Are there any special considerations for patients with hepatic impairment?
In Study 1, 4 patients discontinued EXJADE because of hepatic abnormalities (drug-induced hepatitis in 2 patients and increased serum transaminases in 2 additional patients). There have been postmarketing reports of hepatic failure, some with a fatal outcome, in patients treated with EXJADE. Most of these events occurred in patients greater than 55 years. Most reports of hepatic failure involved patients with significant comorbidities, including liver cirrhosis and multi-organ failure. Serum transaminases and bilirubin should be monitored before the initiation of treatment, every 2 weeks during the first month and monthly thereafter. Consider dose modifications or interruption of treatment for severe or persistent elevations.
