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As iron continues to build up in the body, complications happen more often.1

Reducing iron overload in the heart is critical for people with thalassemia syndromes

heart problems heart problems heart problems

Adapted from Borgna-Pignatti et al., 20042

When iron is removed from the heart, heart function improves, and risk of heart failure drops3

Based on a total of 1,073 patients diagnosed with thalassemia major before the age of 3.

Iron Monitoring In Thalassemia

Appropriate iron chelation, at the appropriate dosing level, removes extra iron from the body and organs to help minimize damage caused by iron overload1,6

Appropriate chelation therapy Appropriate chelation therapy Appropriate chelation therapy

Ferriprox has not been proven to reduce certain clinical outcomes. Please see the efficacy section to understand the role Ferriprox plays in disease management.

Lowering serum ferritin and liver iron concentration are not enough. Reducing cardiac iron is the priority in thalassemia.

Thalassemia Safety Chart Thalassemia Safety Chart Thalassemia Safety Chart

§MRI=magnetic resonance imaging

IMPORTANT SAFETY INFORMATION

What is Ferriprox® (deferiprone)?

Ferriprox® (deferiprone) is a prescription medicine used to treat iron overload from blood transfusions in people with:1

  • thalassemia syndromes
  • sickle cell disease or other anemias

Ferriprox Tablets are for adults and children ≥8 years of age; Ferriprox Oral Solution is for patients ≥3 years of age.

It is not known if Ferriprox 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

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, or chills and severe shaking.

What is Ferriprox® (deferiprone)?

Ferriprox® (deferiprone) is a prescription medicine used to treat iron overload from blood transfusions in people with:1

  • thalassemia syndromes
  • sickle cell disease or other anemias

Ferriprox Tablets are for adults and children ≥8 years of age; Ferriprox Oral Solution is for patients ≥3 years of age.

It is not known if Ferriprox 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

Important Safety Information

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

Before you take Ferriprox, tell your healthcare provider about all of your medical conditions, including if you: have liver problems, are pregnant or plan to become pregnant. Ferriprox can harm your unborn baby. You should avoid becoming pregnant during treatment with Ferriprox. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Ferriprox. For females who are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Ferriprox. You should use effective birth control during treatment with Ferriprox and for at least 6 months after the last dose. For males with female partners who are able to become pregnant, you should use effective birth control during treatment with Ferriprox and for at least 3 months after the last dose. Talk to your doctor if you are breastfeeding or plan to breastfeed. It is not known if Ferriprox passes into your breast milk. Do not breastfeed during treatment with Ferriprox and for at least 2 weeks after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Avoid drinking alcohol during treatment with Ferriprox tablets (2 times a day). This may cause a faster release of the medicine.

What are other possible side effects of Ferriprox?

Ferriprox can cause serious side effects, including increased liver enzyme levels in your blood. Your healthcare provider should do monthly blood tests to check your liver function during treatment with Ferriprox.

Ferriprox can cause decreased levels of zinc in your blood. Your healthcare provider will do blood tests to check your zinc levels during treatment with Ferriprox and may prescribe a zinc supplement for you if your zinc levels are low.

The most common side effects of Ferriprox in people with thalassemia include nausea, vomiting, stomach-area (abdominal) pain, joint pain, abnormal liver function tests and low white blood cells.

The most common side effects of Ferriprox in people with sickle cell disease or other anemias include fever, stomach-area (abdominal) pain, bone pain, headache, vomiting, pain in arms or legs, sickle cell anemia with crisis, back pain, abnormal liver function tests, joint pain, mouth and throat pain, common cold, low white blood cells, cough and nausea.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

Please see Full Prescribing Information, including boxed WARNING, and Medication Guide.

IMPORTANT SAFETY INFORMATION

What is Ferriprox® (deferiprone)?

Ferriprox® (deferiprone) is a prescription medicine used to treat iron overload from blood transfusions in people with:1

  • thalassemia syndromes
  • sickle cell disease or other anemias

Ferriprox Tablets are for adults and children ≥8 years of age; Ferriprox Oral Solution is for patients ≥3 years of age.

