Interactions between Breyanzi and Cemiplimab

Cemiplimab has a major potential interaction with Autoimmune Disorders.

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 has a moderate potential interaction with Bone Marrow Transplantation.

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.

Cemiplimab has a moderate potential interaction with History, Radiation Therapy.

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.

The lisocabtagene maraleucel in Breyanzi has a major potential interaction with Infection.

Lisocabtagene maraleucel should not be administered to patients with active infection or inflammatory disorders. Monitor patients for signs or symptoms of infection and treat appropriately.

Cemiplimab has a moderate potential interaction with Infectious Gastroenteritis.

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.

The lisocabtagene maraleucel in Breyanzi has a moderate potential interaction with Infectious Hepatitis.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, such as lisocabtagene maraleucel. Screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing is advised. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.

Cemiplimab has a moderate potential interaction with Inflammatory Bowel Disease.

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 has a moderate potential interaction with Liver Disease.

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 has a moderate potential interaction with Organ Transplant.

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.

Cemiplimab has a moderate potential interaction with Renal 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.