Hematopoietic Progenitor Cells, Cord Blood

Hematopoietic Progenitor Cells, Cord Blood is an allogeneic cord blood hematopoietic progenitor cell (HPC-C) therapy 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 are available under the following different brand names: HemaCord.

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

Serious side effects of Hematopoietic Progenitor Cells, Cord Blood 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

Rare side effects of Hematopoietic Progenitor Cells, Cord Blood include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

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 provided on container label and accompanying records

Stem cell transplantation

Adult and pediatric dosage

• 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's characteristics, including disease, stage, risk factors, and specific manifestations of the disease, on characteristics of the graft, and other available treatments or types of hematopoietic progenitor cells
• Dose & human leukocyte antigens (HLA) matching
• Recommended minimum 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 is recommended
• HLA typing and nucleated cell content for each HPC-C unit are documented on the container label and/or in accompanying records

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, 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, healthcare provider, or pharmacist first.

• Hematopoietic Progenitor Cells, Cord Blood has no noted severe interactions with any other drugs
• Hematopoietic Progenitor Cells, Cord Blood has no noted serious interactions with any other drugs
• Hematopoietic Progenitor Cells, Cord Blood has no noted moderate interactions with any other drugs
• Hematopoietic Progenitor Cells, Cord Blood has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

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

Effects of drug abuse

• None

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?”

Cautions

• 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 hemoglobins 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; pre-medicate 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 above 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 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 with caution if the benefits outweigh the risks during pregnancy
• Lactation
  • Unknown whether distributed in breast milk; caution advised