(de fer' a sir ox)
Deferasirox may cause serious or life-threatening damage to the kidneys or liver or severe bleeding in the stomach or intestines. The risk that you will develop these conditions is greater if you are elderly or if you have any of the following conditions: high risk myelodysplastic syndrome (a severe problem with the bone marrow that has a high risk of developing into cancer), a low level of platelets ( a type of blood cell that is needed to control bleeding), or kidney or liver disease. The risk that you will develop severe bleeding in the stomach or intestines may be greater if you are taking any of the following medications: anticoagulants (blood thinners) such as warfarin (Coumadin); aspirin or other nonsteroidal anti-inflammatory medications (NSAIDs); certain medications to strengthen the bones including alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), risedronate (Actonel), and tiludronate (Skelid); or oral steroids such as dexamethasone, methylprednisolone (Medrol), or prednisone.
If you experience any of the following symptoms, call your doctor immediately: decreased urination, swelling in the ankles, legs, or feet, excessive tiredness, shortness of breath, confusion, yellowing of the skin or eyes, flu-like symptoms, lack of energy, loss of appetite, pain in the upper right part of the stomach, unusual bruising or bleeding, vomit that is bright red or looks like coffee grounds, bright red blood in stools, or black, tarry stools.
Keep all appointments with your doctor and the laboratory. Your doctor will order laboratory tests before and during your treatment to be sure it is safe for you to take deferasirox and to see if you are developing these serious side effects.
WHY is this medicine prescribed?
Deferasirox is used to remove excess iron in the body in people who have received a large number of blood transfusions. Deferasirox is in a class of medications called iron chelators. It works by attaching to iron in the body so that it can be excreted (removed from the body) in feces.
HOW should this medicine be used?
Deferasirox comes as a tablet for suspension (a tablet to dissolve in liquid) to take by mouth. It should be taken on an empty stomach once a day, at least 30 minutes before eating. Take deferasirox at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take deferasirox exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may adjust your dose of deferasirox at least once every 3 to 6 months, depending on the results of your laboratory tests. Your doctor may also decrease your dose, tell you to stop taking deferasirox for a time or tell you to stop taking the medication completely if the amount of iron in your body decreases or if you experience serious side effects.
Always dissolve the tablets in liquid before you take them. Do not chew or swallow the tablets whole.
To take the tablets for suspension, follow these steps:
Deferasirox removes extra iron from your body slowly over time. Continue to take deferasirox as long as it is prescribed by your doctor. Do not stop taking deferasirox without talking to your doctor.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking deferasirox,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Take the missed dose later in the day, at least 2 hours after your last meal and 30 minutes before eating. However, if it is almost time for the next dose or if you will not be able to take deferasirox on an empty stomach, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Deferasirox may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:
Deferasirox may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include the following:
What OTHER INFORMATION should I know?
Keep all appointments with your doctor. You will need to have hearing and eye exams before starting deferasirox and once a year while taking this medication.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.