platelet counts <50 x 109/L;

known hypersensitivity to deferasirox or any component of Exjade.
5 WARNINGS AND PRECAUTIONS
5.1 Renal
Acute renal failure, fatal in some patients and requiring dialysis in others, has been reported following the postmarketing use of Exjade (deferasirox). Most fatalities occurred in patients with multiple comorbidities and who were in advanced stages of their hematological disorders. Monitor serum creatinine and/or creatinine clearance in patients who: are at increased risk of complications, have preexisting renal conditions, are elderly, have comorbid conditions, or are receiving medicinal products that depress renal function. Closely monitor the renal function of patients with creatinine clearances between 40 and less than 60 mL/min, particularly in situations where patients have additional risk factors that may further impair renal function such as concomitant medications, dehydration, or severe infections.

Assess serum creatinine and/or creatinine clearance in duplicate before initiating therapy to establish a reliable pretreatment baseline, due to variations in measurements. Monitor serum creatinine and/or creatinine clearance monthly thereafter. In patients with additional renal risk factors (see above), monitor serum creatinine and/or creatinine clearance weekly during the first month after initiation or modification of therapy and monthly thereafter.

Consider dose reduction, interruption, or discontinuation for increases in serum creatinine. If there is a progressive increase in serum creatinine beyond the age-appropriate upper limit of normal, interrupt Exjade use. Once the creatinine has returned to within the normal range, therapy with Exjade may be reinitiated at a lower dose followed by gradual dose escalation, if the clinical benefit is expected to outweigh potential risks [see Dose Modifications (2.2)].

In the clinical studies, for increases of serum creatinine on 2 consecutive measures (>33% in patients >15years of age or >33% and greater than the age-appropriate upper limit of normal in patients <15years of age), the daily dose of Exjade was reduced by 10mg/kg. Patients with baseline serum creatinine above the upper limit of normal were excluded from clinical studies.

In the clinical studies, Exjade-treated patients experienced dose-dependent increases in serum creatinine. These increases occurred at a greater frequency compared to deferoxamine-treated patients (38% vs. 14%, respectively, in Study1 and 36% vs 22%, respectively, in Study 3). Most of the creatinine elevations remained within the normal range [see Adverse Reactions (6.1)]. There have also been reports of renal tubulopathy in patients treated with Exjade. The majority of these patients were children and adolescents with ß-thalassemia and serum ferritin levels <1500 mcg/L.

5.2 Hepatic Dysfunction and Failure
Avoid the use of Exjade in patients with severe (Child-Pugh C) hepatic impairment. For patients with moderate (Child-Pugh B) hepatic impairment, a 50% reduction in the starting dose is recommended [see Dosage and Administration (2.2), and Use in Specific Populations (8.7)]. Closely monitor patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment for efficacy and adverse reactions that may require dose titration.

In Study1, 4patients discontinu