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Alert Number 49

Rituxan Warning

October 11, 2004

We seem to be getting a barrage of adverse effect warnings in the last few weeks. I was going to send out an alert with reference to Remicade, the rheumatic arthritis drug, when this more important warning came along.

This latest one to hit the fan is the warning below regarding the risk of hepatitis B virus reactivation during Rituxan therapy. This is not good news for us, many CLL patients have come to depend on Rituxan, either as single agent on in combination with other drugs.

Most of us are familiar with the risk of CMV (cytomegalovirus) reactivation upon use of Campath. Similar viral reactivations after Rituxan therapy have not been considered to be a high risk factor, up to now. I will dig into this a little more and report back with the details. In the mean while, I guess this new report confirms the old saying, there is no free lunch, at least not as far as cancer therapy is concerned. Several articles on this site detail profiles of popular therapies such as RF, F, FRC, Campath, etc., comparing the risks and rewards associated with each of them. While it is not easy to weigh the pros and cons of each therapy, it sure the beats the alternative of walking into them blind. Remember, the life you save may well be your own.

Be well,


Press Report

Rituxan May Be Associated With HBV Reactivation and Fulminant Hepatitis

Yael Waknine

Medscape 2004. 2004 WebMD Inc.

Oct. 9, 2004 The U.S. Food and Drug Administration (FDA), Biogen Idec, Inc., and Genentech, Inc., have warned healthcare professionals via letter of postmarketing clinical safety reports of hepatitis B virus (HBV) reactivation along with fulminant hepatitis, hepatic failure, and death in some patients with hematologic malignancies taking rituximab (Rituxan) therapy, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

Rituximab is indicated in the treatment of patients with relapsed or refractory low-grade or follicular CD20-positive B-cell non-Hodgkin's lymphoma.

According to the letter, the majority of patients affected received rituximab in combination with chemotherapy. Median time to diagnosis was four months after the initial dose of rituximab and approximately one month after the last dose.

The FDA recommends that patients at high risk of HBV infection be screened before initiation of rituximab therapy. Hepatitis B carriers should be closely monitored for clinical and laboratory signs and symptoms of active HBV infection during rituximab therapy and for several months thereafter.

Rituximab and concomitant chemotherapy should be discontinued in patients developing viral hepatitis, and appropriate treatment including antiviral therapy initiated. The FDA notes that insufficient information is available concerning the safety of resuming rituximab therapy in these patients.

Adverse events related to use of rituximab should be reported to Genentech Drug Safety at 1-888-835-2555. Alternatively, this information can be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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