Drug Interaction Report

ADJUST DOSING INTERVAL: Sickle cell disease (SCD) modifying agents (e.g., crizanlizumab, voxelotor, and L-glutamine) may affect the manufacturing and therapeutic efficacy of the autologous genome edited hematopoietic stem cell-based gene therapy, lovotibeglogene autotemcel. The mechanism of this interaction is unknown. Hematopoietic stem cell mobilization is required to obtain the CD34+ cells needed for lovotibeglogene autotemcel production, followed by myeloablative conditioning prior to the lovotibeglogene autotemcel infusion. Clinical data on the interaction potential of crizanlizumab, voxelotor and L-glutamine with mobilization and conditioning agents are unavailable. Additionally, there are no available clinical data evaluating the use of crizanlizumab, voxelotor and L-glutamine after the administration of lovotibeglogene autotemcel.

MANAGEMENT: The manufacturer of lovotibeglogene autotemcel recommends the discontinuation of SCD modifying agents voxelotor, crizanlizumab and L-glutamine at least 2 months prior to the start of HSC mobilization, and at least 2 months prior to myeloablative conditioning. The manufacturer does not provide guidance on the use of SCD modifying agents after administration of the lovotibeglogene autotemcel infusion.