HEMACORD- human cord blood hematopoietic progenitor cell injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL (UNII: XU53VK93MC) (HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL - UNII:XU53VK93MC)

Available from:

New York Blood Center

INN (International Name):

HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL

Composition:

HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL 500000000 in 25 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

HEMACORD, HPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from 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. None Pregnancy Category C. Animal reproduction studies have not been conducted with HEMACORD. It is also not known whether HEMACORD can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no adequate and well-controlled st

Product summary:

HEMACORD is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 5 x 10 8 total nucleated cells with a minimum of 1.25 x 10 6 viable CD34+ cells in a volume of 25 milliliters (NDC# 76489-001-01). The exact pre-cryopreservation nucleated cell content is provided on the container label and accompanying records. Store HEMACORD at or below -150 °C until ready for thawing and preparation.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

HEMACORD- HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL INJECTION
NEW YORK BLOOD CENTER
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEMACORD SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HEMACORD.
HEMACORD (HPC, CORD BLOOD)
INJECTABLE SUSPENSION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2011
WARNING: FATAL INFUSION REACTIONS, GRAFT VERSUS
HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT
FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FATAL INFUSION REACTIONS: MONITOR PATIENTS DURING INFUSION AND
DISCONTINUE FOR SEVERE
REACTIONS. ( 5.1, 5.2)
GRAFT-VS-HOST DISEASE (GVHD): GVHD MAY BE FATAL. ADMINISTRATION OF
IMMUNOSUPPRESSIVE THERAPY MAY DECREASE THE RISK OF GVHD ( 5.3)
ENGRAFTMENT SYNDROME: ENGRAFTMENT SYNDROME MAY BE FATAL. TREAT
ENGRAFTMENT
SYNDROME PROMPTLY WITH CORTICOSTEROIDS ( 5.4)
GRAFT FAILURE: GRAFT FAILURE MAY BE FATAL. MONITOR PATIENTS FOR
LABORATORY EVIDENCE OF
HEMATOPOIETIC RECOVERY ( 5.5)
RECENT MAJOR CHANGES
Boxed Warning 5/2015
Contraindications ( 4.0) 5/2015
INDICATIONS AND USAGE
HEMACORD HPC, Cord Blood, is an allogeneic cord blood hematopoietic
progenitor cell therapy indicated
for use in unrelated donor hematopoietic progenitor cell
transplantation procedures in conjunction with an
appropriate preparative regimen for hematopoietic and immunologic
reconstitution in patients with
disorders affecting the hematopoietic system that are inherited,
acquired, or result from myeloablative
treatment ( 1)
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 ( 1)
DOSAGE AND ADMINISTRATION
For intravenous use only
Do not irradiate
Unit selection and administration of HEMACORD should be done under the
direction of a physician
experienced in hematopoietic progenitor cell t