Hyaluronidase/nivolumab Disease Interactions

There are no data available on the use of nivolumab-containing products in patients with severe hepatic impairment or autoimmune liver disease. No dose adjustment is recommended for patients with mild or moderate hepatic impairment during use of IV nivolumab; data not available for subcutaneous nivolumab. Monitor liver enzymes at baseline and periodically during therapy. Therapy with nivolumab-containing products may cause immune-mediated hepatitis and/or hepatotoxicity.

Use of nivolumab-containing products can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

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 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.