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Transfusional iron overload impacts outcomes associated with sickle cell disease1,2

As iron builds up in the body, complications happen more often.3

A review of clinical trials from 2018 found that people with sickle cell disease with iron overload had higher rates of:

heart

DEATH 64% compared to 5% for those without iron overload1†

liver

ORGAN FAILURE 71% compared to 19% for those without iron overload1†

pain

PAIN EPISODES64% experienced ≥3 pain episodes per year compared to 38% for those without iron overload1†

Another clinical study in 199 transfused people with sickle cell disease compared to 64 non-transfused people with sickle cell disease also showed an increase in the number of:

hospital

HOSPITAL STAYS 4.1hospitalizations per year compared to 2.1 for non-transfused people (p<0.001)2‡

lifeline

DEATHS 17

The death rate in adults with sickle cell disease who receive transfusions is 3 times higher than the general US population.2‡

Ferriprox has not been proven to impact outcomes such as death, organ function, or symptoms such as pain episodes.

Iron chelation therapy is most beneficial when it is started early and taken as prescribed1‡

Defined as serum ferritin levels >1500 ng/mL and transferrin saturation >50%. Without iron overload was defined as serum ferritin levels <100 and transferrin saturation <50%.1

Based on a study of people who were either currently on or had received regular transfusion therapy and confirmed to have iron overload as defined by a liver iron concentration (LIC) of >10 mg/g dry weight or 3 serum ferritin values that averaged ≥2,000 ng/mL within the previous 12 months. 142 people with thalassemia and 199 people with sickle cell disease who received regular transfusions were included in the study group and 64 people with sickle cell disease who did not receive transfusions were selected as controls.

Iron Monitoring In Sickle Cell Disease

Appropriate iron chelation, at the appropriate dosing level, removes extra iron from the body and organs to help minimize damage caused by iron overload1,5

Goals of appropriate chelation therapy:6,7

Bind and remove excess iron that has accumulated and minimize free iron uptake into tissues

Remove iron that has accumulated in the body and organs

thalesemia thalesemia thalesemia

Treatment guidelines support regular monitoring of serum ferritin, and MRI T2* of the heart and liver.1,8

Ferriprox has not been proven to impact outcomes such as death and organ damage in sickle cell patients.

Depending on the organ, it can take a long time to reduce iron – so treatment guidelines recommend preventing significant iron loading from the start.1

Tranfussion Target Chart Tranfussion Target Chart Tranfussion Target 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. Ballas SK et al. The effect of iron chelation therapy on overall survival in sickle cell disease and ß-thalassemia: A systematic review. Am J Hematol 2018;93:943-52. 2. Coates TD, Wood JC. How we manage iron overload in sickle cell people. Br. J Haematol 2017;177(5):703-16. 3. Fung EB, et al. Morbidity and mortality in chronically transfused subjects with thalassemia and sickle cell disease: A report from the multi-center study of iron overload. Am J Hematol 2007;82:255-65. 4. Sundaram N, Bennett M, Wilhelm J et al. Biomarkers for early detection of sickle nephropathy. Am J Hematol 2011;86(7):559-66. 5.Beris P. Transfusion and iron overload: Wher are the risks? Haema 2019;10(1):29-38. 6. Coates TD. Physiology and pathophysiology of iron in hemoglobin-associated diseases. Free Radic Biol Med 2014;72:23-40. 7. 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. 8. Chou ST et al. American Society of Hematology 2020 guidelines for sickle cell disease: transfusion support. Blood 2020;4(2):327-55.

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