hematopoietic progenitor cells, human cord blood

REMS

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.

Contraind./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.

Adv. 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

Interactions ⬆ ⬇

Drug-drug:

None noted

Availability ⬆ ⬇

Suspension for intravenous use (contains 10% DMSO, human serum albumin and 1% Dextran 40 ): 5 x 10⁸total nucleated cells with at least 1.25 x 10⁸viable CD34+ cells at the time of cryopreservation per unit

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).

US Brand Names ⬆ ⬇

Allocord, HPC, Cord Blood

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 effects:

Restoration of blood counts and function including immunologic activity.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: blood products

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavialability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(hematopoietic recovery times)

ROUTE	neutrophils	platelets	erythrocytes
IV	25–27 days	90–113 days	64 days

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.

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Indications ⬇