Home > About EXJADE > Dosing > Transfusion–Dependent Conditions

Monitor Treatment for Optimal Results and Safety

Recommended monitoring during EXJADE treatment
Baseline In the first month after
initiation of EXJADE
Monthly Yearly
SF
Serum creatinine 2X Weekly1
Creatinine clearance and/or plasma cystatin C 2X Weekly1
Proteinuria
Serum transaminases,
bilirubin, alkaline phosphatase
Every 2 Weeks
Body weight, height,
and sexual development
pediatric patients)
Auditory/ophthalmic testing
(including fundoscopy)
Other markers of renal
tubular function:
(such as glycosuria in non-
diabetics and low levels of
serum potassium,
phosphate, magnesium or
urate, phosphaturia,
aminoaciduria)
As needed As needed As needed As needed

1Also applies to first month after any dose modification.

Drag left on above table to view complete data.

  • It is recommended that serum ferritin be monitored every month and that the dose of EXJADE be adjusted, if necessary, every 3 to 6 months based on the trends in serum ferritin
  • Dose adjustments may be made in steps of 5 to 10 mg/kg and are to be tailored to the individual patient's response and therapeutic goals (maintenance or reduction of iron burden)
  • In patients not adequately controlled with doses of 30 mg/kg (eg, serum ferritin levels persistently above 2,500 µg/l and not showing a decreasing trend over time), doses of up to 40 mg/kg may be considered
  • If only very poor haemosiderosis control is achieved at doses up to 30 mg/kg, a further increase (to a maximum of 40 mg/kg) may not achieve satisfactory control, and alternative treatment options may be considered
  • If no satisfactory control is achieved at doses above 30 mg/kg, treatment at such doses should not be maintained and alternative treatment options should be considered whenever possible
  • Doses above 40 mg/kg are not recommended because there is only limited experience with doses above this level
  • If serious hypersensitivity reactions (such as anaphylaxis and angioedema) occur, EXJADE should be discontinued and appropriate medical intervention instituted
  • If serum ferritin falls consistently below 500 µg/L, an interruption of treatment should be considered
  • For adult patients, the daily dose may be reduced by 10 mg/kg if a rise in serum creatinine by >33% above the average of the pre-treatment measurements and estimated creatinine clearance decreases below the lower limit of the normal range (<90 mL/min) are seen at two consecutive visits, and cannot be attributed to other causes. For pediatric patients, the dose may be reduced by 10 mg/kg if estimated creatinine clearance decreases below the lower limit of the normal range (<90 mL/min) and/or serum creatinine levels rise above the age-appropriate upper limit of normal at two consecutive visits
  • After a dose reduction, for adult and pediatric patients, treatment should be interrupted if a rise in serum creatinine >33% above the average of the pre-treatment measurements is observed and/or the calculated creatinine clearance falls below the lower limit of the normal range. Treatment may be reinitiated depending on the individual clinical circumstances
  • Renal tubulopathy has been mainly reported in children and adolescents with β-thalassemia treated with EXJADE. Tests for proteinuria should be performed monthly. As needed, additional markers of renal tubular function (eg, glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, phosphaturia, aminoaciduria) may also be monitored. Dose reduction or interruption may be considered if there are abnormalities in levels of tubular markers and/or if clinically indicated
  • If, despite dose reduction and interruption, the serum creatinine remains significantly elevated and there is also persistent abnormality in another marker of renal function (eg, proteinuria, Fanconi‚Äôs Syndrome), the patient should be referred to a renal specialist, and further specialized investigations(such as renal biopsy) may be considered
  • It is recommended that serum transaminases, bilirubin and alkaline phosphatase be checked before the initiation of treatment, every 2 weeks during the first month and monthly thereafter. If there is a persistent and progressive increase in serum transaminase levels that cannot be attributed to other causes, EXJADE should be interrupted. Once the cause of the liver function test abnormalities has been clarified or after return to normal levels, cautious re-initiation of treatment at a lower dose followed by gradual dose escalation may be considered