deferiprone 1,000 mg tablet, modified release

Generic name:
Deferiprone extended-release (twice a day) - oral

Pronunciation
(de-FER-i-prone)

Brand name(s)
Ferriprox (2 times a day)

This medication may rarely cause a very serious low white blood cell count, which increases your risk of serious, possibly fatal infections. To lower your risk, your doctor will check your blood counts with a blood test before treatment and regularly during treatment. Get medical help right away if you develop any signs of infection such as sore throat that doesn't go away, fever, chills, or flu-like symptoms.

This medication is used by people with certain blood disorders (such as thalassemia, sickle cell anemia) who have too much iron in the body, caused by repeated blood transfusions. Blood transfusions help people with blood disorders but they also bring extra iron into the body. It is important to get rid of the extra iron because high levels of iron can cause health problems (such as heart failure, liver disease, diabetes, delayed growth in children). Deferiprone is used if you have trouble taking other traditional iron-removal medications or you continue to have high iron levels after taking other iron-removal medications.

Deferiprone belongs to a class of drugs known as iron chelators. It works by attaching to iron which helps your body pass the extra iron out in the urine.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking deferiprone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Deferiprone is available in two different formulations: extended-release or immediate-release. Do not switch between the different forms of deferiprone without consulting your doctor. In the US, the extended-release formulation is also called the "twice-a-day" formulation.

Take this medication by mouth with food as directed by your doctor, usually twice daily: once in the morning and once in the evening (about 12 hours apart). Avoid drinking alcoholic beverages. Doing so may change how well the medication works and increase the risk of side effects.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage is based on your medical condition, weight, and response to treatment (including lab test results). To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Your treatment may need to be adjusted or stopped if you develop serious side effects. Follow your doctor's instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Take this medication 4 hours apart from products that may bind to it, decreasing its effectiveness. Ask your pharmacist about the other products you take. Some examples include antacids, vitamins/minerals (such as those containing iron, aluminum, zinc), among others.

See also Warning and How to Use sections.

Nausea, vomiting, stomach/abdominal pain, or joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

This medication may cause your urine to turn a reddish-brown color. This effect is harmless and will disappear when the medication is stopped.

Remember that this medication has been prescribed because your doctor 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.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

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 or at www.fda.gov/medwatch.

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

Before taking deferiprone, 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:

• liver disease
• low white blood cell count

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using deferiprone. Deferiprone may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if deferiprone passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: vision problems, weak muscles, unusual/slowed movements.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, complete blood counts, ferritin/zinc levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. For the tablets that come in a bottle, once the bottle is opened, the tablets expire after 50 days. The tablets that come in a blister pack can be used till the expiration date listed on the packaging. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.