Hematopoietic Progenitor Cells, Cord Blood

Hematopoietic progenitor cells, cord blood is used for unrelated donor hematopoietic progenitor stem cell transplantation procedures in disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

Hematopoietic progenitor cells, cord blood is available under the following different brand names: HemaCord.

Dosage Forms and Strengths

Cryopreserved Cell Suspension

• Contains a minimum of 5 x 10^8 total nucleated cells with a minimum of 1.25 x 10^6 viable CD34+ cells per 25 mL
• Suspended in 10% dimethyl sulfoxide (DMSO) and 1% Dextran 40, at the time of cryopreservation
• Exact pre-cryopreservation nucleated cell content is provided on the container label and accompanying records

Dosage Considerations – Should be Given as Follows:

Stem Cell Transplantation

• Allogeneic cord blood hematopoietic progenitor cell (HPC-C) therapy indicated for unrelated donor hematopoietic progenitor stem cell transplantation procedures in disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
• Use in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution
• The risk-benefit assessment for an individual patient depends on the patient characteristics, including disease, stage, risk factors, and specific manifestations of the disease, characteristics of the graft, and other available treatments or types of hematopoietic progenitor cells

Dose and HLA matching

• Recommended minimum intravenous (IV) dose: 2.5 x 10^7 nucleated cells/kg at cryopreservation; multiple units may be required to achieve the appropriate dose
• Matching for at least 4 of 6 HLA-A antigens, HLA-B antigens, and HLA-DRB1 alleles are recommended
• HLA typing and nucleated cell content for each HPC-C unit are documented on the container label and/or in accompanying records

Renal Impairment

• Contains Dextran 40 which is eliminated by the kidneys
• Safety of HPC-C has not been established in patients with renal insufficiency or renal failure

Administration

• For IV use only
• Do not irradiate
• Adults: Begin IV infusion at 100 mL/hour and increase the rate as tolerated
• Decrease infusion rate if the fluid load is not tolerated
• Discontinue the infusion if an allergic reaction occurs, or if a moderate-to-severe infusion reaction develops
• Monitor for adverse reactions during and for at least 6 hours after administration
• Because HPC-C contains lysed red cells that may cause renal failure, careful monitoring of urine output is also recommended

Common side effects of hematopoietic progenitor cells, cord blood include:

• High blood pressure (hypertension)
• Acute graft-versus-host disease (GVHD)
• Day-100 mortality from all causes
• Infusion reaction
• Engraftment syndrome
• Primary graft failure
• Vomiting
• Nausea
• Sinus bradycardia
• Allergy
• Low blood pressure (hypotension)
• Hemoglobinuria
• Hypoxia

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Hematopoietic progenitor cells, cord blood has no listed severe interactions with other drugs.
• Hematopoietic progenitor cells, cord blood has no listed serious interactions with other drugs.
• Hematopoietic progenitor cells, cord blood has no listed moderate interactions with other drugs.
• Hematopoietic progenitor cells, cord blood has no listed mild interactions with other drugs.
   

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings
 

This medication contains hematopoietic progenitor cells, cord blood. Do not take HemaCord if you are allergic to hematopoietic progenitor cells, cord blood or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Black Box Warnings

Fatal infusion reactions

• Administration can result in serious, including fatal, infusion reactions
• Monitor patients and discontinue infusion for severe reactions
• Contraindicated with known allergy to dimethyl sulfoxide (DMSO), Dextran 40 or human serum albumin

Graft vs host disease (GVHD)

• GVHD is expected after administration and may be fatal
• Administration of immunosuppressive therapy may decrease the risk of GVHD

Engraftment syndrome

• Engraftment syndrome may progress to multiorgan failure and death
• Treat promptly with corticosteroids

Graft failure

• Graft failure may be fatal
• Monitor for laboratory evidence of hematopoietic recovery
• Before choosing a specific unit of HPC-C, consider testing for HLA antibodies to identify patients who are also immunized

Contraindications

• Known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40 or plasma proteins

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Hematopoietic Progenitor Cells, Cord Blood?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Hematopoietic Progenitor Cells, Cord Blood?”

• Acute and chronic GVHD may occur; patients should also receive immunosuppressive drugs to decrease the risk of GVHD
• Engraftment syndrome is manifested as unexplained fever and rash in the peri-engraftment period; may also have unexplained weight gain, hypoxemia, and pulmonary infiltrates in the absence of fluid overload or cardiac disease
• Primary graft failure, which may be fatal, may occur; defined as failure to achieve an absolute neutrophil count greater than 500/uL blood by Day 42 after transplantation
• Allergic reactions may occur and include bronchospasm, wheezing, angioedema, pruritus and hive; serious hypersensitivity reactions, including anaphylaxis, also have been reported and may be due to DMSO, Dextran 40, or a plasma component

Malignancy of donor origin

• Patients who have undergone HPC-C transplantation may develop the post-transplant lymphoproliferative disorder (PTLD) manifested as a lymphoma-like disease favoring non-nodal sites
• PTLD is usually fatal if not treated
• PTLD incidence appears to be higher in patients who have received antithymocyte globulin. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV)

Transmission of serious infection

• May occur because HPC-C is derived from human blood
• Donors are screened for increased risk of infection 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 vaccine
• Donors are also screened for clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation
• Maternal blood samples are tested for HIV types 1 and 2, HTLV types I and II, HBV, HCV, T. pallidum, WNV, and T. cruzi
• Testing is also performed for evidence of donor infection due to CMV; however, this is not a donor selection criterion

Transmission of rare genetic diseases

• May transmit rare genetic diseases involving the hematopoietic system for which donor screening and/or testing has not been performed
• Cord blood donors have been screened by family history to exclude inherited disorders of the blood and marrow
• HPC-C has been tested to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobin C, D, and E
• Because of the age of the donor at the time HPC-C collection takes place, the ability to exclude rare genetic diseases is severely limited

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; premedicate with antipyretic, histamine antagonists and corticosteroids to decrease incidence/intensity of infusion reactions
• Severe reactions may also occur and include 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
• Many of these reactions are related to the amount of DMSO administered; do not exceed 1 g/kg/day of DMSO; the actual amount of DMSO depends on the method of preparation of the product for infusion
• If infusing more than 1 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 been resolved
• Infusion reactions may begin within minutes of the start of the infusion, although symptoms may continue to intensify and not peak for several hours after completion of the infusion; monitor closely during this period
• When a reaction occurs, discontinue the infusion and institute supportive care as needed

Pregnancy and Lactation

Use hematopoietic progenitor cells, cord blood with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.

It is unknown whether hematopoietic progenitor cells, cord blood is distributed in breast milk. Caution is advised while breastfeeding.