Deferasirox (Jadenu; Jadenu Sprinkle)
For more on this Drug Safety Labeling Change, click here and here.
For full prescribing information, click here.
Updated Boxed Warning
WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE
Renal Failure
JADENU or JADENU SPRINKLE can cause acute renal failure and death...
Evaluate baseline renal function prior to starting or increasing Jadenu or Jadenu Sprinkle dosing in all patients. JADENU or JADENU SPRINKLE 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 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 [see Dosage and Administration (2.1, 2.4, 2.5), Warnings and Precautions (5.1) Adverse Reactions (6.1,6.2)].
Public Information from the FDA and Medscape
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Cite this: Drug Safety Warnings and Updates: April-June 2018 - Medscape - Sep 10, 2018.
