DUCORD- human cord blood hematopoietic progenitor cell solution

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:

Duke University School of Medicine, Carolinas Cord Blood Bank

INN (International Name):

human cord blood hematopoietic progenitor cell

Composition:

human cord blood hematopoietic progenitor cell 900000000 in 25 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

DUCORD, 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. Risk Summary There are no data with DUCORD use in pregnant women to inform a product-associated risk. Animal reproduction studies have not been conducted with DUCORD. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in

Product summary:

DUCORD is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 9 × 108 total nucleated cells with a minimum of 1.25 × 106 viable CD34+ cells in a volume of 25 milliliters (ISBT 128, Product Code S1333000, ISBT 128 Facility Identifier Number W1582). The exact pre-cryopreservation nucleated cell content is provided on the container label and accompanying records. DUCORD units manufactured prior to 01-06-2014 are supplied in a cryopreservation bag with up to 3 attached segments and spike ports that are compatible with the Pall Cell wash/infusion bag set (see section I in Instructions for Preparation for Infusion below). DUCORD units manufactured on and after 01-06-2014 are supplied in the Biosafe 4b bag, which contains up to 4 attached segments and slightly modified spike ports. The 4b bag must be spiked with the Biosafe 4b coupler, which can be heat-sealed to the Pall Cell wash/infusion bag set (see section II,3 in Instructions for Preparation for Infusion below). The year of manufacture is noted in the ISBT number (W1582 14 …, for manufacture in 2014), and the specific date of manufacture can be found on page 3 of the NMDP CBU Detail Report. Store DUCORD at or below -150 ° C until ready for thawing and preparation.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

DUCORD- HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL SOLUTION
DUKE UNIVERSITY SCHOOL OF MEDICINE, CAROLINAS CORD BLOOD BANK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DUCORD SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DUCORD.
DUCORD (HPC, CORD BLOOD)
INJECTABLE SUSPENSION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2012
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
Box Warning
01/2015
Contraindications (4)
11/2015
INDICATIONS AND USAGE
DUCORD, HPC (Hematopoietic Progenitor Cell), 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 DUCORD should be done under the
direction of