Table 1. Adverse Reactions Occurring in >5% of Exjade-treated Patients in Study1 and Study 3*  Study 1 (ß-Thalassemia)
Study 3 (Sickle Cell Disease)
Preferred Term EXJADE
N=296
n (%) Deferoxamine
N=290
n (%) EXJADE
N=132
n (%) Deferoxamine
N=63
n (%)
Abdominal Pain** 63 (21.3) 41 (14.1) 37 (28.0) 9 (14.3)
Diarrhea 35 (11.8) 21 (7.2) 26 (19.7) 3 (4.8)
Creatinine Increased*** 33 (11.1) 0 (0) 9 (6.8) 0
Nausea 31 (10.5) 14 (4.8) 30 (22.7) 7 (11.1)
Vomiting 30 (10.1) 28 (9.7) 28 (21.2) 10 (15.9)
Rash 25 (8.4) 9 (3.1) 14 (10.6) 3 (4.8)
*Adverse reaction frequencies are based on adverse events reported regardless of relationship to study drug.
** Includes ‘abdominal pain’, ‘abdominal pain lower’, and ‘abdominal pain upper’ which were reported as adverse events.
*** Includes ‘blood creatinine increased’ and ‘blood creatinine abnormal’ which were reported as adverse events. Also see Table2.

In Study1, a total of 113(38%) patients treated with Exjade had increases in serum creatinine >33% above baseline on 2 separate occasions (Table2) and 25(8%) patients required dose reductions. Increases in serum creatinine appeared to be dose related [see Warnings and Precautions(5.1)]. In this study, 17(6%) patients treated with Exjade developed elevations in SGPT/ALT levels >5times the upper limit of normal at 2 consecutive visits. Of these, 2patients had liver biopsy proven drug-induced hepatitis and both discontinued Exjade therapy [see Warnings and Precautions(5.2)]. Anadditional 2 patients, who did not have elevations in SGPT/ALT >5times the upper limit of normal, discontinued Exjade because of increased SGPT/ALT. Increases in transaminases did not appear to be dose related. Adverse reactions that led to discontinuations included abnormal liver function tests (2patients) and drug-induced hepatitis (2patients), skin rash, glycosuria/proteinuria, Henoch Schönlein purpura, hyperactivity/insomnia, drug fever, and cataract (1patient each).

In Study3, a total of 48(36%) patients treated with Exjade had increases in serum creatinine >33% above baseline on 2 separate occasions (Table2) [see Warnings and Precautions(5.1)]. Of the patients who experienced creatinine increases in Study 3, 8 Exjade-treated patients required dose reductions. In this study, 5patients in the Exjade group developed elevations in SGPT/ALT levels >5times the upper limit of normal at 2 consecutive visits and 1 patient subsequently had Exjade permanently discontinued. Four additional patients discontinued Exjade due to adverse reactions with a suspected relationship to study drug, including diarrhea, pancreatitis associated with gallstones, atypical tuberculosis, and skin rash.

Table 2. Number (%) of Patients with Increases in Serum Creatinine or SGPT/ALT in Study1 andStudy 3 
Study 1 (ß-Thalassemia)
Study 3 (Sickle Cell Disease)

Laboratory Parameter EXJADE
N=296
n (%) Deferoxamine
N=290
n (%) EXJADE
N=132
n (%) Deferoxamine
N=63
n (%)
Serum Creatinine
Creatinine increase >33% and <ULN at 2 consecutive postbaseline visits 113 (38.2) 41 ( 14.1) 48 (36.4) 14 (22.2)
Creatinine increase >33% and >ULN at 2 consecutive postbaseline visits 7 (2.4) 1 (0.3) 3 (2.3) 2 (3.2)
SGPT/ALT
SGPT/ALT >5 x ULN at 2 postbaseline visits 25 (8.4