NTDT2

EXJADE®: An established safety profile in NTDT

Most common drug-related adverse events1
Safety_Common drug-related adverse events

Data from THALASSA, a 1-year, prospective, randomized, double-blind, placebo-controlled phase 2 study in 166 patients with β-thalassemia intermedia, α-thalassemia, or HbE/β-thalassemia with liver iron concentration ≥5 mg Fe/g dw and serum ferritin >300 µg/l. Patients were randomized to EXJADE 5 mg/kg/day (n=55) or placebo (n=28) and EXJADE 10 mg/kg/day (n=55) or placebo (n=28).1

Liver transaminase and serum creatinine2

  • Elevations of liver transaminases >2 times the baseline and >5 times the upper limit of normal were reported in 1.8% of patients treated with 10 mg/kg/day of EXJADE
  • Three patients (5.5%) in the EXJADE 10 mg/kg/day cohort had 2 consecutive serum creatinine increases of >33% above baseline and above the upper limit of normal

Patients with renal impairment2

EXJADE has not been studied in patients with renal impairment and is contraindicated in patients with estimated creatinine clearance <60 ml/min.

Patients with hepatic impairment2

EXJADE is not recommended for patients with severe hepatic impairment (Child-Pugh class C). In patients with moderate hepatic impairment (Child-Pugh class B), the dose should be considerably reduced, followed by a progressive increase up to a limit of 50%, and EXJADE must be used with caution in such patients. Hepatic function in all patients should be monitored before treatment, every 2 weeks during the first month, and then every month.

SAFETY PROFILE ACROSS ANEMIAS

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