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.*
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Ophthalmologic | - Obtain baseline ophthalmology examination.
- Repeat ophthalmology examination annually.
| - If abnormal, obtain specialty evaluation to rule out alternative etiologies.
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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.
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Liver | - 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.
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