This informational website is developed by Chiesi USA, and is intended only for HCPs that are residents of the United States.

The Ferriprox safety profile has been established in 70+ thalassemia studies worldwide1

Ferriprox has 20 years of worldwide post-marketing experience in thalassemia: (9 in the US) and over 98,000 patient-years of use.1

Agranulocytosis and Neutropenia

In clinical trials of 196 Ferriprox-treated patients with sickle cell disease or other anemias:2

  • agranulocytosis occurred in 1.5% of patients

Fatal agranulocytosis can occur with Ferriprox use. Ferriprox can also cause neutropenia, which may foreshadow agranulocytosis.

Sickle cell disease

Most common adverse reactions occurring in ≥%6 of patients with sickle cell disease and other anemias treated with Ferriprox in clinical trials

Adverse reaction% Patients (n=152)
Pyrexia28
Abdominal pain26
Bone pain25
Headache20
Vomiting19
Pain in extremity18
Sickle cell anemia with crisis17
Back pain13
Alanine aminotransferase increased12
Aspartate aminotransferase increased11
Arthralgia10
Oropharyngeal pain10
Nasopharyngitis9
Neutrophil count decreased8
Cough8
Nausea7

Adverse reaction frequencies are based on adverse events reported regardless of relationship to study drug.

Grouped term

To minimize gastrointestinal upset when first starting therapy, dosing can start at 45 mg/kg/day and increase by 15 mg/kg/day until the full prescribed dose is achieved.2

Monitoring your patients on Ferriprox is straightforward:2
Absolute neutrophil count (ANC)
drop drop drop

Once, at baseline; and then weekly, on therapy

Establishes patient’s baseline level and addresses the risk of neutropenia, agranulocytosis, and infection.

Serum liver enzymes
liver liver liver

Monthly, on therapy

Increased ALT levels were observed in clinical trials. Consider interruption of therapy if there is a persistent increase in serum transaminase levels.

Plasma zinc concentration

Frequency: If necessary

  • Decreased plasma zinc concentrations have been observed in patients on Ferriprox

PATIENT COUNSELING INFORMATION

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. Data on file. 2. Ferriprox® (deferiprone) Prescribing Information. Chiesi, April 2021.

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