Tislelizumab Disease Interactions

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. It is recommended to follow patients closely for evidence of transplant-related complications and intervene promptly. The benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody before or after an allogeneic HSCT should be considered.

Solid organ transplant rejection and other transplant (including corneal graft) rejection have been reported with the use of programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies. Care should be exercised when using PD-1/PD-L1 blocking antibodies in patients who have received a solid organ or other transplant.

Tislelizumab is a monoclonal antibody and may cause severe and fatal immune-mediated adverse reactions in any organ system or tissue (e.g., pneumonitis, colitis, hepatitis, endocrinopathies, renal dysfunction and others). The incidence of immune-mediated pneumonitis was shown to be higher in patients who received prior radiation therapy in the chest. In general, patients should be monitored closely for signs or symptoms that may indicate an underlying immune-mediated adverse reaction. Liver enzymes, creatinine, and thyroid function should be evaluated at baseline and during treatment. Medical treatment should be started promptly, including consultation with a specialist as appropriate in case of an immune-mediated adverse reaction.

The effect of severe liver dysfunction (total bilirubin greater than 3 times the upper limit of normal and any AST) on the pharmacokinetics of tislelizumab is unknown.

The effect of severe renal dysfunction (CrCl between 15 and 29 mL/min) and end-stage renal disease (CrCl less than 15 mL/min) on the pharmacokinetics of tislelizumab is unknown.