Cemiplimab Disease Interactions

Cemiplimab can cause immune-mediated adverse reactions, which may be severe or fatal. Immune-mediated adverse reactions can occur in any organ system or tissue, can affect more than 1 body system simultaneously, and can occur at any time after starting therapy. Care should be exercised when using cemiplimab in patients with preexisting 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. Liver enzymes, creatinine, and thyroid function should be evaluated at baseline and periodically during therapy. If immune-mediated adverse reactions are suspected, appropriate workup should be started to exclude alternative etiologies (including infection). Medical management should be started promptly, including specialty consultation as appropriate. Cemiplimab should be withheld or permanently discontinued depending on severity.

Cemiplimab can cause immune-mediated colitis, with a primary component of diarrhea. CMV infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis treated with programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies; repeating infectious workup should be considered in these patients to exclude alternative etiologies. Cemiplimab should be withheld or permanently discontinued depending on severity of colitis.

Cemiplimab can cause immune-mediated hepatitis. Liver enzymes should be evaluated at baseline and periodically during therapy. Cemiplimab should be withheld or permanently discontinued depending on severity of hepatitis. Additionally, this drug has not been studied in patients with severe liver dysfunction (total bilirubin greater than 3 times the upper limit of normal [3 x ULN]); mild to moderate liver dysfunction (total bilirubin greater than 1 to 3 x ULN) had no clinically significant effect on the exposure of cemiplimab. Caution should be exercised when using cemiplimab in patients with liver dysfunction.

Cemiplimab can cause immune-mediated nephritis with renal dysfunction. Creatinine should be evaluated at baseline and periodically during therapy. Cemiplimab should be withheld or permanently discontinued depending on severity of nephritis. Additionally, renal dysfunction (CrCl at least 21 mL/min [determined by Cockcroft-Gault]) had no clinically significant effect on the exposure of cemiplimab. Care should be exercised when using cemiplimab in patients with renal dysfunction.

Cemiplimab can cause immune-mediated pneumonitis. In patients treated with other programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies, the incidence of pneumonitis was higher in patients with prior thoracic radiation. Care should be exercised when using cemiplimab in patients who have received thoracic radiation. Cemiplimab should be withheld or permanently discontinued depending on severity of pneumonitis.

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.

Myasthenic syndrome/myasthenia gravis (including exacerbation) has 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 with myasthenia gravis.

Solid organ transplant rejection has 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 transplant.