Deferiprone

IMPORTANT WARNING:

Deferiprone may cause a decrease in the number of white blood cells made by your bone marrow. White blood cells help your body fight infection, so if you have a low number of white blood cells, there is a higher risk that you will develop a serious or life-threatening infection. Tell your doctor about all the medications you are taking, because taking certain other medications along with deferiprone may increase the risk that your white blood cell count will decrease. If you experience any of the following symptoms of infection, stop taking deferiprone and call your doctor immediately or get emergency medical help: fever, sore throat, mouth sores, flu-like symptoms, chills, or severe shaking.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain laboratory tests, including tests to check your white blood cell count before your treatment and at least once weekly during your treatment.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with deferiprone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risk(s) of taking deferiprone.

WHY is this medicine prescribed?

Deferiprone is used to remove excess iron in the body in adults and children 3 years of age and older who have thalassemia (an inherited condition that causes a low number of red blood cells). It is also used to remove excess iron in adults and children 3 years of age and older with sickle cell disease (an inherited blood disease) or other types of anemia (a lower than normal number of red blood cells). Deferiprone 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).

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Deferiprone comes as a tablet and as an oral solution (liquid) to take by mouth. It is usually taken two or three times daily. Deferiprone may be taken with or without food, but taking it with meals may help to prevent nausea and vomiting that may be caused by the medication. Take deferiprone at around the same time(s) 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 deferiprone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If your dose includes half of a tablet, split a tablet carefully on the score mark.

Use the measuring cup provided with the solution to measure your dose. Add your dose to the provided measuring cup and drink it. Then, add 2 to 3 teaspoons (10 to 15 mL) of water to the measuring cup, gently swirl it around to mix the water with any remaining medication in the cup, and drink the mixture. Hand wash the measuring cup with water after use.

Your doctor may adjust your dose of deferiprone every 2 to 3 months depending on your laboratory test results.

What SPECIAL PRECAUTIONS should I follow?

Before taking deferiprone,

• tell your doctor and pharmacist if you are allergic to deferiprone, any other medications, or any of the ingredients in deferiprone tablets or oral solution. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• if you are taking antacids, multivitamins, or iron or zinc supplements, take them 4 hours before or 4 hours after you take deferiprone.

• tell your doctor what herbal products you are taking, especially milk thistle.

• tell your doctor if you have or have ever had liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are receiving deferiprone. If you are a woman who is able to become pregnant, you must take a pregnancy test before starting treatment and use effective birth control during your treatment and for 6 months after your final dose. If you are male, you and your female partner should use birth control during your treatment and for 3 months after your final dose. If you become pregnant while taking deferiprone, call your doctor immediately. Deferiprone may harm the fetus.

• tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed during your treatment and for 2 weeks after your final dose.

• avoid alcoholic beverages while you are taking deferiprone. Alcohol can make the side effects from deferiprone worse.

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 as soon as you remember it. However, if it is almost time for the next dose, 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?

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

• nausea
• vomiting
• heartburn
• stomach pain
• diarrhea
• increased or decreased appetite
• weight gain
• pain in the arms, legs, back or joints
• headache
• red or brown discoloration of urine

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• reddish purple spots or rash, especially on the lower half of the body; swollen and sore joints; stomach pain, or bloody urine
• hives
• swelling around the eyes
• fast or pounding heartbeat

Deferiprone may cause other side effects. Call your doctor if you have any unusual problems while you are 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 (http://www.fda.gov/Safety/MedWatch) 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 light, excess heat and moisture (not in the bathroom). After first opening the oral solution bottle, discard it and any unused oral solution after 35 days.

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

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.

What should I do in case of OVERDOSE?

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.

Symptoms of overdose may include:

• double vision
• uncontrollable eye movements
• unusual, slowed, or uncontrollable movements of any part of the body

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order lab tests to check your body's response to deferiprone.

Your urine may turn a red or brown color; this effect is common and not harmful.

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.