Beta-Thalassemia Safety Profile

EXJADE Provides Chelation Therapy With an Established Safety Profile

Safety in pediatric and adult patients

  • The most frequent reactions reported during chronic treatment with EXJADE in adult and pediatric patients include gastrointestinal disturbances in about 26% of patients (mainly nausea, vomiting, diarrhea or abdominal pain) and skin rash in about 7% of patients. Diarrhea is reported more commonly in pediatric patients aged 2 to 5 years and in the elderly. These reactions are dose-dependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is continued1
  • During clinical trials, increases in serum creatinine of >33% on ≥2 consecutive occasions, sometimes above the upper limit of the normal range, occurred in about 36% of patients. These were dose-dependent. About two-thirds of the patients showing serum creatinine increase returned below the 33% level without dose adjustment. In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption. Cases of acute renal failure have been reported following post-marketing use of EXJADE. In some post-marketing cases, renal function deterioration has led to renal failure requiring temporary or permanent dialysis.
  • EXJADE treatment revealed no negative impact on physical or sexual development in pediatric patients2
    • In comparison, high dose Desferal® has been associated with growth retardation. Pediatric patients receiving Desferal® should be monitored every 3 months for negative effects to growth and body weight3
  • 90% of the pediatric patient population in a clinical trial (aged 2-16 years) remained on EXJADE over a median period of 3.5 years with manageable adverse events2
  • 95% of adverse reactions were mild to moderate and transient in severity among patients with β-thalassemia in the largest chelation trial to date4,5

In a pivotal registration trial

<3% discontinuation rate due to treatment-related adverse events6


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