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DEFERASIROX tablet, for suspension


  1. Deferasirox Can Cause Serious Side Effects, Including:
  2. Your Healthcare Provider Should Do Blood And Urine Tests To Check Your Or Your Child S Kidney Function Before And During Treatment With Deferasirox.call Your Or Your Child S Healthcare Provider Right Away If:
  3. Deferasirox Is A Prescription Medicine That Is Used To Treat:
  4. Avoid Taking The Following Medicines During Treatment With Deferasirox:
  5. N Cause Serious Side Effects, Including:
  6. Get Medical Help Right Away If You Develop Any Of The Following Symptoms Of A Serious Allergic Reaction Including:
  7. Nd Can Be Life-threatening Or Lead To Death. Get Medical Help Right Away If You Develop Any One Or More Of The Following Signs And Symptoms Of A Severe Skin Reaction, Including:
  8. Patient Information

Deferasirox Can Cause Serious Side Effects, Including: 

Kidney problems.Deferasirox can cause sudden (acute) kidney problems, including kidney failure that may require treatment with dialysis, and may cause death. Deaths have happened mostly in people who also have other health problems and had a blood disorder that was in an advanced stage. Adults and children who already have kidney problems and are taking certain medicines with deferasirox may also have an increased risk of sudden kidney problems. Be sure to tell your healthcare provider about all the medicines you take during treatment with deferasirox.

Your Healthcare Provider Should Do Blood And Urine Tests To Check Your Or Your Child S Kidney Function Before And During Treatment With Deferasirox.call Your Or Your Child S Healthcare Provider Right Away If: 

  • your child becomes sick with fever, vomiting, or diarrhea and cannot drink fluids normally during treatment with deferasirox.Your child may be dehydrated. Your child s healthcare provider may need to temporarily stop treatment with deferasirox and treat your child for dehydration to help prevent kidney problems. Your child s healthcare provider may monitor your child s kidney function more closely.
  • you notice that you or your child are passing less urine than usual during treatment with deferasirox.

Liver problems.Deferasirox can cause liver problems, including liver failure that can sometimes cause death. Liver problems with deferasirox may be more common in people who are over 55 years of age but can also happen in children. Liver failure has happened more often in people with cirrhosis of the liver and failure of other organs. Liver failure has also happened along with kidney problems in certain children who become dehydrated.

Deferasirox Is A Prescription Medicine That Is Used To Treat: 

  • people 2 years of age and older who have an increased amount of iron in their blood for a long period of time (chronic), caused by repeated blood transfusions

It is not known if deferasirox is safe and effective when used with other medicines to treat an increased amount of iron in the blood.

It is not known if deferasirox is safe and effective for treating children under 2 years of age who have an increased amount of iron in their blood for a long period of time (chronic) caused by repeated blood transfusions.

Do not takedeferasiroxif you:

  • have certain kidney problems
  • have high-risk myelodysplastic syndrome (MDS)
  • have advanced cancer
  • have a low platelet count
  • are allergic to deferasirox or any of the ingredients in deferasirox.

Avoid Taking The Following Medicines During Treatment With Deferasirox: 

  • antacid products (medicines used to treat heartburn) that contain aluminum
  • theophylline
  • certain medicines to lower your cholesterol, called bile acid sequestrants.

Ask your healthcare provider if you are not sure if you take one of these medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I takedeferasirox?

  • Take deferasirox exactly as your healthcare provider tells you to.
  • Do not change your dose of deferasirox or stop taking it unless your healthcare provider tells you to.
  • Take deferasirox 1 time every day, preferably at the same time every day.
  • Take deferasirox on an empty stomachat least 30 minutes before eating food.
  • Do notchew deferasirox tablets or swallow them whole.
  • Place the prescribed number of deferasirox tablets in a cup with water, orange juice, or apple juice. Stir to disperse the tablets in the liquid.
  • If your prescribed dose of deferasirox is less than 1 gram, use 3.5 ounces of liquid to disperse the tablets.
  • If your prescribed dose of deferasirox is 1 gram or more, use 7 ounces of liquid to disperse the tablets.
  • Completely disperse the tablets until it becomes a fine suspension Then drink the suspension right away.
  • Do notdisperse deferasirox tablets in carbonated drinks or milk.
  • After drinking the suspension, add a small amount of water, orange juice, or apple juice to the cup to disperse any remaining medicine, and then drink it.
  • Do not take deferasirox with aluminum-containing antacid products.

