Rheumatology Drug Updates

Rituximab has recently received a boxed warning due to the associated risk of immunosuppressive-related hepatitis B virus (HBV) reactivation.⁸ Additional recommendations for screening, monitoring, and managing patients treated with rituximab and another immunosuppressive agent, ofatumumab, are also included in the revised label to decrease patient risk. After taking either of these two these immunosuppressive agents, some patients with prior HBV infection have developed fulminant hepatitis, hepatic failure, and have even died. To decrease the risk of HBV reactivation, the FDA recommends the following: 1) all patients to be treated with these agents be screened for HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) prior to therapy commencement; 2) when screening identifies patients at risk for HBV reactivation due to prior HBV infection, consult with hepatitis experts concerning use of antiviral (HBV) therapy and patient monitoring; 3) monitor high-risk patients taking rituximab for laboratory signs of HBV reactivation (e.g., elevated alanine aminotransferase and/or aspartate aminotransferase levels, elevated alkaline phosphatase levels, gamma-glutamyl transpeptidase levels, bilirubin levels, albumin levels, etc.) and clinical signs of HBV reactivation (e.g., nausea, intermittent mild-to-moderate right upper quadrant and epigastric pain, disordered gustatory and smell sensations, anorexia, myalgia, low-grade fever, fatigue, etc.). This should be done within the first several months of treatment.⁹ Reactivation has occurred several months after starting these immunosuppressive agents. If patients develop HBV reactivation, the immunosuppressive agent should be immediately discontinued, and HBV therapy should be started. At present, no recommendation can be made about resuming treatment with immunosuppressive agents.

Michele Kaufman is a freelance medical writer based in New York City, a pharmacist at New York Presbyterian–Lower Manhattan Hospital, and adjunct faculty at Touro College of Pharmacy.

References

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