Tevimbra 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.

Programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies can cause immune-mediated adverse reactions, which may be severe or fatal. Immune-mediated adverse reactions can occur in any organ system or tissue at any time after starting therapy. This may be considered when using PD-1/PD-L1 blocking antibodies in patients with immune system disorders (e.g., ulcerative colitis, Crohn's disease, lupus) or with conditions affecting the nervous system (e.g., myasthenia gravis, Guillain-Barre syndrome). It is recommended to monitor patients closely for signs/symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions.

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. This may be considered when using PD-1/PD-L1 blocking antibodies in patients who have received a solid organ or other transplant.

Tislelizumab can cause immune-mediated pneumonitis, which can be fatal. The incidence of immune-mediated pneumonitis was higher in patients treated with other programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies who received prior radiation therapy in the chest area. This may be considered when using tislelizumab in patients who have received thoracic radiation.

The effect of severe liver dysfunction (total bilirubin greater than 3 times the upper limit of normal and any AST [estimated by National Cancer Institute criteria]) on the pharmacokinetics of tislelizumab is unknown.

The effect of severe renal dysfunction (CrCl 15 to 29 mL/min [estimated by Cockcroft-Gault]) or end-stage renal disease (CrCl less than 15 mL/min) on the pharmacokinetics of tislelizumab is unknown.