Adjunctive treatment (with a preparative regimen which includes immunosuppressives) in patients undergoing unrelated donor hematopoietic progenitor stem cell transplantation as part of hematopoietic and immunologic reconstitution; as part of a regimen in patients with hematopoietic system disorders that are inherited, acquired or due to myeloablative treatment.
Suspension for intravenous use (contains 10% DMSO, human serum albumin and 1% Dextran 40 ): 5 x 108 total nucleated cells with at least 1.25 x 108 viable CD34+ cells at the time of cryopreservation per unit
Monitor for hypersensitivity reactions (bronchospasm, wheezing, angioedema, pruritus, hives, anaphylaxsis) during and following infusion. May be due to DMSO, Dextran 40, or a plasma component. Premedicate prior to infusion and treat as needed.
Monitor for infusion reactions. Expected reactions include nausea, vomiting, fever, rigors, chills, flushing, dyspnea, hypoxemia, chest tightness, hypertension, tachycardia, bradycardia, dysgeusia, hematuria, and mild headache. Premedicate with antipyretics, histamine antigonists, and corticosteroids. If severe reaction (respiratory distress, severe bronchospasm, severe bradycardia with heart block or other arrhythmias, cardiac arrest, hypotension, hemolysis, elevated liver enzymes, renal dysfunction, encephalopathy, loss of consciousness, seizure) occurs, may be due to amount of DSMO. May begin within minutes of start of infusion and may intensify and not peak for several hours after completion. Discontinue infusion if a reaction occurs.
Monitor for signs and symptoms of acute and chronic graft-versus-host disease (GVHD) (fever, rash, elevated bilirubin and liver enzymes, diarrhea). Administer immunosuppressive drugs to decrease risk of GVHD.
Monitor for signs and symptoms of engraftment syndrome (fever, rash during peri-engraftment period, unexplained weight gain, hypoxemia, pulmonary infiltrates in the absence of fluid overload or cardiac disease). May progress to multiorgan failure and death if untreated. Treat with corticosteroids.
Lab Test Considerations:
Monitor absolute neutrophil count for evidence graft failure, failure to achieve absolute neutrophil count >500 microliter blood by Day 42 after transplantation. Primary cause is immunologic rejection. May test for HLA antibodies prior to transplantation for a suitable type.
Monitor blood for Epstein-Barr virus DNA in patients high-risk for post-transplant lymphoproliferative disorder. Patients who have received antithymocyte globulin may be at greater risk.
Intermittent Infusion: Do not administer in same tubing as medications or fluids other than 0.9% NaCl. May filter through a 170–260 micron filter designed to remove clots. Do not use filter designed to remove leukocytes. May be stored at 4–25° C for up to 4 hr.
For multiple units, infuse each unit independently; if a reaction occurs, manage prior to thawing next unit.
Rate: Adults – 100 mL/hr, increase rate as tolerated. Children – 1 mL/kg/hr, increase rate as tolerated. If fluid load is not tolerated, reduce infusion rate. Discontinue infusion if allergic reaction or moderate to severe infusion reaction occurs.