Prescribing information

 

Image of patient with the words 'EXJADE: providing patients with convenient iron chelation1'Raise the bar in iron chelation therapy (ICT).

What is EXJADE?

EXJADE is a once-daily oral iron chelator available as a FCT formulation:1

  • Guidelines support the use of ICTs, such as EXJADE, for the management of iron overload in patients with MDS, SCD and thalassaemia2–7
  • The majority of AEs during chronic treatment with EXJADE are dose dependent, mostly mild-to-moderate, and generally transient1
  • EXJADE film-coated tablets (FCT) offers the convenience of simple dosing and administration compared to previous EXJADE dispersible tablet (DT) formulations1,8

Indication1

EXJADE is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.

EXJADE is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:

  • In paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years;
  • In adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older;
  • In adult and paediatric patients with other anaemias aged 2 years and older.

EXJADE is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.

 

Abbreviations: AEs, adverse events; DT, dispersible tablets; EMSO, European Society for Medical Oncology; FCT, film-coated tablets; ICT, iron chelation therapy; MDS, myelodysplastic syndromes; NCCN, National Comprehensive Cancer Network; pRBC, packed red blood cells; SCD, sickle cell disease; SMC, Scottish Medicines Consortium.

References

  1. EXJADE® film-coated tablets summary of product characteristics.
  2. Sickle Cell Society. Standards for clinical care of adults with sickle cell disease in the UK, 2nd Edition, 2018.
  3. Killick S, et al. Guidelines for the diagnosis and management of adult myelodysplastic syndromes. Br J Haematol 2014;164:503–525.
  4. NCCN. Myelodysplastic syndromes. Version 2. 2018.
  5. Fenaux, et al. Myelodysplastic syndromes: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2014;25 (Supplement 3):iii57–iii69.
  6. SMC. Re-submission: deferasirox 125mg, 250mg, 500mg dispersible tablets (EXJADE). SMC No. (347/07). 2016.
  7. United Kingdom Thalassaemia Society. Standards for the clinical care of children and adults with thalassaemia in the UK, 3rd Edition, 2016.
  8. 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-C005 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 pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]