title: Hepatitis B reactivation and rituximab: a new boxed warning and considerations for solid organ transplantation.
abstract: Use of rituximab, a chimeric monoclonal antibody directed at the CD20 antigen, continues to increase in solid organ transplantation (SOT) for several off-label uses. In September 2013, the United States Food and Drug Administration (FDA) issued a Drug Safety Communication to oncology, rheumatology and pharmacy communities outlining a new Boxed Warning for rituximab. Citing 109 cases of fatal hepatitis B virus (HBV) reactivation in persons receiving rituximab therapy with previous or chronic HBV infection documented in their Adverse Event Reporting System (AERS), the FDA recommends screening for HBV serologies in all patients planned to receive rituximab and antiviral prophylaxis in any patient with a positive history of HBV infection. There is a lack of data pertaining to this topic in the SOT population despite an increase in off-label indications. Previous reports suggest patients receiving rituximab, on average, were administered six doses prior to HBV reactivation. Recommendations on prophylaxis, treatment and re-challenging patients with therapy after resolution of reactivation remain unclear. Based on data from the FDA AERS and multiple analyses in oncology, SOT providers utilizing rituximab should adhere to the FDA warnings and recommendations regarding HBV reactivation until further data are available in the SOT population.
authors.affiliation: Department of Pharmacy Services, Hartford Hospital, Hartford, CT.
authors.forename: S T
authors.initials: ST
authors.lastname: Martin
authors.forename: S M
authors.initials: SM
authors.lastname: Cardwell
authors.forename: M D
authors.initials: MD
authors.lastname: Nailor
authors.forename: S
authors.initials: S
authors.lastname: Gabardi
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D006509:Hepatitis B / Q000139:chemically induced* / Q000175:diagnosis / Q000821:virology; D006515:Hepatitis B virus / Q000187:drug effects; D006801:Humans; D016377:Organ Transplantation; D017410:Practice Guidelines as Topic; D011379:Prognosis; D012307:Risk Factors; D000069283:Rituximab; D014481:United States; D014486:United States Food and Drug Administration; D014775:Virus Activation / Q000187:drug effects*
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab
keywords: Hepatitis B virus; immunosuppression; rituximab; solid organ transplantation