EXJADE® (Deferasirox) | Efficacy of EXJADE® in Myelodysplastic Syndrome (MDS) Patients

MENUEfficacy - IntroductionEfficacy - Chelation at Essential SitesEfficacy - Dose-Dependent ChelationEfficacy - Long-Term EfficacyEfficacy - 24-Hour Activity Efficacy - Clinical Trial SummariesSafety - Long-Term Safety ProfileSafety - Side Effect ManagementSafety - Monitoring GuidelinesSafety - Important Safety InformationDosing - Dosing GuidelinesDosing - Dose CalculatorDosing - Serum Ferritin TrackerPatient Types - IntroductionPatient Types - beta-ThalassemiaPatient Types - Myelodysplastic SyndromesPatient Types - Sickle Cell DiseasePatient Types - Other AnemiasPatient Types - IPSS CalculatorCompliance Support - IntroductionCompliance Support - Side Effect ManagementCompliance Support - Educational ToolsExjade Resources - Summary of Resources and ToolsExjade Resources - Related LinksExjade Resources - Mechanism of ActionAbout Iron Toxicity - Iron ToxicityAbout Iron Toxicity - Morbidity and MortalityAbout Iron Toxicity - Screening and MonitoringAbout Iron Toxicity - Managing Iron ToxicityExjade FAQsAbout Novartis OncologyContact UsSite MapTerms of UsePrivacy PolicyCountry Sites - CanadaCountry Sites - GermanyCountry Sites - JapanCountry Sites - NetherlandsCountry Sites - SwitzerlandCountry Sites - United StatesSwiss PIEU SmPCNovartis OncologyPubmedAre You An Exjade Prescriber Seeking Tips For Treatment Success?Are You Considering Exjade And Seeking Compelling Data?Are You A Researcher Seeking Exjade Information Resources?Swiss PIEU SmPCExjade Important Safety Information EXJADE is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in adult and pediatric patients (aged 2 years and over). Please click here for Swiss Prescribing Information. Please click here for EU SmPC. Please click here for Exjade Important Safety Information.References: 1. Cappellini MD, Cohen A, Piga A, et al. A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia. Blood. 2006;107(9):3455-3462. 2. Eleftheriou P, Tanner M, Pennel D, Porter JB. Response of myocardial T2* to oral deferasirox monotherapy for 1 year in 29 patients with transfusion-dependent anaemias; a subgroup analysis [11th Congress of the European Hematology Association abstract 0999]. Haematologica. 2006;91(s1):366. 3. Wood J, Thompson AA, Paley C, et al. Exjade® reduces cardiac iron burden in chronically transfused beta-thalassemia patients: an MRI T2* study [American Society of Hematology 49th Annual Meeting abstract 2781]. Blood. 2007;110(11):817a. 4. EXJADE Swiss prescribing information. Berne, Switzerland: Novartis Pharma Schweiz Inc; 2008. Disclaimer: This is an international website for EXJADE, and is intended for healthcare professionals outside the U.S. If you are a U.S. resident, please click on the U.S. residents link at the top of this page. The information on this site is not country-specific, and may contain information that is outside the approved indications in the country in which you are located.© 2008 Novartis AG. Use of this website is subject to our Terms of Use. Iron toxicity is a survival risk in myelodysplastic syndromes—making chelation a priority
A recent retrospective analysis of 467 patients with myelodysplastic syndromes (MDS) published in the Journal of Clinical Oncology demonstrated significantly different prognoses and survival times among World Health Organization (WHO) subgroups. Mean survival was 9 years for patients with refractory anemia (RA) versus about 4 years in patients with refractory cytopenia with multilineage dysplasia.1
The longer survival of patients with RA makes them more prone to the long-term toxicity associated with iron toxicity. A survival analysis of patients with MDS found a 30% higher risk of death for every 500 ng/mL increase in serum ferritin above the threshold of 1000 ng/mL.1
According to a recent prospective analysis of 165 patients with MDS at 18 centers, chelation therapy more than doubled overall survival in patients with an International Prognostic Scoring System (IPSS) score of 01 (low-risk to intermediate-1–risk MDS).2 Median Survival in Patients with Low-Risk to Intermediate-1-risk MDS, Chleated Versus Nonchelated

Median Survival in Patients with Low-Risk to Intermediate-1-risk MDS, Chleated Versus Nonchelated

View IPSS prognostic factors for life expectancy
Chelation guidelines in MDSLeading MDS groups recommend chelation therapyNational Comprehensive Cancer Network (NCCN): Myelodysplastic Syndromes (MDS) Foundation:

Transfusion-dependent patients

Patients with ferritin levels >1000 µg/L

Patients with low-risk MDS

Patients with life expectancy of at least 1 year

Patients without comorbidities that would limit prognosis

Candidates for allograft

Patients in whom there is a need to preserve organ function

NEW Canadian Consensus Guidelines and the NEW Spanish Guide:

Patients with lower-risk MDS

IPSS score 0 or 1 (low or intermediate-1 risk)
WHO classification of RA, RA with ringed sideroblasts, or 5q-syndrome

Candidates for allogeneic stem cell transplantation

Both the Canadian and Spanish guidelines recommend EXJADE as a chelation option for patients with MDS and iron toxicity.3,4

Guidelines for detecting iron toxicity

Serum ferritin5

Liver iron concentration (biopsy or MRI)5

Guidelines for initiating chelation therapy

When serum ferritin levels >1000 µg/L4

Continuation of treatment should be considered for as long as transfusion therapy continues and iron toxicity remains clinically relevant

MDS patient profilePatient profile: (MDS) George, age 72

Treatment history

Regular transfusions for intermediate-1–risk MDS

2 units of packed red blood cells per month for the past 2 years

Current challenges

High iron burden:

Serum ferritin: 3214 µg/L

EXJADE efficacy in MDS EXJADE can have a major impact on the markers of iron toxicity in myelodysplastic syndromes (MDS)

EXJADE 30 mg/kg/day substantially reduced mean serum ferritin by >1500 µg/L after 1 year.1

Substantial reductions in liver iron concentration (LIC)
LIC: -10.7 and -9.4 mg Fe/g of dry weight, respectively, with EXJADE 20 mg/kg/day and 30 mg/kg/day.1
View long-term efficacy with EXJADE View Important safety information Reference: 1. Porter J, Galanello R, Saglio G, et al. Relative response of patients with myelodysplastic syndromes and other transfusion-dependent anaemias to deferasirox (ICL670): a 1-yr prospective study. Eur J Haematol. 2008;80(2):168-176.