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Treatment with regular blood transfusions results in iron accumulation which can damage the liver, endocrine system, and heart.1

Patients receiving chronic transfusions acquire more iron that can be bound by transferrin and become overloaded2,3

liver endocrine liver endocrine liver endocrine

NTBI is absorbed into each organ independently1

An important aspect of chelation in preventing iron-induced damage is the removal of non–transferrin-bound iron from plasma.1

As iron continues to build up in the body, complications happen more often.4

heart problems heart problems heart problems

Adapted from Borgna-pignatti et al.,2004

Cardiac-related mortality is the leading cause of death in the thalassemia major population5

  • When iron is removed, LVEF can improve and risk of heart failure is reduced6

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

Consider renal/hepatic toxicity

Regular monitoring of both renal and hepatic toxicity can help optimize chelation and ensure patients are on an appropriate chelator.7

Iron monitoring in thalassemia

If removal of NTBI can be achieved, complications of iron overload may be reduced or eliminated4

iron chelation iron chelation iron chelation

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

Thalassemia treatment guidelines support regular monitoring of serum ferritin, and cardiac and liver MRI T2*7,10,11

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

thalassemia thalassemia thalassemia

MRI=magnetic resource imaging

IMPORTANT SAFETY INFORMATION

Indication

Ferriprox® (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload due to:1

  • thalassemia syndromes
  • sickle cell disease or other anemias

Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age; Ferriprox Oral Solution is indicated in patients ≥3 years of age.

Limitations of Use

Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.

Important Safety Information

WARNING: AGRANULOCYTOSIS AND NEUTROPENIA

  • Ferriprox can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis.
  • Measure the absolute neutrophil count (ANC) before starting Ferriprox and monitor weekly while on therapy.
  • Interrupt Ferriprox if infection develops and monitor the ANC more frequently.
  • Advise patients taking Ferriprox to report immediately any symptoms indicative of infection.

Indication

Ferriprox® (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload due to:1

  • thalassemia syndromes
  • sickle cell disease or other anemias

Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age; Ferriprox Oral Solution is indicated in patients ≥3 years of age.

Limitations of Use

Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.

Important Safety Information

Ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations.

In pooled clinical trials, 7.5% of 642 patients with thalassemia syndromes treated with Ferriprox developed increased ALT values. Four (0.62%) Ferriprox-treated subjects discontinued the drug due to increased serum ALT levels and 1 (0.16%) due to an increase in both ALT and AST. In pooled clinical trials, 7.7% of 196 patients with sickle cell disease or other anemias treated with Ferriprox developed increased ALT values. Monitor serum ALT values monthly during therapy with Ferriprox and consider interruption of therapy if there is a persistent increase in the serum transaminase levels. Decreased plasma zinc concentrations have been observed on deferiprone therapy. Monitor plasma zinc, and supplement in the event of a deficiency.

Ferriprox can cause fetal harm. Advise females of reproductive potential to use an effective method of contraception during treatment with Ferriprox and for at least six months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Ferriprox and for at least three months after the last dose. Advise females not to breastfeed during treatment with Ferriprox and for at least 2 weeks after the last dose.

Avoid co-administration of Ferriprox with other drugs known to be associated with neutropenia or agranulocytosis; however, if this is unavoidable, closely monitor the absolute neutrophil count. Avoid co-administration with UGT1A6 inhibitors. Allow at least a 4-hour interval between administration of Ferriprox and drugs or supplements containing polyvalent cations (e.g., iron, aluminum, or zinc).

The most common adverse reactions in patients with thalassemia (incidence ≥6%) are nausea, vomiting, abdominal pain, arthralgia, ALT increased and neutropenia. The most common adverse reactions in patients with sickle cell disease or other anemias (incidence ≥6%) are pyrexia, abdominal pain, bone pain, headache, vomiting, pain in extremity, sickle cell anemia with crisis, back pain, ALT increased, AST increased, arthralgia, oropharyngeal pain, nasopharyngitis, neutrophil count decreased, cough and nausea.

Inform patients that their urine might show a reddish/brown discoloration due to the excretion of the iron-deferiprone complex. This is a very common sign of the desired effect, and it is not harmful.

