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FERRIPROX- deferiprone solution


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

Patient Information 

See FDA-Approved Patient Labeling (Medication Guide, Instructions for Use)

  • Instruct patients and their caregivers that FERRIPROX is light sensitive and to store FERRIPROX in the originally supplied bottle and carton. Store FERRIPROX at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature]. Instruct patients and their caregivers to store FERRIPROX out of the sight and reach 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 use the measuring cup provided with FERRIPROX to measure the volume prescribed. Instruct patients to add about 10-15 mL of water to the measuring cup and swirl it around to mix the water with any remaining medicine in the cup and drink the mixture. The measuring cup should be hand-washed with water after use.
  • 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 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.
  • Counsel women of reproductive potential to avoid pregnancy while taking FERRIPROX. Advise patients to immediately notify their physician if they become pregnant, or if they plan to become pregnant during therapy.
  • Inform patients that they should not breast feed while taking FERRIPROX.

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

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 in your blood. 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.

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

Who Should Not Take Ferriprox? 

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

  • Read theInstructions for Usefor detailed instructions.
  • Take FERRIPROX exactly as your healthcare provider tells you. Do not change your dose of FERRIPROX unless your healthcare provider tells you to.
  • Your healthcare provider will tell you how much FERRIPROX to take.
  • Use the measuring cup to measure the amount of FERRIPROX your healthcare provider tells you to take. Note that a teaspoonful (TSP) equals 5 milliliters (mL).
  • 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.
  • You can take FERRIPROX with or without food.
  • 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 at room temperature between 20to 25C (68to 77F).
    • Store in the original bottle and carton to protect from light.
    • After first opening, use a bottle of FERRIPROX oral solution within 35 days. After 35 days, throw away the bottle and any unused medicine that is still in the bottle.

    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: 

purified water, hydroxyethylcellulose, glycerin, hydrochloric acid, artificial cherry flavor, peppermint oil, FD&C Yellow No. 6, and sucralose.

Distributed By: 

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

Manufactured By: 

Apotex Inc., 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.

Issued 05/2017

FERRIPROX(Feh ri prox)

(deferiprone)

oral solution

Read this Instructions for Use before taking FERRIPROX oral solution and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Your healthcare provider will tell you how much FERRIPROX oral solution to take.

Important: 

  • Store FERRIPROX oral solution at room temperature between 20to 25C (68to 77F).
  • Store in the original bottle and carton to protect from light.
  • After first opening, use a bottle of FERRIPROX oral solution within 35 days. After 35 days, throw away the bottle and any unused medicine that is still in the bottle.

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

Supplies needed to prepare and take a dose of FERRIPROX oral solution(See Figure A):

  • 1 bottle of FERRIPROX oral solution
  • 1 measuring cup (supplied with each bottle of FERRIPROX oral solution)

Figure A

figure-a

If you do not receive a measuring cup with your FERRIPROXoral solution, ask your pharmacist. Only use the measuring cup that comes with FERRIPROX oral solution to make sure that you measure the right amount of medicine.

Step 1:To open the bottle of FERRIPROX oral solution, remove the outer plastic wrapper from the child-resistant cap. Push down on the child-resistant cap and turn the cap in the direction of the arrow(See Figure B).

Figure B

figure-b

Step 2:Pour the amount of FERRIPROX oral solution that your healthcare provider tells you to take into the measuring cup provided(See Figure C).

1 teaspoonful (TSP) = 5 milliliters (mL)

Figure C

figure-c

Step 3:Put the child-resistant cap back on the FERRIPROX oral solution bottle and turn it in the direction of the arrow.(See Figure D)

Figure D

figure-d

Step 4:Swallow the measured amount of FERRIPROX oral solution (See Figure E).

Figure E

figure-e

Step 5:Add about 10-15 mL of water to the measuring cup (See Figure F). Gently swirl the measuring cup to mix the water and any FERRIPROX oral solution left in the cup (See Figure G). Drink all the mixture in the measuring cup (See Figure H).

Figure FFigure GFigure H
figure-ffigure-gfigure-h

Step 6:Hand-wash the measuring cup with water.

Step 7:Keep the measuring cup with the bottle of FERRIPROX oral solution.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.



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