Guest guest Posted March 20, 2011 Report Share Posted March 20, 2011 It is important that CLL patients taking ANY treatment that includes Rituxan (and possibly Arzerra) be screened for the Hepatitis B virus prior to treatment. Section 5.5 of the drug label states: Hepatitis B Virus (HBV) Reactivation Hepatitis B virus (HBV) reactivation with fulminant hepatitis, hepatic failure, and death can occur in patients with hematologic malignancies treated with Rituxan. The median time to the diagnosis of hepatitis was approximately 4 months after the initiation of Rituxan and approximately one month after the last dose. Screen patients at high risk of HBV infection before initiation of Rituxan. Closely monitor carriers of hepatitis B for clinical and laboratory signs of active HBV infection for several months following Rituxan therapy. Discontinue Rituxan and any concomitant chemotherapy in patients who develop viral hepatitis, and institute appropriate treatment including antiviral therapy. Insufficient data exist regarding the safety of resuming Rituxan in patients who develop hepatitis subsequent to HBV reactivation. Source FDA: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5311lbl.pdf Quote Link to comment Share on other sites More sharing options...
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