Ferriprox binds to iron and removes it from the bloodstream.

Ferriprox is used to treat iron overload caused by blood transfusions in people with thalassemia syndrome or sickle cell disease, which are hereditary red blood cell disorders.

Ferriprox may also be used for purposes not listed in this medication guide.

Do not use Ferriprox if you are pregnant. It could harm the unborn baby. Both men and women using this medicine should use effective birth control. Women should keep using birth control for at least 6 months after the last dose. Men should keep using birth control for at least 3 months after the last dose.

Stop using Ferriprox and call your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, skin sores, or sores in your mouth and throat.

Before taking this medicine

You should not use Ferriprox if you are allergic to deferiprone.

To make sure Ferriprox is safe for you, tell your doctor if you have ever had:

• liver disease; or

• a weak immune system.

It is not known whether deferiprone will harm an unborn baby. Both men and women using this medicine should use effective birth control to prevent pregnancy.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Ferriprox.

You should not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Ferriprox tablets are used in adults and children 8 years of age and older.
Ferriprox Oral Solution is used in adults and children 3 years of age and older.

Take Ferriprox exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

There are two types of Ferriprox tablets that are taken on different schedules, either 2 times a day, or 3 times a day. Be sure you are taking the correct tablet and ask your healthcare provider if unsure.

If you are taking the tablets twice a day, take the first dose in the morning and the second dose in the evening, about 12 hours apart.

If you are taking the tablets three times a day, take the first dose each morning, the second dose at mid-day, and the third dose in the evening.

Measure liquid medicine (oral solution) carefully. Use only the dose-measuring cup provided with the oral solution. Drink all of the medicine in the measuring cup. Then add about 1 tablespoon of water to the cup, swirl gently and drink. Hand-wash the measuring cup after each use.

Take with food if Ferriprox upsets your stomach.

You will need frequent medical tests, and your next dose may be delayed based on the results.

Deferiprone doses are based on weight. Your dose needs may change if you gain or lose weight.

Store Ferriprox tablets or liquid in the original container at room temperature. Protect from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Throw away any liquid medicine not used within 35 days after you first opened the bottle.

Usual Adult and Pediatric Dose for Iron Overload:

Ferriprox Tablets are available in two different 1000 mg formulations, which have different dosing regimens to achieve the same total daily dosage. To prevent medication errors, before prescribing and dispensing, ensure that the tablet formulation is appropriate for the dosing regimen. Each tablet has distinct identifying characteristics.

Ferriprox Tablets (three times a day):
- Starting oral dosage: 75 mg/kg/day (actual body weight) in three divided doses
- Maximum oral dosage: 99 mg/kg/day (actual body weight) in three divided doses
- Round dose to the nearest 500 mg (half-tablet). 

Uses:
Treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes.
Treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with sickle cell disease or other anemias.

Ferriprox Tablets (twice a day):
- Starting oral dosage: 75 mg/kg/day (actual body weight) in two divided doses
- Maximum oral dosage: 99 mg/kg/day (actual body weight) in two divided doses
- Round the total daily dose to the nearest 500 mg (half-tablet).

Uses:
Treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes.
Treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with sickle cell disease or other anemias.

Ferriprox Oral Solution 80 mg/mL:
- Starting oral dosage: 75 mg/kg/day (actual body weight) in three divided doses
- Maximum oral dosage: 99 mg/kg/day (actual body weight) in three divided doses
- Round dose to the nearest 2.5 mL.

Uses:
Treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes.
Treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with sickle cell disease or other anemias.

Tailor dose to patient response and therapeutic goals (maintenance or reduction of iron burden).

You should not use Ferriprox if you are allergic to deferiprone.

To make sure Ferriprox is safe for you, tell your doctor if you have ever had:

• liver disease; or

• a weak immune system.

It is not known whether deferiprone will harm an unborn baby. Both men and women using this medicine should use effective birth control to prevent pregnancy.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Ferriprox.

You should not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Ferriprox tablets are used in adults and children 8 years of age and older.
Ferriprox Oral Solution is used in adults and children 3 years of age and older.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not use other iron chelating medicines such as deferasirox (Exjade) or deferoxamine (Desferal), unless your doctor has told you to.

Get emergency medical help if you have signs of an allergic reaction to Ferriprox: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Ferriprox. Stop using this medicine and call your doctor right away if you have signs of infection such as:

• fever, chills, body aches;

• flu symptoms;

• skin sores; or

• sores in your mouth and throat.

Further doses may be delayed until your infection clears up.

Ferriprox may cause your urine to turn a reddish-brown color. This side effect is usually not harmful. Call your doctor if you also have upper stomach pain, clay-colored stools, or jaundice (yellowing of your skin or the whites of your eyes).

Common Ferriprox side effects may include:

• nausea, vomiting, stomach pain;

• infections;

• joint pain; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you take any of the following medicines, take your Ferriprox dose 4 hours before or 4 hours after you take the other medicine:

• an antiacid that contains aluminum;

• a medicine or supplement that contains iron (including ferric citrate, Feosol, Fergon, Ferrocite, Hemocyte, and others; or

• vitamin or mineral supplements that contain iron or zinc.

Avoid taking an herbal supplement containing milk thistle.

Other drugs may interact with deferiprone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.