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