hematopoietic progenitor cells, human cord blood

General

Pronunciation:
hee-mat-oh-poe-et-ik proe-jen-i-ter sels, hyoo-man kord blud


Trade Name(s)

  • Allocord
  • HPC, Cord Blood

Ther. Class.

none assigned

Pharm. Class.

blood products

Indications

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.

Action

  • Following intravenous administration HPC, Cord Blood, migrate to bone marrow where division and maturation follows. Functional cells are then released into circulation or migrate to sites of action.
  • Derived from human umbililcal cord blood and placenta

Therapeutic Effect(s):

Restoration of blood counts and function including immunologic activity.

Pharmacokinetics

Absorption: IV administration results in complete bioavialability.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: Unknown.

TIME/ACTION PROFILE (hematopoietic recovery times)

ROUTEneutrophilsplateletserythrocytes
IV25–27 days90–113 days64 days

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity;
  • Known allergy to dimethyl sulfoxide (DMSO), human serum albumin or dextran 40.

Use Cautiously in:

  • Renal impairment (safe use had not been established);
  • Geri:  Consider age-related decrease in cardiac, renal or hepatic function, concurrent disease states and drug therapy;
  • OB:  Use during pregnancy only if potential benefit justifies potential risk to the fetus.

Adverse Reactions/Side Effects

CV: bradycardia, hypertension, tachycardia

GI: nausea, vomiting

GU: hemoglobinuria

Resp: hypoxia

Misc: fever, allergic reactions including anaphylaxis, ENGRAFTMENT SYNDROME, GRAFT FAILURE, GRAFT VERSUS HOST DISEASE, INFUSION REACTIONS, LEUKEMIA, POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER (PTLD), transmission of infectious diseases, transmission of rare genetic diseases

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

None noted

Route/Dosage

IV (Adults and Children): Minimum dose: 2.5 x 107  nucleated cells/kg at cyropreservation (limit DMSO administration to 1 G/kg body weight/day).

Availability

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

Assessment

  • 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.

Implementation

  • Should be prepared by a trained health care professional and administered under supervision of a qualified health care professional.
  • Do not irradiate.
  • Limit DMSO administration to 1 G/kg body weight/day.
  • Emergency medications must be readily available during administration.
  • Patient should be well hydrated prior to administration.
  • Premedicate prior to administration with antipyretics, histamine antagonists, and corticosteroids.

IV Administration

  • 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.

Patient/Family Teaching

  • Inform patient of purpose of hematopoetic progenitor cells.
  • Advise patient to notify health care professional immediately if signs and symptoms of infusion reactions or graft-versus-host disease (rash, diarrhea, yellow eyes) occur.
  • Instruct female patient to notify health care professional if pregnancy is suspected.

Evaluation/Desired Outcomes

Absolute neutrophil count ≥500 microliter blood by Day 42 after transplantation.