    • Deferasirox may cause dizziness. Avoid driving or operating machinery until you know how deferasirox affects you. Do not drive or operate machinery if deferasirox makes you dizzy.

    What are the possible side effects ofdeferasirox?

    Deferasiroxca

N Cause Serious Side Effects, Including: 

  • See What is the most important information I should know aboutdeferasirox?
  • Effects on your bone marrow.Deferasirox can affect your bone marrow and cause you to have low white blood cell count which can be serious, decreased platelets, or worsening of your anemia, and may lead to death. Your risk for effects on your bone marrow may be increased if you already have other blood disorders. Your healthcare provider will do blood tests to monitor your blood cell counts for these problems.
  • Serious allergic reactions.Deferasirox may cause serious allergic reactions, which usually start within the first month of treatment.

Get Medical Help Right Away If You Develop Any Of The Following Symptoms Of A Serious Allergic Reaction Including: 

  • difficulty in breathing or swallowing
  • swelling of the face, lips, mouth, tongue or throat
  • chest pain
  • severe itching of the skin with a red rash or raised bumps
  • rapid heartbeat
  • hives
  • feeling faint
  • Skin rash and severe skin reactions.Skin rashes are common with deferasirox. If you get a more severe rash, your healthcare provider may temporarily stop deferasirox.

Severe skin reactions can also happen withdeferasiroxa

Nd Can Be Life-threatening Or Lead To Death. Get Medical Help Right Away If You Develop Any One Or More Of The Following Signs And Symptoms Of A Severe Skin Reaction, Including: 

  • rash or red skin
  • skin peeling
  • blisters on your lips, or around your mouth or eyes
  • high fever or flu-like symptoms
  • mouth sores
  • enlarged lymph nodes
  • Hearing and vision problems.Deferasirox can cause decreased hearing and changes in your vision including cataracts, increased pressure in your eye, and problems with your retinas. Your healthcare provider should do hearing and vision tests before you start and then regularly during treatment. Your healthcare provider may decrease your dose or stop deferasirox if you develop hearing or vision problems.

Tell your healthcare provider if you develop any changes in your vision or hearing during treatment with deferasirox.

The most common side effects in anyone who takes deferasirox include: diarrhea and nausea.

Other common side effects in people with too much iron in their blood due to repeated blood transfusions include: vomiting, stomach-area (abdomen) pain, and an abnormal kidney function blood test.

These are not all the possible side effects of deferasirox.

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

How should I store deferasirox?

  • Store deferasirox at room temperature between 68 F to 77 F (20 C to 25 C).
  • Keep the bottle closed tightly and away from moisture.
Keep deferasirox and all medicines out of the reach of children.

General information about the safe and effective use ofdeferasirox.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use deferasirox for a condition for which it was not prescribed. Do not give deferasirox to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about deferasirox that is written for health professionals.

What are the ingredients indeferasirox?

Active ingredient: deferasirox

Inactive ingredients: Colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.

Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation s EXJADE (deferasirox) tablets for oral suspension. However, due to Novartis Pharmaceuticals Corporation s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

For more information, call 1-888-838-2872

This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. B 10/2019

Patient Information 

Dosing Instructions

Advise patients to take deferasirox tablet once daily on an empty stomach at least 30 minutes prior to food, preferably at the same time every day. Instruct patients to completely disperse the tablets in water, orange juice, or apple juice, and drink the resulting suspension immediately. After the suspension has been swallowed, resuspend any residue in a small volume of the liquid and swallow[see Dosage and Administration (2.3)].

