Long Term Safety Profile of EXJADE® For Treatment of Iron Chelation

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. EXJADE® HAS THE SAFETY DATA YOU NEED TO PRESCRIBE FOR THE LONG TERM EXJADE has a manageable safety profile in patients as young as 2 years old, with adverse events mostly mild to moderate and transient1
The safety and tolerability of EXJADE have been extensively studied in iron-overloaded patients across ages and with a wide range of chronic anemias, including1

beta-thalassemia

Myelodysplastic syndromes

Sickle cell disease

Other anemias

Four ongoing extension trials with patients followed for a median of 3.5 years (including some with >4 years of exposure to EXJADE) have confirmed the findings in the registration trials. Namely, EXJADE offers a manageable safety profile in adult and pediatric patients 2 years and older. In this long-term follow-up, the most common drug-related side effects—gastrointestinal events and rash—were generally mild to moderate and rarely severe. 2,3
Most Common(>4% Overall) Drug Related Adverse Events During Exteneded EXJADE Treatment (Median 3.4 Years)

Most Common(>4% Overall) Drug Related Adverse Events During Exteneded EXJADE Treatment (Median 3.4 Years)

aIn patients who develop diarrhea or vomiting, care should be taken to maintain adequate hydration.1

Increases in serum creatinine were mild, nonprogressive, and occurred in about 36% of patients in the core EXJADE trials1

Patients who experienced an elevation in serum creatinine in the registration trials showed no evidence of progression in the extension trials2

Elevations of liver transaminases were reported in about 2% of patients and were not dose dependent1

EXJADE has not been associated with growth retardation in children1

View long-term efficacy with EXJADE .EXJADE offers a consistent safety and tolerability profile across age groups, including pediatric and geriatric patients
In 1-year registration studies supporting the approval of EXJADE across age groups, 44.8% of patients receiving EXJADE were 15 years and younger, 8% were 5 years and younger, and 4.6% were 65 years and older. The adverse event profile in these patients did not different substantially from that in the general EXJADE patient population. EXJADE has not been associated with growth retardation in children. However, as a general precautionary measure, body weight and longitudinal growth in pediatric patients can be monitored at regular
intervals (every 12 months).1There have been postmarketing reports of renal failure, cytopenias, hepatic failure, and hypersensitivity in patients treated with EXJADE.
View important safety information .View summaries of EXJADE clinical trials .References: 1. EXJADE Swiss prescribing information. Berne, Switzerland: Novartis Pharma Schweiz Inc; 2008. 2. Cappellini MD, Vichinsky E, Galanello R, Piga A, Williamson P, Porter JB. Long-term treatment with deferasirox (EXJADE® , ICL670), a once-daily oral iron chelator, is effective in patients with transfusion-dependent anemias [poster 967]. Poster presented at: American Society of Hematology 49th Annual Meeting; December 8-11, 2007; Atlanta, GA. 3. Piga A, Vichinsky E, Forni GL, Kilinc Y, Maseruka H, Kattamis A. Long-term efficacy and safety with deferasirox (Exjade®, ICL670), a once-daily oral iron chelator, in pediatric patients [American Society of Hematology 49th Annual Meeting abstract 2774]. Blood. 2007;110(11):815a.