Drug Interaction Report

ADJUST DOSING INTERVAL: Concurrent use of the autologous genome edited hematopoietic stem cell-based gene therapy lovotibeglogene autotemcel with myeloablative conditioning agents, such as busulfan, may lead to destruction of the newly edited stem cells. However, clinical data on the use of lovotibeglogene autotemcel before elimination of the myeloablative conditioning regimen are not available.

MANAGEMENT: The manufacturer recommends administering lovotibeglogene autotemcel no sooner than 48 hours after the last dose of the myeloablative conditioning regimen to allow for the elimination of the myeloablative conditioning agent from the body. Therapeutic drug monitoring of busulfan levels may be considered to confirm adequate washout prior to gene therapy administration.