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FERRIPROX- deferiprone tablet, film coated


  1. What Is The Most Important Information I Should Know About Ferriprox?
  2. Stop Taking Ferriprox And Get Medical Help Right Away If You Develop Any Of These Symptoms Of Infection:
  3. What Is Ferriprox?
  4. It Is Not Known If Ferriprox Is Safe And Effective:
  5. Ferriprox Can Cause Serious Side Effects, Including:
  6. Active Ingredients:
  7. Inactive Ingredients:
  8. Distributed By:
  9. Patient Information

What Is The Most Important Information I Should Know About Ferriprox? 

FERRIPROX can cause serious side effects, including a very low white blood cell count. One type of white blood cell that is important for fighting infections is called a neutrophil. If your neutrophil count is low (neutropenia), you may be at risk of developing a serious infection that can lead to death. Neutropenia is common with FERRIPROX and can become severe in some people. Severe neutropenia is known as agranulocytosis. If you develop agranulocytosis, you will be at risk of developing serious infections that can lead to death.

Your healthcare provider should do a blood test before you start FERRIPROX and weekly during treatment to check your neutrophil count. If you develop neutropenia, your healthcare provider should check your blood counts every day until your white blood cell count improves. Your healthcare provider may temporarily stop treatment with FERRIPROX if you develop neutropenia or infection.

Stop Taking Ferriprox And Get Medical Help Right Away If You Develop Any Of These Symptoms Of Infection: 

  • fever
  • sore throat or mouth sores
  • flu-like symptoms
  • chills and severe shaking.

for more information about side effects.

What Is Ferriprox? 

FERRIPROX is a prescription medicine used to treat people with thalassemia syndromes who have iron overload from blood transfusions, when current iron removal (chelation) therapy does not work well enough.

It Is Not Known If Ferriprox Is Safe And Effective: 

  • to treat iron overload due to blood transfusions in people with any other type of anemia that is long lasting (chronic)
  • in children

Do not take FERRIPROX if you are allergic to deferiprone or any of the ingredients in FERRIPROX.

  • Take FERRIPROX exactly as your healthcare provider tells you.
  • Your healthcare provider will prescribe FERRIPROX based on your body weight.
  • Your healthcare provider will check your body iron level during treatment with FERRIPROX and may change your dose if needed. Your healthcare provider may also change your dose of FERRIPROX if you have certain side effects. Do not change your dose of FERRIPROX unless your healthcare provider tells you to.
  • Take FERRIPROX 3 times each day. Take your first dose in the morning, the second dose at mid-day, and the third dose in the evening.
  • Taking FERRIPROX with meals may help reduce nausea.
  • If you must take a medicine to treat indigestion (antacid),or mineral supplements that contain iron, aluminum, or zinc during treatment with FERRIPROX, allow at least 4 hours between taking FERRIPROX and these products.
  • If you take too much FERRIPROX, call your healthcare provider.
  • If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and then continue with your regular schedule. Do not try to catch-up or take 2 doses at the same time to make up for a missed dose.

Ferriprox Can Cause Serious Side Effects, Including: 

    • Store FERRIPROX tablets at room temperature between 68 F to 77 F (20 C to 25 C).
    • Store FERRIPROX tablets in the original bottle and tightly closed to protect from moisture.

    Keep FERRIPROX and all medicines out of the reach of children.

    General information about the safe and effective use of FERRIPROX.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FERRIPROX for a condition for which it was not prescribed. Do not give FERRIPROX to other people, even if they have the same symptoms that you have. It may harm them.

    You can ask your pharmacist or healthcare provider for information about FERRIPROX that is written for health professionals.

Active Ingredients: 

deferiprone

Inactive Ingredients: 

Tablet core: methylcellulose, crospovidone, and magnesium stearate.

Coating: hypromellose, hydroxypropyl cellulose, macrogol, and titanium dioxide.

Distributed By: 

ApoPharma USA, Inc., Weston, FL, United States of America, 33326.

Manufactured by: ApotexInc., Toronto, Ontario, Canada, M9L 1T9.

For more information, call 1-866-949-0995.



This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 08/2019

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide)

  • Instruct patients and their caregivers to store FERRIPROX in the originally supplied bottle, closed tightly to protect from moisture. Store at 20 C to 25 C (68 F to 77 F); excursions permitted to 15 C to 30 C (59 F to 86 F) [see USP Controlled Room Temperature]. Instruct patients and their caregivers to store FERRIPROX out of the reach and sight of children.
  • Inform patients of the risks of developing agranulocytosis and instruct them to immediately interrupt therapy and report to their physician if they experience any symptoms of infection such as fever, sore throat or flu-like symptoms.
  • Advise patients that the amount of FERRIPROX prescribed is based on body weight and on the therapeutic goal (reduction or stabilization of the body iron load).
  • Advise patients to take the first dose of FERRIPROX in the morning, the second dose at midday, and the third dose in the evening. Clinical experience suggests that taking FERRIPROX with meals may reduce nausea. If a dose of this medicine has been missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not catch-up or double doses.
  • Advise patients to contact their physician in the event of overdose.
  • Inform patients that their urine might show a reddish/brown discoloration due to the excretion of the iron-deferiprone complex. This is a very common sign of the desired effect of FERRIPROX, and it is not harmful.
  • Advise females of reproductive potential to use effective contraception during treatment with FERRIPROX and to immediately notify their physician if they become pregnant.
  • Six months of contraception is recommended after cessation of therapy for females of reproductive potential. Three months of contraception is recommended after cessation of therapy for males of reproductive potential.
  • Inform patients that they should not breastfeed while taking FERRIPROX.

Distributed by ApoPharma USA, Inc., Weston, FL, United States of America, 33326. Manufactured by Apotex Inc., Toronto, Ontario, Canada, M9L 1T9.



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