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EU SmPC
Sickle Cell Safety Profile

Established Safety Profile in Children and Adults With Sickle Cell Disease Demonstrated
Over 5 Years1

Patients titrated ≥30 MG/KG/DAY Demonstrated A Continued Reduction in Body Iron Burden Without an Increase in Adverse Events or Evidence of Renal Dysfunction2
No Negative Impact on Growth or Sexual Maturity in Pediatric Patients2
No Progressive Increase in Mean Serum Creatinine Over 5 Years of Study2,3

Low discontinuation rates due to treatment-related
adverse events2:


EXJADE Low Discontinuation Rates

Safety details from the extension study

  • EXJADE had a favorable safety profile and appeared to be well tolerated
  • The adverse event profile was similar to the core study and other previous registration trials
  • Many of the adverse events reflected the underlying health condition (e.g., sickle cell anemia with crisis, or pyrexia, or infections) and were not treatment related
  • Among the most frequent drug-related adverse events were those known to be inherent to iron chelators, including:
    • Nausea
    • Diarrhea
    • Vomiting
    • Abdominal pain

SAFETY PROFILE
ACROSS ANEMIAS


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EXJADE DOSING OPTIONS

Titrate from the recommended starting dose of 20 mg/kg/day based on individual patient’s response and therapeutic goals. Please check the Prescribing Information for your region for details.

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References

  1. Cappellini MD, Porter J, El-Beshlawy A, et al; EPIC study investigators. Tailoring iron chelation by iron intake and serum ferritin: the prospective EPIC study of deferasirox in 1744 patients with transfusion-dependent anemias. Haematologica. 2010;95(4):557-566.
  2. Data on file. Novartis Pharma AG, Basel, Switzerland.
  3. Vichinsky E, Coates T, Thompson AA, et al. Deferasirox (Exjade®), the once-daily oral iron chelator, demonstrates safety and efficacy in patients with sickle cell disease (SCD): 3.5-year follow-up [American Society of Hematology 50th Annual Meeting abstract 1420]. Blood. 2008;112(11):Abstract 1420.
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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