Deferasirox

Conditions Treated

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.

Possible Side Effects

What Side Effects Can This Cause?

Deferasirox may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• stomach pain
• nausea
• vomiting
• diarrhea

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:

• hearing loss
• vision problems
• hives
• rash
• blisters
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness

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 http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication 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:

If you are taking less than 1000 mg of deferasirox, fill a cup halfway (about 3.5 oz/100 mL) with water, apple juice, or orange juice. If you are taking more than 1000 mg of deferasirox, fill a cup (about 7 oz/200 mL) with water, apple juice, or orange juice. If you are not sure how much deferasirox you are to take, ask your doctor or pharmacist.

Place the number of tablets your doctor has told you to take in the cup.

Stir the liquid for 3 minutes to completely dissolve the tablets.The mixture may become thick as you stir it.

Drink the liquid immediately.

Add a small amount of liquid to the empty cup and stir. Swish the cup to dissolve any medication that is still in the glass or on the stirrer.

Drink the rest of the liquid.

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.

What Dietary Instructions Should I Follow

Unless your doctor tells you otherwise, continue your normal diet.

Are There Any Special Instructions

Before taking deferasirox, tell your doctor and pharmacist if you are allergic to deferasirox, any other medications, or any of the ingredients in deferasirox tablets. Ask your doctor or pharmacist for a list of the ingredients. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: cholestyramine (Locholest, Questran, Prevalite), cyclosporine (Gengraf, Neoral, Sandimmune), hormonal contraceptives (birth control pills, patches, rings, or injections), other medications to remove excess iron from the body, paclitaxel (Abraxane, Taxol), phenytoin, phenobarbital, repaglinide (Prandin, in Prandimet), rifampin (Rimactane, Rifadin, in Rifamate, in Rifater), ritonavir (Norvir), and simvastatin (Zocor, in Simcor, in Vytorin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. if you are taking aluminum-containing antacids such as Amphogel, Alternagel, Gaviscon, Maalox, or Mylanta, take them 2 hours before or after deferasirox. tell your doctor if you have an infection or severe nausea, vomiting, or diarrhea, or if you think you may be dehydrated. Also tell your doctor if you have or have ever had hearing, ear, or vision problems. you should know that deferasirox may make you dizzy. Do not drive a car or operate machinery until you know how this medication affects you. tell your doctor if you develop diarrhea or vomiting during your treatment. If you have these symptoms, it is important to drink plenty of fluid so you will not become dehydrated.