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General Information
Omisirge is supplied as a suspension for intravenous administration.
A single dose of Omisirge consists of two separate bags:
Cultured Fraction (CF): a minimum of 8.0 × 108 total viable cells of which a minimum of 8.7% is CD34+ cells and a minimum of 9.2 × 107 CD34+ cells
Non-cultured Fraction (NF): a minimum of 4.0 × 108 total viable cells with a minimum of 2.4 × 107 CD3+ cells.
Administration:
The patient’s identity must match the patient-specific identifiers on the CF and NF metal cassettes, the CF and NF bags, and the respective Infusion Solution for CF and NF bags. Do NOT infuse Omisirge if the information on the patient-specific labels does not match the intended patient.
Administer an appropriate conditioning regimen before infusion of Omisirge, according to institutional guidelines.
Administer prophylactic and supportive therapies for prevention or treatment of transplant complications (GvHD, infections) according to institutional guidelines. Confirm emergency medications are available prior to infusion and during the recovery period as per institutional guidelines.
Premedicate the patient approximately 30 to 60 minutes prior to infusion
The CF bag must be administered FIRST, and infusion should not exceed 2 hours from the end of dilution.
Infusion of the NF 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, in centers with expertise in hematopoietic stem cell transplants
Mechanism of Action
Omisirge (omidubicel-onlv) 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.
Side Effects
Adverse effects associated with the use of Omisirge may include, but are not limited to, the following:
- infections
- GvHD
- infusion reaction
The Omisirge drug label comes with the following Black Box warning: 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. Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD. Engraftment syndrome: Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroid. Graft failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.
Clinical Trial Results
The FDA approval of Omisirge was based on a global, randomized Phase 3 clinical study, Omisirge demonstrated a median time to neutrophil recovery of 12 days in the intent to treat population, compared to 22 days for standard cord blood. Incidence of Grade 2/3 bacterial or Grade 3 fungal infections through 100 days following transplantation occurred in 39% of patients in the Omisirge arm and 60% of patients in the standard cord blood arm.