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Omisirge Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Metal cassettes (CF bag + NF bag)—2 + Container (Infusion soln bags)—2
Manufacturer
Generic Availability
NO
Mechanism of Action
Omisirge is derived from cord blood used as an allogeneic stem cell donor source. Omisirge is manufactured utilizing a proprietary nicotinamide (NAM) based technology producing enriched hematopoietic progenitor cells (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.
Omisirge Indications
Indications
In patients 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.
Omisirge Dosage and Administration
Adults and Children
<12yrs: not established. For IV use only. Do not use a leukodepleting filter. Verify patient's identity. Premedicate with diphenhydramine IV (or dexchlorpheniramine IV), hydrocortisone IV, and APAP orally ~30–60mins prior to Omisirge infusion. ≥12yrs: Infuse CF bag first within 2hrs (max 2hrs infusion time from the end of dilution to the end of CF infusion), then infuse NF bag within 1hr (max 1hr infusion time from the end of dilution to the end of NF infusion). Rate of infusion: max 10mL/kg/hr. Preparation, administration, and others: see full labeling.
Omisirge Contraindications
Contraindications
Hypersensitivity to dimethyl sulfoxide (DMSO), dextran 40, gentamicin, human serum albumin, or bovine products.
Omisirge Boxed Warnings
Boxed Warning
Infusion reactions. Graft-versus-host disease (GVHD). Engraftment syndrome. Graft failure.
Omisirge Warnings/Precautions
Warnings/Precautions
Should be administered under the supervision of an experienced physician. Monitor for hypersensitivity reactions in those with a history of allergic reactions to antibiotics. Monitor for infusion reactions during and after administration; discontinue if severe reactions occur. Monitor for GVHD; treat if develops. Engraftment syndrome; treat promptly with corticosteroids. Primary graft failure. Monitor for lab evidence of hematopoietic recovery, closely for serious infections, rare genetic diseases, and lifelong for secondary malignancies. Ensure adequate hydration. Elderly. Pregnancy: exclude status prior to initiation (including sexually-active females of reproductive potential prior to the conditioning regimen). Nursing mothers.
Omisirge Pharmacokinetics
See Literature
Omisirge Interactions
Not Applicable
Omisirge Adverse Reactions
Adverse Reactions
Infections, GVHD, infusion reactions; hypersensitivity reactions.
Omisirge Clinical Trials
See Literature
Omisirge Note
Not Applicable
Omisirge Patient Counseling
See Literature
