drugs called iron chelators. It works by attaching to iron in the body so that it can be removed from the body in feces.

This medication comes in a tablet to be dissolved in liquid. It is taken by mouth on an empty stomach (at least 30 minutes before eating), once daily.

Deferasirox also comes in a tablet form. It is taken by mouth on an empty stomach or with a light meal (contains less than 7% fat content and approximately 250 calories), once daily.

Common side effects of deferasirox include nausea, vomiting, diarrhea, and stomach pain. Deferasirox can cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Deferasirox is a prescription medication used for the treatment of chronically (long-lasting) elevated iron blood levels caused by:

• repeated blood transfusions in patients 2 years of age and older
• a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT) in patients 10 years of age and older

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Deferasirox may be found in some form under the following brand names:

• Exjade

• Jadenu

Serious side effects have been reported. See "Drug Precautions" section.

Common side effects include:

• nausea
• vomiting
• diarrhea
• stomach pain
• increases in kidney laboratory values
• skin rash

​This is not a complete list of deferasirox side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other iron chelating agents
• birth control pills and other hormonal contraceptive medications
• diabetes medications
• seizure medications such as phenytoin (Dilantin) and phenobarbital (Luminal)
• cholesterol-lowering drugs such as simvastatin (Zocor, in Simcor, in Vytorin)
• cholestyramine (Questran, Prevalite)
• colesevelam (Welchol)
• colestipol (Colestid)
• aluminum-containing antacids such as Amphogel, Alternagel, Gaviscon, Maalox, or Mylanta
• cyclosporine (Gengraf, Neoral, Sandimmune)
• repaglinide (Prandin, in Prandimet)
• ritonavir (Norvir)
• anticoagulants ("blood thinners") such as warfarin (Coumadin, Jantoven)
• bisphosphonates such as alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel, Atelvia), and others
• rifampin (Rimactane, Rifadin)

This is not a complete list of deferasirox drug interactions. Ask your doctor or pharmacist for more information.

Deferasirox 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 deferasirox
• 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 deferasirox
• Every other week for the first month after starting deferasirox
• Monthly during treatment

Other serious side effects can occur including:

Blood Disorders. Some patients developed severe blood disorders, in some cases fatal, while on deferasirox 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 deferasirox 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 deferasirox was taken by elderly patients.

Allergic Reactions. Serious allergic reactions (which include swelling of the throat) have been reported in patients taking deferasirox, usually within the first month of treatment. If you develop swelling of the throat, a severe rash, hearing problems, or vision disturbances, stop taking deferasirox and contact your doctor immediately.

Serious Rash. A skin disorder that results in a very serious rash, called erythema multiforme, has been reported during treatment with deferasirox. If you develop a severe rash, stop taking deferasirox and contact your doctor immediately.

Hearing and Vision Changes. Changes to hearing and vision have been reported in patients taking deferasirox. 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 deferasirox and yearly thereafter. Your doctor may change your dose based on the results of these tests.

Do not take deferasirox 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 any ingredient in this medication

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of deferasirox, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking deferasirox, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to deferasirox or any ingredient of deferasirox
• have kidney problems
• have severe liver problems
• have high-risk myelodysplastic syndromes (MDS)
• have advanced cancer
• have low blood platelet counts

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Deferasirox falls into category C. In animals studies, pregnant animals were given this medication and had some babies born with problems. There are no well-controlled studies that have been done in humans with deferasirox, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if deferasirox crosses into human milk, although deferasirox is passed through breast milk in animals. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using deferasirox.

Take deferasirox exactly as prescribed.

Deferasirox comes as a tablet for suspension (a tablet to dissolve in liquid) to take by mouth and tablet form.

Exjade (deferasirox) tablet for suspension:

Do not chew or swallow the tablets whole. Always dissolve the tablets in liquid (water, apple juice, or orange juice) before taking them as follows:

• Drop your deferasirox tablet(s) into a glass of orange juice, apple juice, or water. You can also use the deferasirox mixer each day when taking your deferasirox. Make sure that you use the amount of liquid directed by your doctor.
• Stir the liquid and deferasirox tablet(s) until you have an even mixture. The consistency of the mixture may be thick.
• Drink all of the deferasirox mixture. Add more juice or water to mix anything that's left over. And then drink that.
• Deferasirox should be taken on an empty stomach once daily, at least 30 minutes before eating.

Jadenu (deferasirox) tablet:

Take deferasirox by mouth on an empty stomach or with a light meal (contains less than 7% fat content and approximately 250 calories), once daily.

Take deferasirox with water or other liquids.

Take deferasirox at the same time every day.

Do not take more or less of it or take it more often than prescribed by your doctor.

Take deferasirox exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The deferasirox dose your doctor recommends will be based on:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight

Transfusional Iron Overload

If you take too much deferasirox call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at room temperature between 15–30°C (59–86°F).
• Keep this and all medications out of the reach of children.

WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE

Renal Failure

• Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.
• Measure serum creatinine and determine creatinine clearance in duplicate prior to initiation of therapy and monitor renal function at least monthly thereafter. For patients with baseline renal impairment or increased risk of acute renal failure, monitor creatinine weekly for the first month, then at least monthly. Consider dose reduction, interruption, or discontinuation based on increases in serum creatinine.

Hepatic Failure

• Deferasirox can cause hepatic injury including hepatic failure and death.
• Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter.
• Avoid use of deferasirox in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child Pugh B) hepatic impairment. 

Gastrointestinal Hemorrhage

• Deferasirox can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.
• Monitor patients and discontinue deferasirox for suspected GI ulceration or hemorrhage.