Medication Guide
FERRIPROX (Feh ri prox) Oral Solution
(deferiprone)
oral solution, for oral use
100 mg/mL |
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What is the most important information I should know about FERRIPROX Oral Solution?
FERRIPROX Oral Solution 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 Oral Solution 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 will do a blood test before you start FERRIPROX Oral Solution and regularly 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 Oral Solution if you develop neutropenia or infection.
Stop taking FERRIPROX Oral Solution and call your healthcare provider or 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
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It is important for you to have your white blood cell count checked within 24 hours of developing symptoms of an infection to see if you have severe neutropenia (agranulocytosis). Do not delay getting medical care if you are unable to reach your healthcare provider.
See “What are the possible side effects of FERRIPROX Oral Solution?” for more information about side effects.
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What is FERRIPROX Oral Solution?
FERRIPROX Oral Solution is a prescription medicine used to treat iron overload from blood transfusions in adults and children 3 years of age and older with:
- thalassemia syndromes.
- sickle cell disease or other anemias.
It is not known if FERRIPROX Oral Solution is safe and effective to treat iron overload due to blood transfusions:
- in people with myelodysplastic syndrome or Diamond Blackfan anemia
- in children less than 3 years of age
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| Do not take FERRIPROX Oral Solution if you are allergic to deferiprone or any of the ingredients in FERRIPROX Oral Solution. See the end of this Medication Guide for a complete list of ingredients in FERRIPROX Oral Solution.
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Before taking FERRIPROX Oral Solution, tell your healthcare provider about all of your medical conditions, including if you:
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| Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
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How should I take FERRIPROX Oral Solution?
Read the Instructions for Use for detailed instructions about how to measure and take a dose of FERRIPROX Oral Solution.
- Take FERRIPROX Oral Solution exactly as your healthcare provider tells you.
- Your healthcare provider will prescribe FERRIPROX Oral Solution based on your body weight.
- Your healthcare provider will check your body iron level during treatment with FERRIPROX Oral Solution and may change your dose if needed. Your healthcare provider may also change your dose of FERRIPROX Oral Solution if you have certain side effects. Do not change your dose of FERRIPROX Oral Solution unless your healthcare provider tells you to.
- Use the measuring cup that comes with FERRIPROX Oral Solution to measure your prescribed dose.
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Take FERRIPROX Oral Solution 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 Oral Solution with meals may help reduce nausea.
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If you must take a medicine to treat indigestion (antacid), or supplements that contain iron, aluminum, or zinc during treatment with FERRIPROX Oral Solution, allow at least 4 hours between taking FERRIPROX Oral Solution and these products.
- If you take too much FERRIPROX Oral Solution, 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.
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What are the possible side effects of FERRIPROX Oral Solution?
FERRIPROX Oral Solution can cause serious side effects, including:
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See “What is the most important information I should know about FERRIPROX Oral Solution?”
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Increased liver enzyme levels in your blood. Your healthcare provider should do blood tests to check your liver function before you start and then monthly during treatment with FERRIPROX Oral Solution. Your healthcare provider may temporarily stop treatment with FERRIPROX Oral Solution if you develop increased liver enzyme levels and they continue to be increased.
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Decreased levels of zinc in your blood. Your healthcare provider will do blood tests to check your zinc levels before you start and during treatment with FERRIPROX Oral Solution, and may prescribe a zinc supplement for you if your zinc levels are low.
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The most common side effects of FERRIPROX Oral Solution in people with thalassemia include:
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- vomiting
- abnormal liver function tests
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- stomach-area (abdominal) pain
- low white blood cells
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| The most common side effects of FERRIPROX Oral Solution in people with sickle cell disease or other anemias include: |
- fever
- headache
- sickle cell anemia with crisis
- joint pain
- low white blood cells
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- stomach-area (abdominal) pain
- vomiting
- back pain
- mouth and throat pain
- cough
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- bone pain
- pain in arms or legs
- abnormal liver function tests
- common cold
- nausea
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FERRIPROX Oral Solution may cause a change in urine color to reddish-brown. This is not harmful and is expected during treatment with FERRIPROX Oral Solution.
These are not all of the possible side effects of FERRIPROX Oral Solution.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store FERRIPROX Oral Solution?
- Store FERRIPROX Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C).
- Store FERRIPROX Oral Solution 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, discard the bottle and any unused FERRIPROX Oral Solution.
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| Keep FERRIPROX Oral Solution and all medicines out of the reach of children. |
General information about the safe and effective use of FERRIPROX Oral Solution.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FERRIPROX Oral Solution for a condition for which it was not prescribed. Do not give FERRIPROX Oral Solution 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 Oral Solution that is written for health professionals.
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What are the ingredients in FERRIPROX Oral Solution?
Active ingredient: deferiprone
Inactive ingredients: purified water, hydroxyethylcellulose, glycerin, hydrochloric acid, artificial cherry flavor, peppermint oil, FD&C Yellow No. 6, and sucralose.
Distributed by: Chiesi USA, Inc., Cary, NC 27518.
Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9.
CTFD-016-0521-02-SPL
For more information, call 1-888-661-9260.
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