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Dear Healthcare Professional:

New Ferriprox® 1000 mg tablets reduce pill burden compared to 500 mg tablets.

ApoPharma USA™ Inc. is pleased to announce the introduction of a NEW Ferriprox 1000 mg tablet. The new Ferriprox 1000 mg formulation reduces pill burden compared to 500 mg.

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.1

New Ferriprox 1000 mg tablets provide the same proven efficacy of cardiac iron reduction, liver iron reduction and serum ferritin reduction, with half the number of pills per dose. The new Ferriprox 1000 mg tablet is similar in size to the 500 mg tablet.1,2

In addition to proven efficacy in iron reduction, Ferriprox 1000 mg tablets have the same safety profile as Ferriprox 500 mg tablets, and no dosage adjustment is required in patients with mild to severe renal impairment or mild to moderate hepatic* impairment.1

We are proud to offer this dosing option and reduce the patient’s pill burden, which reflects our long-standing commitment to thalassemia patients suffering from iron overload.
Ferriprox successfully reduced cardiac iron after 1 year of therapy
Mike Woolcock
SVP, Commercial Operations
ApoPharma USA Inc.
Indication

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.

Limitation 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/NEUTROPENIA
  • Ferriprox can cause agranulocytosis that can lead to serious infections and   death. Neutropenia may precede the development of agranulocytosis. [see Warnings and Precautions (5.1)]
  • Measure the absolute neutrophil count (ANC) before starting Ferriprox therapy and monitor the ANC weekly on therapy.
  • Interrupt Ferriprox if infection develops and monitor the ANC more frequently. [see Warnings and Precautions (5.1)]
  • Advise patients taking Ferriprox to report immediately any symptoms indicative of infection. [see Warnings and Precautions (5.1)]

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

Ferriprox can cause fetal harm. Women should be advised of the potential hazard to the fetus and to avoid pregnancy while on this drug.

In clinical studies, 7.5% of 642 subjects 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. 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 Ferriprox therapy. Monitor plasma zinc, and supplement in the event of a deficiency.

Avoid concomitant use with other drugs known to be associated with neutropenia or agranulocytosis; however, if this is not possible, closely monitor the absolute neutrophil count. Allow at least a 4-hour interval between Ferriprox and mineral supplements and antacids that contain polyvalent cations (e.g., iron, aluminum, and zinc).

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

For Full Prescribing Information, including BOXED WARNING and Medication Guide, please click here.
* Ferriprox was not studied in a severely hepatically impaired patient population.
1. Ferriprox (deferiprone) Prescribing Information. ApoPharma USA, 2019.
2. ApoPharma. Oncology Drug Advisory Committee Briefing Document NDA #21-825. Ferriprox (deferiprone) is an iron chelator for the treatment of patients with transfusional iron overload when current chelation therapy is inadequate. 2011.

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ApoPharma USA, Inc. 2400 N. Commerce Parkway, Suite 300, Weston FL 33326, USA.

ApoPharma USA, Inc.™ is a trademark of Apotex Technologies Inc.
Ferriprox® is a registered trademark of Apotex Technologies Inc.
© ApoPharma Inc. All rights reserved.
FERR-0532-2019-US August 2019