Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Ferriprox

Descriptions


Deferiprone is used to remove excess iron from the body in patients with thalassemia, sickle cell disease, or anemia who have blood transfusions.

Deferiprone is an iron chelator (binder). It combines with iron in the blood. The combination of iron and deferiprone is then removed from the body by the kidneys. If you have too much iron in the body, it can damage various organs and tissues.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet
  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of deferiprone tablets in children younger than 8 years of age and deferiprone oral liquid in children younger than 3 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness deferiprone in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Busulfan
  • Diclofenac
  • Exagamglogene Autotemcel
  • Lovotibeglogene Autotemcel
  • Phenylbutazone
  • Probenecid
  • Silymarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood or bone marrow problems (eg, agranulocytosis, neutropenia) or
  • Liver disease—Use with caution. May make these conditions worse.
  • Diamond Blackfan anemia or
  • Myelodysplastic syndrome (bone marrow cancer)—Safety and efficacy have not been established in patients with these conditions.
  • Infection—May decrease your body's ability to fight infection.

Proper Use

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have questions.

If you are taking the oral liquid or tablet 3 times a day: It is best to take the first dose of this medicine in the morning, the second dose at mid-day, and the third dose in the evening with meals unless your doctor tells you otherwise.

If you are taking the tablet 2 times a day: Take the first dose in the morning and the second dose in the evening with food.

Use a marked measuring spoon, oral syringe, or medicine cup to measure the oral liquid.

If you have trouble swallowing the tablet, you may use the oral liquid form of this medicine.

If you are taking antacids, multivitamins, or supplements containing aluminum, iron, and zinc, take these medicines at least 4 hours before or after taking deferiprone.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For chronic iron overload:
    • For oral dosage forms (oral liquid):
      • Adults and children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. At first, 25 milligrams (mg) per kilogram (kg) of body weight, 3 times a day (75 mg per kg per day). Your doctor may adjust your dose as needed. However, the dose is usually not more than 33 mg per kg of body weight, 3 times a day (99 mg per kg per day).
      • Children younger than 3 years of age—Use and dose must be determined by your doctor.
    • For oral dosage forms (1000-mg tablets):
      • Adults and children 8 years of age and older—Dose is based on body weight and must be determined by your doctor. At first, 75 milligrams (mg) per kilogram (kg) of body weight per day, given in 2 or 3 divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 99 mg per kg of body weight per day.
      • Children younger than 8 years of age—Use and dose must be determined by your doctor.
    • For oral dosage forms (500-mg tablets):
      • Adults and children 8 years of age and older—Dose is based on body weight and must be determined by your doctor. At first, 25 milligrams (mg) per kilogram (kg) of body weight, 3 times a day (75 mg per kg per day). Your doctor may adjust your dose as needed. However, the dose is usually not more than 33 mg per kg of body weight, 3 times a day (99 mg per kg per day).
      • Children younger than 8 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store the oral liquid at room temperature for up to 8 weeks. Throw away any unused medicine after 8 weeks.

Keep the bottle tightly closed. Use the tablets dispensed only in its original container.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective birth control to keep from getting pregnant during treatment and for at least 6 months after the last dose of this medicine. Male patients who have female partners who can become pregnant must use an effective birth control during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Deferiprone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Check with your doctor right away if you start to have a cough that will not go away, weight loss, night sweats, a fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

This medicine may cause your urine to turn red or brownish in color. This is normal and is nothing to worry about.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Black, tarry stools
  2. bone pain
  3. chills
  4. cough
  5. fever
  6. lower back or side pain
  7. painful or difficult urination
  8. pale skin
  9. sore throat
  10. ulcers, sores, or white spots in the mouth
  11. unusual bleeding or bruising
  12. unusual tiredness or weakness

Less common

  1. Fever with or without chills
  2. general feeling of tiredness or weakness
  3. hoarseness

Incidence not known

  1. Anxiety
  2. bleeding gums
  3. bloating or swelling of the face, arms, hands, lower legs, or feet
  4. blood in the urine or stools
  5. blurred vision
  6. chest pain, discomfort, or tightness
  7. clay-colored stools
  8. confusion
  9. dark urine
  10. decreased urination
  11. dilated neck veins
  12. dizziness or lightheadedness
  13. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  14. drowsiness
  15. dry mouth
  16. fainting
  17. fast or irregular heartbeat
  18. headache
  19. hives, itching, skin rash
  20. increase in heart rate
  21. increased sweating
  22. irregular breathing
  23. irritation
  24. joint pain, stiffness, or swelling
  25. large, flat, blue or purplish patches in the skin
  26. loss of appetite
  27. muscle tremors
  28. nausea
  29. nervousness
  30. painful knees and ankles
  31. pinpoint red spots on the skin
  32. pounding in the ears
  33. raised red swellings on the skin, the buttocks, legs, or ankles
  34. rapid weight gain
  35. rapid, deep or shallow breathing
  36. redness of the skin
  37. restlessness
  38. seizures
  39. severe nausea or vomiting
  40. slow heartbeat
  41. sneezing
  42. spots on your skin resembling a blister or pimple
  43. stomach pain or cramps
  44. sudden trouble breathing
  45. sugar in the urine
  46. sunken eyes
  47. sweating
  48. swelling of the eyelids, around the eyes, face, lips, hands, or feet
  49. thirst
  50. tingling of the hands or feet
  51. trouble with balance
  52. trouble breathing or swallowing
  53. unpleasant breath odor
  54. unusual weight gain or loss
  55. vision changes
  56. vomiting of blood
  57. weight gain
  58. wrinkled skin
  59. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Difficulty with moving
  2. muscle pain or stiffness
  3. reddish or brown discoloration of the urine
  4. stomach discomfort

Less common

  1. Back pain
  2. belching
  3. diarrhea
  4. heartburn
  5. increased or decreased appetite
  6. indigestion
  7. pain in the arms or legs
  8. stomach upset

Incidence not known

  1. Bloody nose
  2. clenching, gnashing, or grinding teeth
  3. constipation
  4. coughing or spitting up blood
  5. depression
  6. difficulty opening the mouth
  7. difficulty with speaking
  8. drooling
  9. impaired psychomotor skills
  10. increased sensitivity of the skin to sunlight
  11. lockjaw
  12. loss of balance control
  13. muscle spasm, especially of the neck and back
  14. muscle trembling, jerking, or stiffness
  15. pains in the stomach, side, or abdomen, possibly radiating to the back
  16. severe sunburn
  17. shuffling walk
  18. sleepiness or unusual drowsiness
  19. stiffness of the limbs
  20. stomach bloating, burning, cramping, or pain
  21. twisting movements of the body
  22. uncontrolled movements, especially of the face, neck, and back

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.