Data Published in Transplantation and Cellular Therapy Suggest Antiviral Protection After Transplantation with Gamida Cell’s Omisirge (omidubicel-onlv) - Seite 2

Stem cell graft source is a known factor influencing immune reconstitution along with other factors such as patient age, disease type, preparative chemotherapy regimen and post-transplantation supportive care.^1,2 These data support past findings that Omisirge stimulates a faster immune response than standard cord blood.³

The authors noted several limitations to the study, including sample size. Additionally, there is limited available literature comparing immune reconstitution by donor source. Although age variation may influence immune reconstitution outcomes, an age-adjusted analysis found no age-specific effect.

Omisirge Indication

Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in 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 infection.

Important Safety Information for Omisirge

BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE

• Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.
• Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.
• Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.
• Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.

Contraindications

OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.

Warnings and Precautions

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.