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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 than in older patients. These reactions are dose-dependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is continued1
  • 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

In a pivotal registration trial

<3% discontinuation rate due to treatment-related adverse events5

SAFETY PROFILE
ACROSS ANEMIAS




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TAILOR EXJADE DOSING
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TREATMENT GOALS


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References

  1. EXJADE® summary of product characteristics. West Sussex, United Kingdom: Novartis Europharm Limited; 2011.
  2. Piga A, Vichinsky E, Forni GL, Kilinc Y, Maseruka H, Kattamis A. Long-term efficacy and safety with deferasirox (EXJADE, ICL670), a once-daily oral iron chelator, in pediatric patients. Blood. 2007;110(11): Abstract #2774.
  3. Desferal® prescribing information. Steine, Switzerland: Novartis Pharma Stein AG; 2007.
  4. Cappellini MD, Elalfy MS, Kattamis A, Seymour JF, Lee CL, Porter JB. Efficacy and safety of once-daily, oral iron chelator deferasirox (EXJADE®) in a large group of regularly transfused patients with β-thalassemia major. Blood (American Society of Hematology Meeting Abstracts) 2008;112: Abstract 3878.
  5. Data on file. Novartis Pharma AG, Basel, Switzerland.
TRANSFUSION-DEPENDENT
β-THALASSEMIA		 MYELODYSPLASTIC SYNDROMES SICKLE CELL DISEASE APLASTIC AND OTHER ANEMIAS TOOLS AND RESOURCES ALL ABOUT EXJADE

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 β-thalassemia major aged 6 years and older.

EXJADE is also indicated for the treatment of chronic iron overload due to blood transfusion in patients aged 2 years and older with β-thalassemia major or other anemias when deferoxamine is contraindicated or inadequate.
Disclaimer: This is an international website for Exjade, and is intended for healthcare professionals outside the US. If you are a US resident, please click on the US Residents link at the top of this page. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.
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