Exjade (Deferasirox)

(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.

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.

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.

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.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking deferasirox, call your doctor.
• 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.

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

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.

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.

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). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.