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Boxed warning for potential HBV reactivation added to Arzerra, Rituxan labeling
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The FDA has approved the addition of a boxed warning and labeling changes for two anti-cancer medications to reflect their potential for hepatitis B virus reactivation, according to a MedWatch release.
Arzerra (ofatumumab, GlaxoSmithKline) is intended for use in patients with chronic lymphocytic leukemia (CLL), among patients with persistent cancer after therapy with fludarabine and alemtuzumab. Rituxan (rituximab, Genentech) is a therapy for CLL, non-Hodgkin’s lymphoma and conditions that include microscopic polyangiitis, granulomatosis with polyangiitis and rheumatoid arthritis.
These drugs, along with other CD20-directed cytolytic antibodies, can induce reactivation of hepatitis B among patients with previous HBV infection and impaired immune systems, according to the release. Information about potential HBV reactivation will be added to an existing Rituxan boxed warning, while Arzerra labeling will include a new boxed warning.
The warnings follow 109 reports of fatal acute liver injury related to HBV among patients who received Arzerra (n=3) or Rituxan (n=106) from market approval to August 2012, including 32 incidents with sufficient data to link the injury to HBV reactivation.
The FDA recommended that clinicians screen for HBV in all patients before initiation of therapy with Arzerra or Rituxan and consult with hepatitis experts about antiviral therapy for HBV in the event that a patient may be at risk of HBV reactivation while on either medication. Patients with prior HBV infection should be monitored for reactivation during therapy and several months after treatment completion. If reactivation occurs, HBV therapy should be initiated and treatment with Arzerra or Rituxan, along with any chemotherapy, should be immediately discontinued.
Patients should discuss previous severe infection, including HBV, with their physicians before treatment initiation with either drug. The FDA encouraged both patients and health care professionals to report any treatment-related side effects to the MedWatch Safety Information and Adverse Event Reporting Program.