What is Ferriprox® (deferiprone)?
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.
What is the most important information I should know about Ferriprox? Approval is based on a reduction in serum ferritin levels. There are no controlled trials demonstrating a direct treatment benefit, such as improvement in disease-related symptoms, functioning, or increased survival.
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) or in children.
Important Safety Information
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.
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 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.
Ferriprox may cause a change in urine color to reddish-brown. This is not harmful and is expected during treatment with Ferriprox.
The most common side effects of Ferriprox include nausea, vomiting, stomach- area (abdominal) pain, and joint pain.
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.
- Ferriprox® (deferiprone) Prescribing Information. Chiesi, May 2020.
- Data on file.
- 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.
- Noetzil LJ, et al. Longitudinal analysis of heart and liver iron in thalassemia major. Blood 2008;112(7):2973-2978.
- Modell B, Khan M, Darlison M, et al. Improved survival of thalassaemia major in the UK and relation to T2* cardiovascular magnetic resonance. J Cardiovasc Magn Reson 2008;10(42). doi:10.1186/1532- 429X-10-42.
- Standards of care guidelines for thalassemia. Children’s Hospital & Research Center Oakland, 2012. Available online at: https://thalassemia.com/documents/SOCGuidelines2012.pdf.
- 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.
- Thalassaemia International Federation. Guidelines for the Management of Transfusion Dependent Thalassaemia (TDT). 3rd edition. Nicosia (CY): Thalassaemia International Federation, 2014. Editors Cappellini MD, Cohen A, Porter J, Taher A, Viprakasit V. Available online at: http://www.ncbi.nlm.nih.gov/ books/NBK269382/.
- 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.
- Jamuar, S and Lai, AHM. Safety and efficacy of iron chelation therapy with deferiprone in patients with transfusion-dependent thalassemia. Ther Adv Hematol 2012;3(5):299-307.
- Binding A, et al. Deferiprone exerts a dose-dependent reduction of liver iron in adults with iron overload. Eur J Haematol 2019;103(2):80-87.
- Ferriprox® (deferiprone) Prescribing Information. Chiesi, April 2020.
©Chiesi USA, Inc. 2020. All rights reserved.
Ferriprox® is a registered trademark of CHIESI FARMACEUTICI S.p.A.
Chiesi Total CareSM is a service mark of CHIESI FARMACEUTICI S.p.A.
PP-G-0376 V3.0 November 2020