• That Exjade causes rises in serum creatinine in some patients o The need to monitor serum creatinine • On two occasions prior to initiation of treatment • Every week during the first month of initiation of treatment or after modification of therapy • Monthly thereafter o The need to reduce by 10 mg/ kg the dose if serum creatinine rises: • Adults: > 33% above baseline and creatinine clearance< LLN (90 ml/min) • Paediatrics: either > ULN or creatinine clearance falls to < LLN o The need to interrupt treatment if serum creatinine rises: • Adults and paediatrics: > 33% above baseline or creatinine clearance < LLN (90 ml/min) o The need to consider renal biopsy: • When serum creatinine is elevated and if another abnormality has been detected (eg. proteinuria, signs of Fanconi’s Syndrome).