Advise patients not to chew tablets or swallow them whole[see Dosage and Administration (2.3)].

Blood Testing

Advise patients that blood tests will be performed frequently to check for damage to kidneys, liver, or blood cells[see Warnings and Precautions (5.1,5.2,5.3,5.4,5.5)].

Acute Kidney Injury, Including Acute Renal Failure

Caution patients about the potential for kidney toxicity when taking deferasirox. Inform patients of the signs and symptoms of kidney injury. Advise patients to contact their healthcare provider immediately if they experience any of thesesymptoms [see Warnings and Precautions (5.1)].

Hepatic Toxicity and Failure

Caution patients about the potential for hepatic toxicity when taking deferasirox. Inform patients of the signs and symptoms of hepatic toxicity. Advise patients to contact their healthcare provider immediately if they experience any of these symptoms[see Warnings and Precautions (5.2)].

Gastrointestinal Ulceration and Hemorrhage

Caution patients about the potential for the development of GI ulcers or bleeding when taking deferasirox in combination with drugs that have ulcerogenic or hemorrhagic potential, such as NSAIDs, corticosteroids, oral bisphosphonates, or anticoagulants. Inform patients of the signs and symptoms of GI ulcers or bleeding. Advise patients to contact their health care provider for symptoms of heartburn but to seek immediate medical attention for symptoms of gastrointestinal hemorrhage[see Warnings and Precautions (5.3)].

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 reactions are severe, advise patients to stop taking deferasirox immediately and seek immediate medical attention[see Warnings and Precautions (5.7)].

Severe Skin Reactions

Severe skin reactions have been reported in patients taking deferasirox. Inform patients of the signs and symptoms of severe skin reactions. If reactions are severe, advise patients to stop taking deferasirox immediately and seek immediate medical attention[see Warnings and Precautions (5.8)].

Skin Rash

Skin rashes may occur during deferasirox treatment. If the skin rash is severe, advise patients to stop taking deferasirox and seek medical attention[see Warnings and Precautions (5.9)].

Pediatric Patients with Acute Illness

Instruct pediatric patients and their caregivers to contact their healthcare provider during episodes of acute illness, especially if the patient has not been drinking fluids or the patient has volume depletion due to fever, vomiting, or diarrhea[see Warnings and Precautions (5.1)].

Auditory and Ocular Testing

Because auditory and ocular disturbances have been reported with deferasirox, conduct auditory testing and ophthalmic testing before starting deferasirox treatment and thereafter at regular intervals. Advise patients to contact their healthcare provider if they develop visual or auditory changes during treatment[see Warnings and Precautions (5.10)].

Drug Interactions

Caution patients not to take aluminum-containing antacids and deferasirox simultaneously[see Drug Interactions (7.1)].

Caution patients about potential loss of effectiveness of drugs metabolized by CYP3A4 (e.g., cyclosporine, simvastatin, hormonal contraceptive agents) when deferasirox is administered with these drugs[see Drug Interactions (7.2)].

Caution patients about potential loss of effectiveness of deferasirox when administered with drugs that are potent UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir). Based on serum ferritin levels and clinical response, consider increases in the dose of deferasirox when concomitantly used with potent UGT inducers[see Drug Interactions (7.5)].

Caution patients about potential loss of effectiveness of deferasirox when administered with drugs that are bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol). Based on serum ferritin levels and clinical response, consider increases in the dose of deferasirox when concomitantly used with bile acid sequestrants[see Drug Interactions (7.6)].

Caution patients with diabetes to monitor their glucose levels more frequently when repaglinide is used concomitantly with deferasirox[see Drug Interactions (7.3)].

Driving and Using Machines

Caution patients experiencing dizziness to avoid driving or operating machinery[see Adverse Reactions (6.1)].

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. G 7/2019



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