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  • FULL INDICATION AND IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

Cardiac iron monitoring by MRI T2* is essential for people with transfusion-dependent thalassemia

Learn more about why and where to get it done.
  • Why track cardiac iron?

  • How should cardiac iron be evaluated?

  • What do cardiac MRI T2* values mean?

  • When should cardiac iron be measured?

  • Where can I get MRI T2* done?

Centers were identified based on their capacity to perform cardiac T2* monitoring.
For your convenience we have also specified the liver imaging services offered by these sites, but it should be noted that this map does not represent a complete listing of centers offering liver iron assessment.

    MRI T2* Facility Search page graphic: Question Mark icon

    In patients with transfusion-related iron overload, the two key target organs for iron accumulation are the heart and liver. Although the liver is the major site of iron storage, the smaller amount of iron that goes to the heart can have more serious clinical consequences, including arrhythmias, cardiac failure, and death.

    Since serum ferritin and liver iron are not strong predictors of the level of iron deposition in the heart, cardiac iron content should be directly evaluated on a regular basis in patients with transfusion-dependent thalassemia syndromes, in order to determine the risk of iron-related cardiac damage and monitor the effectiveness of the patient’s current chelation regimen in removing excess iron from the heart. [SOC guidelines 2012; Pennell 2013 AHA guidelines]

    MRI T2* Facility Search page graphic: Gear icon

    Magnetic resonance imaging (MRI) is currently the preferred method for assessing iron levels in the heart, as it is non-invasive, widely available, and able to measure iron load in a reliable and quantitative manner. The recommended MRI sequence for measuring cardiac iron is T2*, which is inversely correlated with iron content, i.e., the lower the value, the higher the iron level. [SOC guidelines 2012; Pennell 2013 AHA guidelines]

    MRI T2* Facility Search page graphic: search icon

    Cardiac T2* values 20 milliseconds (ms) or lower indicate clinically significant levels of cardiac iron loading. [SOC guidelines 2012; Pennell 2013 AHA guidelines]

    MRI T2* Facility Search page graphic: clock icon

    Assessment of cardiac iron by MRI T2* should start early in the patient’s life, ideally around age 6 to 10. If an older patient has never previously been evaluated using cardiac MRI, he or she should undergo a baseline scan as soon as possible to help determine his or her risk profile and define the optimal strategy for chelation therapy. [Pennell 2013 AHA guidelines]

    The recommended frequency of ongoing cardiac MRI monitoring will depend on the patient’s degree of cardiac iron overload: [Pennell 2013 AHA guidelines]

    • If a patient’s initial scan(s) show(s) heart iron in the normal range, (above 20 ms), follow-up scans should be performed approximately annually thereafter.
    • Scans should be completed more frequently – every 6 months – in patients at higher cardiac risk due to elevated cardiac iron content (T2* under 10 ms), poor treatment compliance, or reduced left ventricular ejection fraction.

    MRI T2* Facility Search page graphic: map location icon

    The cardiac T2* sequence can be run on most MRI machines currently in use, provided that the appropriate software has been installed. To find the center nearest you that offers cardiac T2*, enter your address and/or ZIP code into the interactive map.

     

    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 V3.0 November 2020

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