Ferriprox® (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
- 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.
Ferriprox 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 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 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.
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.
- Ferriprox® (deferiprone) Prescribing Information. Chiesi, May 2020.
- Data on file.
- ApoPharma. Core Study Report for Study LA36-0310: Analysis of data from clinical studies of Ferriprox to evaluate its efficacy in patients with iron overload for whom previous chelation therapy has been inadequate. 2011.
- 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.
- Tricta F, et al. Deferiprone-induced agranulocytosis: 20 years of clinical observations. Am J Hematol 2016;91(10):1026-1031.
- 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 V4.0 February 2021