Exjade

DRUG DESCRIPTION

Exjade (deferasirox) is an iron chelating agent. Exjade tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1yl]-benzoic acid and its structural formula is

EXJADE® (deferasirox) Structural Formula Illustration

Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4.

Inactive Ingredients: Lactose monohydrate (NF), crospovidone (NF), povidone (K30) (NF), sodium lauryl sulphate (NF), microcrystalline cellulose (NF), silicon dioxide (NF), and magnesium stearate (NF).

What are the possible side effects of deferasirox (Exjade)?

Stop using deferasirox and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • weakness or fainting, bloody or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • severe stomach pain that may spread to your back;
  • increased thirst and urination, loss of appetite, weakness, constipation;
  • ...

Read All Potential Side Effects and See Pictures of Exjade »

What are the precautions when taking deferasirox (Exjade)?

Before taking deferasirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, low platelet counts.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you have diarrhea or vomiting, drink plenty of fluids to replace lost body water and minerals. Ask your doctor or pharmacist for more details.

Kidney function...

Read All Potential Precautions of Exjade »


Exjade Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, dizziness, headache, fever, and stomach/abdominal pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: trouble sleeping, hearing loss, unusual feelings of restlessness/high energy (hyperactivity), vision changes.

This drug may rarely cause serious (even fatal) liver disease. If you notice any of the following unlikely but serious side effects, tell your doctor immediately: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing of eyes/skin.

This drug may rarely cause serious (even fatal) stomach/intestinal bleeding and ulcers. Tell your doctor immediately if you have any of the following rare but serious symptoms: severe stomach/abdominal pain, black/tarry/bloody stools, vomit that looks like coffee grounds.

This drug may rarely cause serious (even fatal) kidney or blood problems. Tell your doctor immediately if you notice any of the following symptoms: change in amount of urine, easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), unusual tiredness.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Deferasirox can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking deferasirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, low platelet counts.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you have diarrhea or vomiting, drink plenty of fluids to replace lost body water and minerals. Ask your doctor or pharmacist for more details.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Exjade Patient Information Including Side Effects

Brand Names: Exjade

Generic Name: deferasirox (Pronunciation: de FER a sir ox)

  • What is deferasirox (Exjade)?
  • What are the possible side effects of deferasirox (Exjade)?
  • What is the most important information I should know about deferasirox (Exjade)?
  • What should I discuss with my healthcare provider before using deferasirox (Exjade)?
  • How should I take deferasirox (Exjade)?
  • What happens if I miss a dose (Exjade)?
  • What happens if I overdose (Exjade)?
  • What should I avoid while taking deferasirox (Exjade)?
  • What other drugs will affect deferasirox (Exjade)?
  • Where can I get more information?

What is deferasirox (Exjade)?

Deferasirox binds to iron and removes it from the blood stream.

Deferasirox is used to treat iron overload caused by blood transfusions in adults and children at least 2 years old.

Deferasirox may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of deferasirox (Exjade)?

Stop using deferasirox and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • weakness or fainting, bloody or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • severe stomach pain that may spread to your back;
  • increased thirst and urination, loss of appetite, weakness, constipation;
  • problems with vision or hearing;
  • severe skin rash;
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, sore throat, body aches, flu symptoms;
  • urinating less than usual or not at all;
  • swelling or numbness in your hands or feet; or
  • nausea, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild stomach pain, diarrhea, nausea or vomiting;
  • fever;
  • dizziness, anxiety, tired feeling;
  • sleep problems (insomnia);
  • mild skin rash, discolored skin; or
  • headache, cough, sinus pain, runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about deferasirox (Exjade)?

Before taking deferasirox, tell your doctor if you have kidney or liver disease, a history of stomach or intestinal bleeding, or problems with your hearing or vision.

Take deferasirox on an empty stomach, at least 30 minutes before you eat.

Do not chew, crush, or swallow the deferasirox tablet whole. Place it into a glass of water, orange juice, or apple juice and allow the tablet to disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.

Stop using this medication and call your doctor if you have a severe skin rash, weakness or fainting, bloody or tarry stools, coughing up blood, severe stomach pain spreading to your back, vision or hearing loss, easy bruising or bleeding, fever, chills, flu symptoms, urinating less than usual or not at all, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

While you are taking deferasirox, do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

There are many other medicines that can interact with deferasirox. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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