Monitor Treatment for Optimal Results¹

• 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 paediatric 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’s 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