Prescribing information

 

   

Objective1

A prospective 4-year, multinational, extension study evaluating the long-term safety and efficacy of EXJADE in transfusion-dependent, iron-overloaded patients with SCD.

Trial cohort1

Overall, 185 patients received one dose of EXJADE in the extension study of which 90 patients (48.6%) were aged <16 years.

Key inclusion criteria1

  • Patients with SCD who had completed the 1-year, Phase II, randomised deferoxamine-controlled study
  • Ferritin levels ≥500 μg/L

EXJADE treatment regimen1

  • In the EXJADE cohort, the initial dosage was either maintained or increased by 5 or 10 mg/kg/day depending on patients’ serum ferritin trends in the 1-year core study
  • In the deferoxamine crossover cohort, the recommended initial EXJADE dose was 20 mg/kg/day in patients receiving 2–4 units of pRBC per month*
  • Dose adjustments in increments of 5 or 10 mg/kg per day were allowed every 3 months based on trends in serum ferritin levels and safety parameters

Assessments1

  • The safety and tolerability profile of treated patients from BL to Year 5
  • To evaluate the efficacy of EXJADE in reducing iron burden based on change in serum ferritin levels from BL to Year 5

*A 20 mg/kg/day EXJADE DT dose is equivalent to 14 mg/kg/day EXJADE FCT; a 30 mg/kg/day EXJADE DT dose is equivalent to 21 mg/kg/day EXJADE FCT.2,3

Initial EXJADE doses of 10 or 30 mg/kg/day could be considered for patients with lower or higher transfusion requirements, respectively.

 

Abbreviations: BL, baseline; DT, dispersible tablets; FCT, film-coated tablets; ICT, iron chelation therapy; pRBC, packed red blood cells; SCD, sickle cell disease.

References

  1. Vichinsky E, et al. Long-term safety and efficacy of deferasirox (EXJADE®) for up to 5 years in transfusional iron-overloaded patients with sickle cell disease. Br J Haematol 2011;154(3):387–97.
  2. EXJADE® dispersible tablets summary of product characteristics.
  3. EXJADE® film-coated tablets summary of product characteristics.
HCP20-C005g June 2020.
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