1. Medicines
  2. Haematology
  3. EXJADE®▼ (deferasirox)
  4. Safety profile

Prescribing information

 

Safety profile

    

Well-established safety profile1–3

The majority of AEs related to EXJADE are mild and manageable1–3

  • The most common AEs reported during chronic treatment with EXJADE in adult and paediatric patients include GI disturbances (mainly nausea, vomiting, diarrhoea or abdominal pain) and skin rash1,2
  • Other side effects affecting renal function (such as proteinuria and increased serum creatinine) and hepatic function (such as increases in serum transaminases, bilirubin and alkaline phosphatase) may be observed and require appropriate safety monitoring1,2
  • Caution should be used when treating elderly patients with EXJADE, due to a higher frequency of AEs (in particular, diarrhoea)1,2

Tolerability during the ECLIPSE study3

  • EXJADE was generally well-tolerated and laboratory parameters remained stable throughout
  • Diarrhoea, nausea and abdominal pain were the most common AEs and severe AEs reported for patients administered either EXJADE DT and EXJADE FCT

Most common adverse events overall >10% in any group3*

Graph showing the most common adverse events occurring in >10% of patients receiving EXJADE DT or EXJADE FCT

Most common severe AEs regardless of causality3

Graph showing the most common adverse events occurring in >10% of patients receiving EXJADE DT or EXJADE FCT

Tolerability during the TELESTO study4

  • Rate of severe AEs per 100-patient years was comparable with placebo when adjusted for different exposure time, with the exception of increased serum creatine concentration in the EXJADE group (15.9 vs. 0.9)
  • Lower levels of hospitalisation due to congestive heart failure (0.7 vs. 3.9%) and liver function impairment (0.7 vs. 1.3%) were observed with EXJADE
  • Non-fatal events were more common in the placebo group (15.8%) than with EXJADE (9.4%)

Exposure-adjusted AEs (>10% in either arm)4

Table showing exposure-adjusted adverse events occurring in >10% of patients receiving deferasirox or placebo

Recommended safety monitoring2

Table showing recommended tests and frequency during EXJADE treatment

*Groups defined as EXJADE DT, n=86 EXJADE FCT, n=87. †Dose adjustments may be made in steps of 3.5 to 7 mg/kg/day and should be tailored to the individual patient’s response and therapeutic goals.2

 

Abbreviations: AE, adverse event; DT, dispersible tablets; FCT, film-coated tablets; GI, gastrointestinal; ICT, iron chelation therapy; IR, incidence rate; MDS, myelodysplastic syndromes; RTI, respiratory tract infection; SAE, severe adverse event; STY, subject treatment years; UPCR, urine protein to creatinine ratio.

References

  1. EXJADE® dispersible tablets summary of product characteristics.
  2. EXJADE® film-coated tablets summary of product characteristics.
  3. 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.
  4. Angelucci E, et al. Iron chelation in transfusion-dependent patients with Low- to Intermediate-1-risk myelodysplastic syndromes: a randomized trial. Ann Intern Med. 2020 Mar. [Epub ahead of print].
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UK | March 2021 | 111826
Haematology
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at 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]