Prescribing information

 

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EXJADE offers simple and convenient dosing for your patients compared with previous formulations.1,2

Non-transfusion-dependent thalassaemia

EXJADE FCTs demonstrate higher bioavailability compared to the EXJADE DTs formulation. In case of switching from DTs to FCTs, the dose of the FCTs should be 30% lower than the dose of the DTs, rounded to the nearest whole tablet.

Starting dose1

  • Recommended initial daily dose: 7 mg/kg/day

Recommended doses for non-transfusion-dependent thalassaemia syndromes1

Table showing the recommended doses of EXJADE for non-transfusion-dependent thalassaemia syndromes

Dose adjustments1

  • It is recommended that serum ferritin is monitored every month
  • If necessary, the dose of EXJADE may be adjusted every 3–6 months based on trends in LIC or serum ferritin

Adjustments based on LIC or serum ferritin1

Table showing the recommended EXJADE dose adjustments based on LIC or serum ferritin

Dose adjustments1

  • In patients where LIC was not assessed and serum ferritin is ≤2,000 μg/L, dosing should not exceed 7 mg/kg
  • For patients in whom the dose was increased to >7 mg/kg, dose reduction to 7 mg/kg or less is recommended when LIC is <7 mg Fe/g or serum ferritin is ≤2,000 μg/L

 

*LIC is the preferred method for iron overload determination.

Abbreviations: DT, dispersible tablet; dw, dry weight; FCT, film-coated tablet; ICT, iron chelation therapy; LIC, liver iron concentration.

References

  1. EXJADE® film-coated tablets summary of product characteristics.
  2. Taher A, et al. New film-coated tablet formulation of deferasirox is well tolerated in patients with thalassemia or lower-risk MDS: Results of the randomized, Phase II ECLIPSE study. Am J Hematol 2017;92(5):420–428.
HCP20-C005k June 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the patient safety information (PSI) tool at https://psi.novartis.com
If you have a question about the product, please contact Medical Information on 01276 692255 or by email at [email protected]