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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

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Regular blood transfusions Regular blood transfusions Regular blood transfusions

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

NTBI is absorbed into each organ independently1

Transfusional iron overload significantly impacts morbidity and mortality in sickle cell disease4,5

As lifetime exposure to iron increases, iron-related complications may become more frequent.6

Graph representing Iron overload review Graph representing Iron overload review Graph representing Iron overload review

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%.4

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

A natural history study in 199 transfused sickle cell disease patients vs. 64 non-transfused patients also found iron overload resulted in:5‡

Hospital icon

Increased hospitalization

4.1 HOSPITALIZATIONS PER YEAR

VS.

2.1 HOSPITALIZATIONS PER YEAR FOR NON-TRANSFUSED PATIENTS (p<0.001)5

There was a positive relationship between severity of iron overload, assessed by serum ferritin, and the frequency of hospitalizations (r=0.20; p=0.009).5

Heartrate icon

Increased mortality

17 DEATHS WERE REPORTED IN 23.5 ± 10 MONTHS OF FOLLOW-UP.5

The mortality rate in transfused adult subjects with sickle cell disease is 3 times greater than the general US population.5

Iron chelation therapy resulted in better overall survival, but only if it was instituted early and compliance was maintained4

Based on a study of patients 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 patients with thalassemia and 199 patients with sickle cell disease who received regular transfusions were included in the study group and compared with 64 non-treated sickle cell disease patients as controls.

IRON MONITORING IN SICKLE CELL DISEASE

If removal of NTBI can be achieved, complications of iron overload may be reduced or eliminated6

Objectives of iron chelation therapy2,7

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

Objectives of iron chelation therapy Objectives of iron chelation therapy Objectives of iron chelation therapy

Iron chelation needs to be adjusted regularly or even switched depending on iron level, weight, and tolerance to side effects.1,6

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

Sickle Cell Disease treatment guidelines support regular monitoring of serum ferritin, and cardiac and liver MRI T2*.7

Recommended target levels Recommended target levels Recommended target levels

§MRI=magnetic resonance 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: What are the risks? Haema 2019;10(1):29-38.4.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;93:943-52.5.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;82:255-65.6.Coates TD, Wood JC. How we manage iron overload in sickle cell people. Br. J Haematol 2017;177(5):703-16.7.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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