Advise patients to avoid alcohol while taking Ferriprox tablets (twice-a-day). Consumption of alcohol while taking Ferriprox tablets (twice-a-day) may result in more rapid release of deferiprone.

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

IMPORTANT SAFETY INFORMATION

Indication

Ferriprox® (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload due to:1

  • thalassemia syndromes
  • sickle cell disease or other anemias

Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age; Ferriprox Oral Solution is indicated in patients ≥3 years of age.

Limitations of Use

Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.

Important Safety Information

WARNING: AGRANULOCYTOSIS AND NEUTROPENIA

  • Ferriprox can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis.
  • Measure the absolute neutrophil count (ANC) before starting Ferriprox and monitor weekly while on therapy.
  • Interrupt Ferriprox if infection develops and monitor the ANC more frequently.
  • Advise patients taking Ferriprox to report immediately any symptoms indicative of infection.

Indication

Ferriprox® (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload due to:1

  • thalassemia syndromes
  • sickle cell disease or other anemias

Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age; Ferriprox Oral Solution is indicated in patients ≥3 years of age.

Limitations of Use

Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.

Important Safety Information

Ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations.

In pooled clinical trials, 7.5% of 642 patients with thalassemia syndromes treated with Ferriprox developed increased ALT values. Four (0.62%) Ferriprox-treated subjects discontinued the drug due to increased serum ALT levels and 1 (0.16%) due to an increase in both ALT and AST. In pooled clinical trials, 7.7% of 196 patients with sickle cell disease or other anemias treated with Ferriprox developed increased ALT values. Monitor serum ALT values monthly during therapy with Ferriprox and consider interruption of therapy if there is a persistent increase in the serum transaminase levels. Decreased plasma zinc concentrations have been observed on deferiprone therapy. Monitor plasma zinc, and supplement in the event of a deficiency.

Ferriprox can cause fetal harm. Advise females of reproductive potential to use an effective method of contraception during treatment with Ferriprox and for at least six months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Ferriprox and for at least three months after the last dose. Advise females not to breastfeed during treatment with Ferriprox and for at least 2 weeks after the last dose.

Avoid co-administration of Ferriprox with other drugs known to be associated with neutropenia or agranulocytosis; however, if this is unavoidable, closely monitor the absolute neutrophil count. Avoid co-administration with UGT1A6 inhibitors. Allow at least a 4-hour interval between administration of Ferriprox and drugs or supplements containing polyvalent cations (e.g., iron, aluminum, or zinc).

The most common adverse reactions in patients with thalassemia (incidence ≥6%) are nausea, vomiting, abdominal pain, arthralgia, ALT increased and neutropenia. The most common adverse reactions in patients with sickle cell disease or other anemias (incidence ≥6%) are pyrexia, abdominal pain, bone pain, headache, vomiting, pain in extremity, sickle cell anemia with crisis, back pain, ALT increased, AST increased, arthralgia, oropharyngeal pain, nasopharyngitis, neutrophil count decreased, cough and nausea.

Inform patients that their urine might show a reddish/brown discoloration due to the excretion of the iron-deferiprone complex. This is a very common sign of the desired effect, and it is not harmful.

Advise patients to avoid alcohol while taking Ferriprox tablets (twice-a-day). Consumption of alcohol while taking Ferriprox tablets (twice-a-day) may result in more rapid release of deferiprone.

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

References: 1. Hider RC, Hoffbrand AV. The role of deferiprone in iron chelation. N Engl J Med 2018;379:2140-50. 2. Coates TD. Physiology and pathophysiology of iron in hemoglobin-associated diseases. Free Radic Biol Med 2014;72:23-40. 3. Beris P. Transfusion and iron overload: Where are the risks? Haema 2019;10(1):29-38. 4. Coates TD, Wood JC. How we manage iron overload in sickle cell people. Br. J Haematol 2017;177(5):703-16. 5. Borgna-Pignatti C, et al. Survival and complications in patients with thalassemia major treated with transfusion and deferoxamine. Haematologica 2004;89:1187-1193. 6. 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. 7. Standards of care guidelines for thalassemia. Children’s Hospital & Research Center Oakland. 2012. Available online at: https://thalassemia.com/documents/SOCGuidelines2012.pdf. 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. 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. 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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