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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Arzerra Gets a New Boxed Warning

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The anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) recently got an upgrade to their boxed warning labels, adding information about the potential risk for reactivation of hepatitis B infection, in patients who have previously suffered from such infection. Along with the hepatitis warning, the labels will also include additional recommendations for users, including screening, monitoring, and continued management of patients currently prescribed the medication.

Azerra is a drug used to treat chronic lymphocytic leukemia, and Rituxan is used to treat non-Hodgkin’s lymphoma and CLL. When used with other medications the drugs can also be used to treat arthirits, granulomatosis, and microscopic polyangiitis.

Patients which are on the two medications, and who have experienced a prior hepatitis B infection, may reactive the virus as the body’s immune system becomes impaired due to the anti-cancer drugs.

Reactivation may cause fulminant hepatitis, hepatic failure, and even death.

Patients are recommended to contact their healthcare professional if they are battling any severe infections while on the medication, and to increase monitoring for infection during treatment and several months after discontinuing the medication.

The FDA encourages patients to report any adverse effects immediately.