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Objective  Patients with non‐transfusion‐dependent thalassemia ( NTDT ) often develop iron overload and related complications, and may require iron chelation. However, the risk of over‐chelation emerges as patients reach low, near‐normal body iron levels and dose adjustments may be needed. In the  THALASSA  study, the threshold for chelation interruption was  LIC  <3 mg  F e/g dw ( LIC <3); 24 patients receiving deferasirox for up to 2 yr reached this target. A  post hoc  analysis was performed to characterize the safety profile of deferasirox as these patients approached  LIC <3.    Methods   THALASSA  was a randomized, double‐blind, placebo‐controlled study of two deferasirox regimens (5 and 10 mg/kg/d) versus placebo in patients with  NTDT . Patients randomized to deferasirox or placebo in the core could enter a 1‐yr extension, with all patients receiving deferasirox (extension starting doses based on  LIC  at end‐of‐core and prior chelation response). The deferasirox safety profile was assessed between baseline and 6 months before reaching  LIC <3 (Period 1), and the 6 months immediately before achieving  LIC <3 (Period 2).    Results  Mean ±  SD  deferasirox treatment duration up to reaching  LIC <3 was 476 ± 207 d, and deferasirox dose was 9.7 ± 3.0 mg/kg/d. The exposure‐adjusted  AE  incidence regardless of causality was similar in periods 1 (1.026) and 2 (1.012). There were no clinically relevant differences in renal and hepatic laboratory parameters measured close to the time of  LIC <3 compared with measurements near the previous  LIC  assessment.    Conclusions  The deferasirox safety profile remained consistent as patients approached the chelation interruption target, indicating that, with appropriate monitoring and dose adjustments in relation to iron load, low iron burdens may be reached with deferasirox with minimal risk of over‐chelation.

Approaching low liver iron burden in chelated patients with non‐transfusion‐dependent thalassemia: the safety profile of deferasirox