Drug Interaction Report

ADJUST DOSING INTERVAL: The administration of inactivated, killed, or otherwise noninfectious vaccines has not been studied in patients during or following administration of autologous hematopoietic stem cell (HSC)-based gene therapy (e.g., exagamglogene autotemcel, lovotibeglogene 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 diminished or suboptimal immunologic response to the vaccine. 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. Clinical data specific to exagamglogene autotemcel and lovotibeglogene autotemcel are not available.

MANAGEMENT: The safety and efficacy of immunizations with inactivated, killed, or otherwise noninfectious vaccines during or following HSC-based gene therapy with exagamglogene autotemcel or lovotibeglogene autotemcel has not been evaluated. Until more information is available, local vaccination guidelines specific to post-autologous HSCT and functional asplenia should be consulted for recommendations on vaccines. For example, the Advisory Committee on Immunization Practices (ACIP) recommends initiating revaccination with many of these vaccines approximately 6 months after HSCT. The recommendations may differ based on age, immune status, presence of graft-versus-host disease, and specific vaccination being considered.

ADJUST DOSING INTERVAL: The administration of inactivated, killed, or otherwise noninfectious vaccines has not been studied in patients during or following administration of autologous hematopoietic stem cell (HSC)-based gene therapy (e.g., exagamglogene autotemcel, lovotibeglogene 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 diminished or suboptimal immunologic response to the vaccine. 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. Clinical data specific to exagamglogene autotemcel and lovotibeglogene autotemcel are not available.

MANAGEMENT: The safety and efficacy of immunizations with inactivated, killed, or otherwise noninfectious vaccines during or following HSC-based gene therapy with exagamglogene autotemcel or lovotibeglogene autotemcel has not been evaluated. Until more information is available, local vaccination guidelines specific to post-autologous HSCT and functional asplenia should be consulted for recommendations on vaccines. For example, the Advisory Committee on Immunization Practices (ACIP) recommends initiating revaccination with many of these vaccines approximately 6 months after HSCT. The recommendations may differ based on age, immune status, presence of graft-versus-host disease, and specific vaccination being considered.

ADJUST DOSING INTERVAL: The administration of inactivated, killed, or otherwise noninfectious vaccines has not been studied in patients during or following administration of autologous hematopoietic stem cell (HSC)-based gene therapy (e.g., exagamglogene autotemcel, lovotibeglogene 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 diminished or suboptimal immunologic response to the vaccine. 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. Clinical data specific to exagamglogene autotemcel and lovotibeglogene autotemcel are not available.

MANAGEMENT: The safety and efficacy of immunizations with inactivated, killed, or otherwise noninfectious vaccines during or following HSC-based gene therapy with exagamglogene autotemcel or lovotibeglogene autotemcel has not been evaluated. Until more information is available, local vaccination guidelines specific to post-autologous HSCT and functional asplenia should be consulted for recommendations on vaccines. For example, the Advisory Committee on Immunization Practices (ACIP) recommends initiating revaccination with many of these vaccines approximately 6 months after HSCT. The recommendations may differ based on age, immune status, presence of graft-versus-host disease, and specific vaccination being considered.

ADJUST DOSING INTERVAL: The administration of inactivated, killed, or otherwise noninfectious vaccines has not been studied in patients during or following administration of autologous hematopoietic stem cell (HSC)-based gene therapy (e.g., exagamglogene autotemcel, lovotibeglogene 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 diminished or suboptimal immunologic response to the vaccine. 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. Clinical data specific to exagamglogene autotemcel and lovotibeglogene autotemcel are not available.

MANAGEMENT: The safety and efficacy of immunizations with inactivated, killed, or otherwise noninfectious vaccines during or following HSC-based gene therapy with exagamglogene autotemcel or lovotibeglogene autotemcel has not been evaluated. Until more information is available, local vaccination guidelines specific to post-autologous HSCT and functional asplenia should be consulted for recommendations on vaccines. For example, the Advisory Committee on Immunization Practices (ACIP) recommends initiating revaccination with many of these vaccines approximately 6 months after HSCT. The recommendations may differ based on age, immune status, presence of graft-versus-host disease, and specific vaccination being considered.