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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.

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