Omidubicel-onlv

1 INDICATIONS AND USAGE OMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for the treatment of: adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infections. ( 1.1 ) adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning.

6 ADVERSE REACTIONS Hematological malignancies: The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion and hypersensitivity reactions. ( 6.1 ) SAA: The most common adverse reactions (incidence > 20%) are infections, hyperglycemia, skin rash, febrile neutropenia, immune thrombocytopenia, acute kidney injury, acute GvHD, hypertension, hypoxia, and infusion related reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gamida Cell at (844) 477-7478 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

8.1 Pregnancy Risk Summary There are no available data with OMISIRGE use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with OMISIRGE to assess whether it can cause fetal harm when administered to a pregnant woman. In Study 17-H-0091, one patient reported two pregnancies, one at 9 months and one at 3.5 years post-transplant. There were no reported birth complications or neonatal concerns. OMISIRGE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

WARNING: GRAFT VERSUS HOST DISEASE, INFUSION REACTIONS, AUTOIMMUNE CYTOPENIAS, GRAFT FAILURE, and ENGRAFTMENT SYNDROME Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD [ see Warnings and Precautions (5.1) ]. Infusion reactions: Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. 5 WARNINGS AND PRECAUTIONS Malignancies of donor origin: Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs after treatment with OMISIRGE, contact Gamida Cell at (844) 477-7478. ( 5.5 ) Transmission of serious infections: Monitor patients closely for serious infections. ( 5.7 ) Transmission of rare genetic diseases: Monitor patients for rare genetic diseases. ( 5.8 ) 5.1 Graft-versus-Host Disease Acute and chronic graft-versus-host disease (GvHD) have occurred following treatment with OMISIRGE [see Adverse Reactions (6.1) ] . Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. 4 CONTRAINDICATIONS OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products. Known sensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material. ( 4 )