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تعداد آیتم قابل مشاهده باقیمانده: 4

Monitoring and management of deferasirox adverse events

Monitoring and management of deferasirox adverse events
Adverse effect Monitoring Actions
Dermatologic
  • Rash, often transient
  • Severe skin reaction (rare)
  • History and physical examination with each visit.
  • For mild or moderate rash, no action needed.
  • For severe rash, hold deferasirox. Once rash resolves, consider restarting at lower dose (50% reduction) with gradual dose escalation.
  • For severe and potentially life-threatening skin reactions (SJS/TEN, DRESS), immediately discontinue and do not reintroduce therapy.*
Ophthalmologic
  • Retinopathy
  • Obtain baseline ophthalmology examination.
  • Repeat ophthalmology examination annually.
  • If abnormal, obtain specialty evaluation to rule out alternative etiologies.
Kidney
  • Reduced kidney function
  • Renal tubular dysfunction
  • Proteinuria
  • Obtain serum creatinine, bicarbonate, potassium, and phosphorus at baseline and every 3 to 4 weeks.
  • Obtain urinalysis with urine protein to creatinine ratio at baseline and at least every 3 months.
  • Creatinine
    • If increased by >33% at 2 consecutive visits, reduce dose by 25%.
    • If above the upper limit of normal, reduce dose by 50% and after normalization of creatinine, increase gradually as tolerated.
    • If >2 times the upper limit of normal, hold deferasirox. Once creatinine normalizes, may consider restarting at a lower dose (50% reduction) with close monitoring.
  • Potassium, phosphorus, bicarbonate
    • If any are below the lower limit of normal on 2 consecutive visits, obtain urinary studies to evaluate for proximal tubular dysfunction and lower dose by 25%.
    • For severe deficits, hold deferasirox until recovery. Provide supplements as needed. Once resolved, may consider restarting at 50% dose reduction with close monitoring (may recur).
  • Urine protein
    • Confirm any urine dipstick protein of ≥2+ with spot urine protein to creatinine ratio.
    • If ratio >0.5 grams/gram on 2 consecutive samples 1 month apart, lower dose by 50%.
    • Consider nephrology evaluation for other causes of proteinuria.
Liver
  • Increased transaminases
  • Obtain ALT and direct bilirubin at baseline, 2 weeks after starting, and every 3 to 4 weeks thereafter.
  • If normal at baseline and ALT increases to >3 times the upper limit of normal on 2 consecutive tests, lower the dose by 25%.
  • If normal at baseline and ALT increases >10 times the upper limit of normal or direct bilirubin increases >2 times the upper limit of normal, hold therapy and restart at a lower dose (25 to 50% of starting dose) once ALT and direct bilirubin normalize.
  • If ALT is abnormal at baseline and increases >2 times baseline and >5 times the upper limit of normal in a patient with very elevated liver iron concentration or chronic viral hepatitis, lower dose by 50%; if no improvement in ALT after 1 month, hold the dose.
  • If no improvement in ALT after holding deferasirox for 1 month, may resume at the original dose with close monitoring. If the elevation persists after drug discontinuation, it is presumed not to be due to deferasirox.

Adverse effects of deferasirox may be worse with dehydration. Encourage good hydration and consider withholding doses during significant vomiting/diarrheal illness or fever/increased insensible loss.

Deferasirox can be given as the following formulations:

  • Dispersible tablet for oral suspension (Exjade).
  • Film-coated tablet (Jadenu).
  • Granules (Jadenu), which can be sprinkled on soft food (applesauce, yogurt) and may be easier for young children.

Refer to UpToDate for details of chelator selection, dosing, and adverse effects.

ALT: alanine aminotransferase; DRESS: drug reaction with eosinophilia and systemic symptoms; SJS/TEN: Stevens-Johnson syndrome/toxic epidermal necrolysis.

* Refer to UpToDate for other aspects of management of SJS/TEN and DRESS.

Reference:
  1. Ware HM, Kwiatkowski JL. Evaluation and treatment of transfusional iron overload in children. Pediatr Clin North Am 2013; 60:1393.

Adapted from: Monitoring Deferasirox Therapy. Thalassemia Management Checklists. https://thalassemia.org/files/galleries/Monitoring-Deferasirox-Therapy.pdf (Accessed on May 9, 2025).

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