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Prescribing Changes for Two Anti-Cancer Drugs

Information highlights risk of hepatitis B reactivation (September 25)

The FDA has approved changes to the prescribing information for the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab, GlaxoSmithKline) and Rituxan (rituximab, Genentech/Biogen IDEC) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels also will include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk.

Both Arzerra and Rituxan are used to treat certain cancers of the blood and lymph system. Rituxan is also approved to treat other medical conditions, including rheumatoid arthritis. Both drugs suppress the body’s immune system.

In patients with prior HBV infection, HBV reactivation may occur when the body’s immune system is impaired. This infection can cause serious liver problems, including liver failure and death. Reactivation can occur in patients who previously had HBV infection that was clinically resolved, but who later require therapy for a condition such as cancer.

When a treatment is given that can impair the body’s immune system, the previous HBV infection can again become an active infection. The initial HBV infection may occur without obvious signs of liver disease, and it may remain dormant in liver tissue. Therefore, screening for evidence of prior exposure is necessary to assess reliably the risk of HBV reactivation, the FDA says.

The risk of HBV reactivation is already described in the Warnings and Precautions section of the labels for both drugs; however, cases continue to occur, including deaths, prompting the FDA to examine this risk further for current evidence that may aid in recognition and a reduction in the risk.

HBV reactivation is being added to the existing Boxed Warning of the Rituxan label, and a new Boxed Warning is being created for the Arzerra label to describe the risk. The Warnings and Precautions section also is being revised for each drug to express new recommendations.

Source: FDA; September 25, 2013.

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