Allergic reactions may occur with infusion of hematopoietic progenitor cells, cord blood (HPC-C), including HEMACORD. Reactions include bronchospasm, wheezing, angioedema, pruritus and hives [see Adverse Reactions (6)]. Serious hypersensitivity reactions, including anaphylaxis, also have been reported. These reactions may be due to dimethyl sulfoxide (DMSO), Dextran 40, or a plasma component of HEMACORD.
5.2 Infusion Reactions
Infusion reactions are expected to occur and include nausea, vomiting, fever, rigors or chills, flushing, dyspnea, hypoxemia, chest tightness, hypertension, tachycardia, bradycardia, dysgeusia, hematuria, and mild headache. Premedication with antipyretic, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions.
Severe reactions, including respiratory distress, severe bronchospasm, severe bradycardia with heart block or other arrhythmias, cardiac arrest, hypotension, hemolysis, elevated liver enzymes, renal compromise, encephalopathy, loss of consciousness, and seizure also may occur. Many of these reactions are related to the amount of DMSO administered. Minimizing the amount of DMSO administered may reduce the risk of such reactions, although idiosyncratic responses may occur even at DMSO doses thought to be tolerated. The actual amount of DMSO depends on the method of preparation of the product for infusion. Limiting the amount of DMSO infused to no more than 1 gm/kg/day is recommended. [See Overdosage (10)]
If infusing more than one unit of HPC-C on the same day, do not administer subsequent units until all signs and symptoms of infusion reactions from the prior unit have resolved.
Infusion reactions may begin within minutes of the start of infusion of HEMACORD, although symptoms may continue to intensify and not peak for several hours after completion of the infusion. Monitor the patient closely during this period. When a reaction occurs, discontinue the infusion and institute supportive care as needed.
5.3 Graft-versus-Host Disease (GVHD)
Acute and chronic GVHD may occur in patients who have received HEMACORD. Classic acute GVHD is manifested as fever, rash, elevated bilirubin and liver enzymes, and diarrhea. Patients transplanted with HEMACORD also should receive immunosuppressive drugs to decrease the risk of GVHD. [See Adverse Reactions (6.1)]
5.4 Engraftment Syndrome
Engraftment syndrome is manifested as unexplained fever and rash in the peri-engraftment period. Patients with engraftment syndrome also may have unexplained weight gain, hypoxemia, and pulmonary infiltrates in the absence of fluid overload or cardiac disease. If untreated, engraftment syndrome may progress to multiorgan failure and death. Begin treatment with corticosteroids once engraftment syndrome is recognized in order to ameliorate the symptoms. [See Adverse Reactions (6.1)]
5.5 Graft Failure
Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500/uL blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Patients should be monitored for laboratory evidence of hematopoietic recovery. Consider testing for HLA antibodies in order to identify patients who are alloimmunized prior to transplantation and to assist with choosing a unit with a suitable HLA type for the individual patient. [See Adverse Reactions (6.1)]
5.6 Malignancies of Donor O |
