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Published On: Thu, Sep 26th, 2013

FDA updates ‘box warning’ for Arzerra and Rituxan to include Hepatitis B reactivation risk

The US Food and Drug Administration (FDA) announced Wednesday the approval of changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection.

 

Hepatitis B virions Image/CDC

Hepatitis B virions
Image/CDC

The affected drugs Arzerra and Rituxan are used  to treat chronic lymphocytic leukemia (CLL) in patients who have further disease after treatment with the anti-cancer drugs fludarabine and alemtuzumab, and  to treat non-Hodgkin’s lymphoma and CLL, respectively.

In patients with prior HBV infection, HBV reactivation may occur when the body’s immune system is impaired. HBV reactivation has occurred in patients with prior HBV exposure who are later treated with the above drugs. 

Some cases have resulted in fulminant hepatitis, hepatic failure, and death.

The FDA notes that  the risk is already described in the warnings and precautions section of the label for both drugs but that cases of reactivation continue to occur and some patients have died. Now the information will be placed in a black box, indicating the most serious type of risk.

The federal drug safety agency advises physicians to screen all patients for HBV infection before starting treatment with Arzerra or Rituxan by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) to decrease the risk of HBV reactivation.

In addition, they recommend that health care providers consult with hepatitis experts concerning the monitoring and use of HBV antiviral therapy, to monitor patients with evidence of prior HBV infection for clinical and laboratory signs of hepatitis B or HBV reactivation and if a patient develops reactivation, to discontinue use of the drug and initiate HBV treatment.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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