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What is Ferriprox® (deferiprone)?

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.

Learn more about Ferriprox >

How does Ferriprox remove cardiac iron?

Deferiprone is a chelating agent with an affinity for ferric ion (iron III). Deferiprone binds with ferric ions to form neutral 3:1 (deferiprone:iron) complexes.

Deferiprone has been observed to reduce excess intracellular iron, including myocytes, which may be related to its high ability to pass through cell membranes due to its low molecular weight, neutral charge, and balanced lipophilicity.

See how Ferriprox works to remove cardiac iron >

What do the guidelines recommend for the treatment of iron loading in the heart?

Treatment guidelines recommend preventing significant iron loading from the start, not just in an emergency. The American Heart Association (AHA) recommends yearly MRI T2* assessments of the heart. Ferriprox has been proven to reduce iron levels in the heart and liver and to decrease serum ferritin. To help your patients find a certified MRI T2* facility closest to them, use our facility search tool.

Try our Ferriprox MRI T2* facility locator >

Understanding that MRI T2* assessment is important to assess iron level in the heart and liver, how do I find the closest certified facility for my patient?

Cardiac and liver iron monitoring by MRI T2* is essential for patients with transfusion-dependent thalassemia. Use the MRI T2* facility search to find the one nearest you.

Try our MRI T2* facility >

Is Ferriprox suitable for patients with renal or hepatic impairment?

Yes. No adjustment of the Ferriprox dosage regimen is required in patients with impaired renal function (mild to severe) or impaired hepatic¶¶ function (mild to moderate).

¶¶ Ferriprox was not studied in a severely hepatically impaired patient population.

See more about Ferriprox dosing for optimal chelation >

What are the monitoring requirements for Ferriprox?

Monitoring patients on Ferriprox is straightforward. Absolute neutrophil count (ANC) is measured once before treatment initiation and then weekly while on therapy. Serum liver enzymes are evaluated monthly, on therapy, and plasma zinc concentration is monitored if necessary.

See more safety information >

What steps should I tell patients to take if they develop a fever or flu-like symptoms while taking Ferriprox?

If your patient develops a fever, sore throat or mouth sores, flu-like symptoms, or chills and severe shaking, they should follow these three steps:

FAQ: Three steps

Ferriprox patients receive a wallet card with these three steps printed on it with every medication shipment. To request wallet cards for your office, please contact the Chiesi Total CareSM team at 1-866-758-7071.

Visit the Chiesi Total Care website >

How high can I titrate the Ferriprox dose?

The FDA-approved dosing for Ferriprox is 75-99 mg/kg/day. Start your patient on 75 mg/kg/day, then titrate up to meet chelation targets. Increasing the dose of Ferriprox up to 99 mg/kg/day may improve efficacy in iron chelation. The incidence of neutropenia and agranulocytosis is not dose related within the therapeutic range.

See more about Ferriprox dosing >

Does the incidence of agranulocytosis increase with Ferriprox dose?

The incidence of neutropenia and agranulocytosis is not dose-related within the therapeutic range. The FDA-approved dosage of Ferriprox is 75-99 mg/kg/day.

See more about Ferriprox dosing >

What formulations of Ferriprox are available?

Ferriprox offers a choice of formulations in oral tablets and oral solution formats. Ferriprox offers twice-daily dosing with blister packaging designed for life on the go. Talk to your patients about switching to Ferriprox Twice-A-Day.

Learn more about Ferriprox dosage forms >

Why switch to Ferriprox Twice-A-Day tablets?

Ferriprox offers twice-daily dosing with blister packaging designed for lif on the go.

Ferriprox Twice-A-Day tablets provide proven iron reduction and an established safety profile similar to the IR (immediate-release) tablets.

Serum ferritin‡ reduction

  • In the clinical trial, 50% of patients experienced at least a 20% reduction in serum ferritin within 1 year of therapy.1,6

Cardiac iron reduction

  • In the clinical trial, there was an increase in cardiac MRI T2* from a mean at baseline of 11.8±4.9 ms to a mean of 15.1±7.0 ms after approximately 1 year of treatment.1,6†

Liver iron reduction

  • In the clinical trial, 42% of patients experienced at least a 20% reduction in liver iron within 1 year of therapy ( 95% CI, 32%-51%).2†
ms=milliseconds
† The clinical significance of this observation is not known.
‡ Serum ferritin indicates total body iron level.

 

Ferriprox tablets are also scored and may be broken in half for easy swallowing or dosage adjustments. Each half is 500 mg. Flexible titration across the dose range helps patients reach their chelation targets.

Talk to your patients about switching to Ferriprox Twice-A-Day.

See the difference in pills per day >

How do I switch my patients to Ferriprox Twice-A-Day from Three-Times-A-Day tablets?

Ferriprox offers twice-daily dosing.

FAQ: Dosing Chart
The FDA-approved dosage of Ferriprox is 37.5 mg/kg to 49.5 mg/kg actual body weight, orally, twice daily with food for a total daily dose of 75 mg/kg to 99 mg/kg.

In order to transition your patients to new Ferriprox Twice-A-Day tablets, a new Rx form must be completed.

Download the form here > or call Chiesi Total CareSM at 1-866-565-7794

What is the patient support program called and what can my patients expect from the program?

The patient support program is called Chiesi Total CareSM. Chiesi Total Care is a comprehensive support program that provides exceptional service to healthcare professionals and their patients. A single call to your dedicated Chiesi Total Care team is all it takes to guide you through the process of getting the patient started on Ferriprox therapy.

Get your patient started >

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.

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.

 

References:

  1. Ferriprox® (deferiprone) Prescribing Information. Chiesi, May 2020.
  2. Data on file.
  3. 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.
  4. 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.
  5. Tricta F, et al. Deferiprone-induced agranulocytosis: 20 years of clinical observations. Am J Hematol 2016;91(10):1026-1031.
  6. 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

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