Drug Interaction Report

GENERALLY AVOID: The administration of vaccines or oncolytic immunotherapy containing live, attenuated virus or bacteria has not been studied in patients receiving autologous hematopoietic stem cell (HSC)-based gene therapy (e.g., atidarsagene autotemcel, elivaldogene autotemcel). In general, patients who undergo myeloablative conditioning followed by autologous HSC-based gene therapy have altered immune competence, which may be associated with a risk of disseminated infection due to enhanced replication of vaccine virus or bacteria, an increase in vaccine adverse reactions, and/or a decreased or suboptimal immunologic response to the vaccine(s) or oncolytic immunotherapy. The myeloablative therapy performed prior to HSC transplant (HSCT) is believed to gradually remove immune memory acquired from previous vaccinations, with antibody titers to vaccine-preventable diseases decreasing 1 to 4 years after autologous HSCT if the recipient is not revaccinated.

MANAGEMENT: The administration of vaccines or oncolytic immunotherapy containing live, attenuated virus or bacteria is not recommended in the 6 weeks prior to the start of myeloablative conditioning and until there is demonstrated hematological recovery after the receipt of either atidarsagene autotemcel or elivaldogene autotemcel. Local vaccination guidelines specific to post-autologous HSCT and prescribing information for individual vaccines should be consulted for further guidance. For example, the Advisory Committee on Immunization Practices (ACIP) has specific recommendations for live vaccines which vary between not being recommended and waiting at least 24 months after HSCT. Other variabilities that should also be considered include the presence of graft-versus-host disease and immunocompetence.