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U.S. Department of Health and Human Services


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Rituxan (rituximab) Oct 2004

Audience: Oncologists, hematologists and other healthcare professionals

Biogen Idec and Genentech notified healthcare professionals of revisions to the WARNINGS section of the prescribing information due to reports of Hepatitis B virus (HBV) reactivation with fulminant hepatitis, hepatic failure, and death in some patients with hematologic malignancies. Persons at high risk of HBV infection should be screened before initiation of Rituxan. Carriers of hepatitis B should be closely monitored for clinical and laboratory signs of active HBV infection and for signs of hepatitis during and for up to several months following Rituxan therapy.

[July 12, 2004 - Letter - Genentech/Biogen Idec]