Drug Interactions between tisagenlecleucel and Ziextenzo

ADJUST DOSING INTERVAL: Concurrent administration of tisagenlecleucel and hematopoietic growth factors may interfere with one another's pharmacologic effects, since the former targets B-cell lymphoblasts and the latter stimulate myeloid cell proliferation. Additionally, myeloid growth factors have the potential to worsen cytokine release syndrome (CRS) symptoms as CRS is directly related to in vivo T-cell expansion and production of T-cell effector cytokines such as granulocyte-macrophage colony-stimulating factor (GM-CSF). However, the clinical significance is unclear, and the data are conflicting. In one retrospective review comparing patients who had received another CD19-directed chimeric antigen receptor (CAR)-T cell therapy (axicabtagene ciloleucel), and granulocyte-colony stimulating factor (G-CSF), to those who received CAR-T cell therapy alone, the use of G-CSF prolonged the duration (8 days versus 4.5 days), but not the incidence or severity of CRS. Other retrospective studies have shown an association of poorer responses to CAR-T cell therapy and worsened overall survival in patients who received G-CSF after CAR-T cell therapy, though causality is unknown. On the other hand, one study in patients with refractory/relapsed B-cell lymphoma did not reveal an increased risk of experiencing CRS when G-CSF administration was started 5 days post-CAR-T cell therapy.

MANAGEMENT: The manufacturer recommends avoiding the use of myeloid growth factors, particularly granulocyte-macrophage colony-stimulating factor (GM-CSF), for 3 weeks following tisagenlecleucel administration or until cytokine release syndrome (CRS) has resolved. Some clinical guidelines advise against the use of GM-CSF following CAR-T cell therapy, but state that administration of G-CSF sooner than 3 weeks after CAR-T cell therapy may be appropriate in some situations. Relevant local protocols, national guidelines, and product labeling should be consulted for further information and recommendations.

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