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Deferasirox

Renal Failure, Hepatic Failure and Gastrointestinal Hemorrhage

Renal Failure

  • Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.

  • Evaluate baseline renal function prior to starting or increasing Deferasirox dosing in all patients. Deferasirox is contraindicated in adult and pediatric patients with eGFR less than 40 mL/min/1.73 m2. Measure serum creatinine in duplicate prior to initiation of therapy. Monitor renal function at least monthly. For patients with baseline renal impairment or increased risk of acute renal failure, monitor renal function weekly for the first month, then at least monthly. Reduce the starting dose in patients with pre-existing renal disease. During therapy, increase the frequency of monitoring and modify the dose for patients with an increased risk of renal impairment, including use of concomitant nephrotoxic drugs, and pediatric patients with volume depletion or overchelation.

Hepatic Failure

  • Deferasirox can cause hepatic injury including hepatic failure and death.
  • Obtain serum transminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter.
  • Avoid the use of Deferasirox in patients with severe (Child Pugh-C) hepatic impairment and reduce the dose in patients with moderate (Child Pugh B) hepatic impairment.  

Gastrointestinal Hemorrhage

  • Deferasirox can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.
  • Monitor patients and discontinue desferasirox for suspected GI ulceration or hemorrhage.

Contraception

  • Counsel patients to use non-hormonal method(s) of contraception since deferasirox can render hormonalcontraceptives ineffective. 


FDA and Industry Communications

Patient Counseling Information

Medication Guides

Patient Medication Guide - EXJADE

Patient Medication Guide - JADENU/JADENU SPRINKLE

Package Inserts

Exjade

Updated August 2019