HEMACORD (HPC, Cord Blood)

Time 2020-11-05 01:05:34

Web Name: HEMACORD (HPC, Cord Blood)

WebSite: http://hemacord.info

ID:105236

Keywords:

HPC,HEMACORD,Blood,

Description:

We are pleased to announce the availability of HEMACORD (HPC, Cord Blood), the first FDA approved allogeneic cord-blood derived hematopoietic stem cell therapy product There are thousands of HEMACORD (HPC, Cord Blood) units available in inventory to provide the best possible matches. Indications and UsageFor use in unrelated donor hematopoietic progenitor cell transplantationprocedures in conjunction with an appropriate preparative regimen forhematopoietic and immunologic reconstitution in patients with disordersaffecting the hematopoietic system that are inherited, acquired, or resultfrom myeloablative treatment.The risk benefit assessment for an individual patient depends on the patient characteristics, including disease, stage, risk factors, and specific manifestations of the disease, on characteristics of the graft, and on other available treatments or types of hematopoietic progenitor cells.ContraindicationsHEMACORD (HPC, Cord Blood) is contraindicated in patients with known hypersensitivityto dimethyl sulfoxide (DMSO), Dextran 40 or plasma proteins. Important Safety InformationWarnings and PrecautionsHypersensitivity ReactionsAllergic reactions may occur with infusion of HPC, Cord Blood, including HEMACORD (HPC, Cord Blood). Reactions include bronchospasm, wheezing,angioedema, pruritus and hives [see Adverse Reactions]. 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 (HPC, Cord Blood).HEMACORD (HPC, Cord Blood) may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following HEMACORD (HPC, Cord Blood) administration.Infusion ReactionsInfusion reactions are expected to occur and include nausea, vomiting,fever, rigors or chills, flushing, dyspnea, hypoxemia, chest tightness,hypertension, tachycardia, bradycardia, dysgeusia, hematuria, and mildheadache. Premedication with antipyretic, histamine antagonists, andcorticosteroids may reduce the incidence and intensity of infusionreactions.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 ofthese reactions are related to the amount of DMSO administered. Minimizingthe amount of DMSO administered may reduce the risk of such reactions,although idiosyncratic responses may occur even at DMSO doses thought to betolerated. The actual amount of DMSO depends on the method of preparationof the product for infusion. Limiting the amount of DMSO infused to no morethan 1 gm/kg/day is recommended. If infusing more than one unit of HPC,Cord Blood on the same day, do not administer subsequent units until allsigns and symptoms of infusion reactions from the prior unit haveresolved.Infusion reactions may begin within minutes of the start of infusion ofHEMACORD (HPC, Cord Blood), although symptoms may continue to intensify and not peak forseveral hours after completion of the infusion. Monitor the patient closelyduring this period. When a reaction occurs, discontinue the infusion andinstitute supportive care as needed.Graft-versus-Host DiseaseAcute and chronic graft-versus-host disease (GVHD) may occur in patientswho have received HEMACORD (HPC, Cord Blood) Classic acute GVHD is manifested as fever,rash, elevated bilirubin and liver enzymes, and diarrhea. Patientstransplanted with HEMACORD (HPC, Cord Blood) also should receive immunosuppressive drugs todecrease the risk of GVHD.Engraftment SyndromeEngraftment syndrome is manifested as unexplained fever and rash in theperi-engraftment period. Patients with engraftment syndrome also may haveunexplained weight gain, hypoxemia, and pulmonary infiltrates in theabsence of fluid overload or cardiac disease. If untreated, engraftmentsyndrome may progress to multiorgan failure and death. Begin treatment withcorticosteroids once engraftment syndrome is recognized in order toameliorate the symptoms.Graft FailurePrimary graft failure, which may be fatal, is defined as failure toachieve an absolute neutrophil count greater than 500/uL blood by Day 42after transplantation. Immunologic rejection is the primary cause of graftfailure. Patients should be monitored for laboratory evidence ofhematopoietic recovery. Consider testing for HLA antibodies in order toidentify patients who are alloimmunized prior to transplantation and toassist with choosing a unit with a suitable HLA type for the individualpatient.Malignancies of Donor OriginPatients who have undergone HPC, Cord Blood transplantation may developpost-transplant lymphoproliferative disorder (PTLD), manifested as alymphoma-like disease favoring non nodal sites. PTLD is usually fatal ifnot treated. The incidence of PTLD appears to be higher in patients whohave received antithymocyte globulin. The etiology is thought to be donorlymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoringof blood for EBV DNA may be warranted in high-risk groups. Leukemia ofdonor origin also has been reported in HPC, Cord Blood recipients. Thenatural history is presumed to be the same as that for de novoleukemia.Transmission of Serious InfectionsTransmission of infectious disease may occur because HEMACORD (HPC, Cord Blood) isderived from human blood. Disease may be caused by known or unknowninfectious agents. Donors are screened for increased risk of infection withhuman immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV),hepatitis B virus (HBV), hepatitis C virus (HCV), T. pallidum, T. cruzi,West Nile Virus (WNV), transmissible spongiform encephalopathy (TSE)agents, and vaccinia. Donors are also screened for clinical evidence ofsepsis, and communicable disease risks associated with xenotransplantation.Maternal blood samples are tested for HIV types 1 and 2, HTLV types I andII, HBV, HCV, T. pallidum, WNV, and T. cruzi. These measures do not totallyeliminate the risk of transmitting these or other transmissible infectiousdiseases and disease agents. Report the occurrence of a transmittedinfection to the New York Blood Center at 1-866-767-NCBP(1-866-767-6227).Testing is also performed for evidence of donor infection due tocytomegalovirus (CMV); however, this is not a donor selection criterion.The result may be found on the container label and/or in accompanyingrecords.Transmission of Rare Genetic DiseasesHEMACORD (HPC, Cord Blood) may transmit rare genetic diseases involving thehematopoietic system for which donor screening and/or testing has not beenperformed. Cord blood donors have been screened by family history toexclude inherited disorders of the blood and marrow. HEMACORD (HPC, Cord Blood) has beentested to exclude donors with sickle cell anemia, and anemias due toabnormalities in hemoglobins C, D, and E. Because of the age of the donorat the time HEMACORD (HPC, Cord Blood) collection takes place, the ability to exclude raregenetic diseases is severely limited.Adverse ReactionsDay-100 mortality from all causes was 25%. The most commoninfusion-related adverse reactions ( 5%) are hypertension, vomiting,nausea, bradycardia, and fever. WARNING: FATAL INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENTSYNDROME AND GRAFT FAILUREFatal infusion reactions: HEMACORD (HPC, Cord Blood) administrationcan result in serious, including fatal, infusion reactions. Monitorpatients and discontinue HEMACORD (HPC, Cord Blood) infusion for severe reactions. Use iscontraindicated in patients with known allergy to dimethyl sulfoxide(DMSO), Dextran 40 or human serum albuminGraft-vs-host disease (GVHD): GVHD is expectedafter administration of HEMACORD (HPC, Cord Blood), and may be fatal. Administration ofimmunosuppressive therapy may decrease the risk of GVHD.Engraftment syndrome: Engraftment syndrome mayprogress to multiorgan failure and death. Treat engraftment syndromepromptly with corticosteroidsGraft failure: Graft failure may be fatal. Monitorpatients for laboratory evidence of hematopoietic recovery. Prior tochoosing a specific unit of HEMACORD (HPC, Cord Blood), consider testing for HLAantibodies to identify patients who are alloimmunized.

TAGS:HPC HEMACORD Blood 

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