It is not known if Ferriprox 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

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, or chills and severe shaking.

What is Ferriprox® (deferiprone)?

Ferriprox® (deferiprone) is a prescription medicine used to treat iron overload from blood transfusions in people with:1

  • thalassemia syndromes
  • sickle cell disease or other anemias

Ferriprox Tablets are for adults and children ≥8 years of age; Ferriprox Oral Solution is for patients ≥3 years of age.

It is not known if Ferriprox 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

Important Safety Information

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

Before you take Ferriprox, tell your healthcare provider about all of your medical conditions, including if you: have liver problems, are pregnant or plan to become pregnant. Ferriprox can harm your unborn baby. You should avoid becoming pregnant during treatment with Ferriprox. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Ferriprox. For females who are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Ferriprox. You should use effective birth control during treatment with Ferriprox and for at least 6 months after the last dose. For males with female partners who are able to become pregnant, you should use effective birth control during treatment with Ferriprox and for at least 3 months after the last dose. Talk to your doctor if you are breastfeeding or plan to breastfeed. It is not known if Ferriprox passes into your breast milk. Do not breastfeed during treatment with Ferriprox and for at least 2 weeks after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Avoid drinking alcohol during treatment with Ferriprox tablets (2 times a day). This may cause a faster release of the medicine.

What are other possible side effects of Ferriprox?

Ferriprox can cause serious side effects, including increased liver enzyme levels in your blood. Your healthcare provider should do monthly blood tests to check your liver function during treatment with Ferriprox.

Ferriprox can cause decreased levels of zinc in your blood. Your healthcare provider will do blood tests to check your zinc levels during treatment with Ferriprox and may prescribe a zinc supplement for you if your zinc levels are low.

The most common side effects of Ferriprox in people with thalassemia include nausea, vomiting, stomach-area (abdominal) pain, joint pain, abnormal liver function tests and low white blood cells.

The most common side effects of Ferriprox in people with sickle cell disease or other anemias include fever, stomach-area (abdominal) pain, bone pain, headache, vomiting, pain in arms or legs, sickle cell anemia with crisis, back pain, abnormal liver function tests, joint pain, mouth and throat pain, common cold, low white blood cells, cough and nausea.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

Please see Full Prescribing Information, including boxed WARNING, and Medication Guide.

References: 1. Coates TD, Wood JC. How we manage iron overload in sickle cell people. Br. J Haematol 2017;177(5):703-16. 2. Borgna-Pignatti C, et al. Survival and complications in patients with thalassemia major treated with transfusion and deferoxamine. Haematologica 2004;89:1187-1193. 3. Pennell DJ, et al. On improvement in ejection fraction with iron chelation in thalassemia major and the risk of future heart failure. J Cardiovasc Magn Reson 2011;13:45. 4. United Kingdom Thalassaemia Society. Standards for the Clinical Care of Children and Adults with Thalassaemia in the UK. 3rd edition; 2016. Editors Yardumian A, Telfer P, Shah F, et al. Available online at: https://ukts.org/wp-content/uploads/2019/12/Standards-2016final.pdf. 5. Pennell DJ, et al. Cardiovascular function and treatment in ß-thalassemia major: a consensus statement from the American Heart Association. Circulation 2013;128(3):281-308. 6. Beris P. Transfusion and iron overload: Where are the risks? Haema 2019;10(1):29-38. 7. Coates TD. Physiology and pathophysiology of iron in hemoglobin-associated diseases. Free Radic Biol Med 2014;72:23-40. 8. Coates TD, Carson S et al. Management of iron overload in hemoglobinopathies: what is the appropriate target iron level? Ann NY Acad Sci 2016; 95-106. 9. Standards of care guidelines for thalassemia. Children’s Hospital & Research Center Oakland. 2012. Available online at: https://thalassemia.com/documents/SOCGuidelines2012.pdf. 10. Sheth S. Monitoring of iron overload in transfusion-dependent thalassemia (TDT). Cooley’s Anemia Foundation. Accessed online October 10, 2019 at: https://thalassemia.com/documents/monitoring-iron-overload-in-transfusion-dependent-thalassemia.pdf.

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