Deferasirox

Renal Failure

• Deferasirox tablets 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 tablets dosing in all patients. Deferasirox tablet is contraindicated in adult and pediatric patients with eGFR less than 40 mL/minute/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 preexisting 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 tablets can cause hepatic injury including hepatic failure and death.

• Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter.

• Avoid use of deferasirox tablets 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 tablets 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 deferasirox tablets for suspected GI ulceration or hemorrhage

 

 

Limitations of Use:

Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s JADENU^® (deferasirox) tablets. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.