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Healthcare Professionals Patients & Caregivers

Indication

Deferiprone is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

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.

Limitations of Use
Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with other chronic anemias.

Important Safety Information

WARNING: AGRANULOCYTOSIS AND NEUTROPENIA

  • Deferiprone 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 deferiprone and monitor weekly while on therapy.
  • Interrupt deferiprone if infection develops and monitor the ANC more frequently.
  • Advise patients taking Deferiprone to report immediately any symptoms indicative of infection.

Deferiprone is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation.

In clinical studies, 7.5% of 642 patients treated with deferiprone developed increased ALT values. Four (0.62%) deferiprone-treated subjects discontinued the drug due to increased serum ALT levels and 1 (0.16%) due to an increase in both ALT and AST. Monitor serum ALT values monthly during therapy with deferiprone 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.

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

Avoid co-administration of deferiprone 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 deferiprone and drugs or supplements containing polyvalent cations (e.g., iron, aluminum, or zinc).

The most common adverse reactions are (incidence ≥5%) nausea, vomiting and abdominal pain, alanine aminotransferase increased, arthralgia, and neutropenia.

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

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

Indication

Deferiprone is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Important Safety Information

WARNING: AGRANULOCYTOSIS AND NEUTROPENIA

  • Deferiprone can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis.

Indication

Deferiprone is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

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.

Limitations of Use
Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with other chronic anemias.

Important Safety Information

WARNING: AGRANULOCYTOSIS AND NEUTROPENIA

  • Deferiprone 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 deferiprone and monitor weekly while on therapy.
  • Interrupt deferiprone if infection develops and monitor the ANC more frequently.
  • Advise patients taking Deferiprone to report immediately any symptoms indicative of infection.

Deferiprone is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation.

In clinical studies, 7.5% of 642 patients treated with deferiprone developed increased ALT values. Four (0.62%) deferiprone-treated subjects discontinued the drug due to increased serum ALT levels and 1 (0.16%) due to an increase in both ALT and AST. Monitor serum ALT values monthly during therapy with deferiprone 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.

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

Avoid co-administration of deferiprone 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 deferiprone and drugs or supplements containing polyvalent cations (e.g., iron, aluminum, or zinc).

The most common adverse reactions are (incidence ≥5%) nausea, vomiting and abdominal pain, alanine aminotransferase increased, arthralgia, and neutropenia.

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

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