Omidubicel

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. adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning.

OMISIRGE is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy derived from cord blood used as an allogeneic stem cell donor source. OMISIRGE is manufactured utilizing a proprietary NAM based technology producing enriched HPCs. NAM technology overcomes the induction of accelerated proliferation, differentiation, cellular stress and signaling pathways that are typically activated when HPCs are removed from their natural environment. Ex-vivo culturing of cord blood derived HPCs in the presence of NAM leads to preservation of their stemness, homing to the bone marrow (BM) and retained engraftment capacity as demonstrated by rapid neutrophil engraftment and multi lineage immune reconstitution as observed in the clinical trials with OMISIRGE.

For intravenous use only. Do not irradiate. Do not use a leukodepleting filter. Verify patient's identity upon receipt, prior to thaw and prior to infusion. Thawing should only take place immediately prior to use. Premedicate the patient approximately 30 to 60 minutes prior to infusion. The recommended dose of OMISIRGE is a one-time infusion delivered in two separate bags. The CF (Cultured Fraction) bag must be administered FIRST, and infusion should not exceed 2 hours from the end of dilution. Infusion of the NF (Non-cultured) bag should not exceed 1 hour from the end of dilution. Administration of OMISIRGE should be under the supervision of a physician experienced in treatment of hematologic malignancies or SAA, as appropriate, in centers with expertise in hematopoietic stem cell transplants. See full prescribing information for details for preparation and administration of OMISIRGE.

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.

Boxed warning: Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD. Infusion reactions: 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. 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. Transmission of serious infections: Monitor patients closely for serious infections. Transmission of rare genetic diseases: Monitor patients for rare genetic diseases.

Hematological malignancies: The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion and hypersensitivity reactions. 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.

Store the IS bags in a 2-8℃ refrigerated storage until the time of thaw of the OMISIRGE CF and NF.