Manufacturer: Biogen and Genentech
Indications: Rituximab is indicated for relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma and for diffuse, CD20-positive, large B-cell non-Hodgkin’s lymphoma in combination with CHOP (cyclo-phosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
Reason for FDA Intervention: Very rare cases (less than one adverse drug event per 10,000 treated patients) of hepatitis B virus (HBV) reactivation in association with rituximab therapy were reported internationally. Most patients received rituximab in combination with chemotherapy. Isolated cases have been reported in patients who either had evidence of antibodies against hepatitis B surface antigen before treatment or did not have any such antibodies. Reporting rates determined on the basis of spontaneously reported postmarketing adverse events are generally presumed to underestimate the risks associated with drug treatments. The median time to the diagnosis of hepatitis was approximately four months after the initiation of rituximab and approximately one month after the last dose. Label Change: HBV reactivation with fulminant hepatitis, hepatic failure, and death have been reported in some patients with hematological malignancies who received rituximab. Most patients received this drug in combination with chemotherapy.
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Persons at high risk for HBV infection should be screened before they begin rituximab therapy. 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 therapy.
If viral hepatitis develops, rituximab and any concomitant chemotherapy should be discontinued; appropriate treatment, including antiviral therapy, should be initiated. Whether it is safe to resume rituximab therapy in patients who develop hepatitis subsequent to HBV reactivation is unclear. Conclusion: Reactivation of HBV infection is a well-known complication in patients with chronic hepatitis B, especially in those receiving cytotoxic or immunosuppressive therapy. Non-Hodgkin’s lymphoma itself may be an independent risk factor for HBV reactivation. Carriers of hepatitis B, and patients with evidence of having recovered from hepatitis B infection, should be closely monitored for clinical and laboratory signs of active HBV infection and for signs of hepatitis during and up to one year following rituximab therapy.