FDA: Boxed Warning – Arzerra (ofatumumab) and Rituxan (rituximab)

The U.S. Food and Drug Administration (FDA) has approved 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.  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.

Read the source article at fda.gov