Aim: Transfusional iron overload in thalassaemia patients is a major cause of morbidity and mortality. This study was designed to evaluate the efficacy and safety of the oral iron chelator, deferasirox (DFX), in __ampersandsignbeta;-thalassaemia major (TM) patients. Methodology: The study was conducted in 2012- 2013, it consisted of a one year retrospective period, followed by a 12 month extension phase, included TM patients were classified into 3 groups, based on the selected DFX regimen. The efficacy endpoint of deferasirox was the evolution of serum ferritin levels from baseline values. DFX safety was evaluated according to the known adverse effects (AEs) . Results: Fifty nine patients were enrolled. DFX at doses 20 and 30 mg/kg p d showed non-significant changes of serum ferritin levels, while a significant effect after escalating the dose to 40 mg/ kg (p value 0.027, 0.014, 0.006, respectively). Regarding the safety, most of the AEs observed in the study were consistent with previous observations, apart from hypoglycemia. Conclusion: While adopting a close monitoring of possible side effects, iron overloaded TM patients may require 40 mg/kg p d, whenever initial lower doses have not been sufficiently efficient.