Omidubicel
The product label of omidubicel recommends that patients be treated under the supervision of a physician experienced in the treatment of hematologic malignancies at centers with expertise in hematopoietic stem cell transplantation.
The product label contains several boxed warnings:
Infusion reactions: Fatal infusion reactions may occur. Individuals should be monitored during infusion and discontinue for severe reactions. The use of omidubicel is contraindicated for individuals with a known allergy to dimethyl sulfoxide, Dextran 40, gentamicin, human serum albumin, or bovine material.
Graft versus host disease (GVHD): Fatal GVHD may occur. The administration of immunosuppressive therapies may decrease the risk of GVHD.
Engraftment syndrome: Fatal engraftment syndrome may occur. Engraftment syndrome should be treated promptly with corticosteroids.
Graft failure: Fatal graft failure may occur. Patients should be monitored for hematopoietic recovery using laboratory evidence.
