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 (hematopoietic progenitor cells, cord blood)
Injectable Suspension for Intravenous Use
Initial U.S. Approval: November 10, 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. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40 or human serum albumin. (4, 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)
INDICATIONS AND USAGE
HEMACORD 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
•Unit selection and administration of HEMACORD should be done under the direction of a physician experienced in hematopoietic progenitor cell transplantation
•The recommended minimum dose is 2.5 x 107 nucleated cells/kg at cryopreservation. (2.1)
•Do not administer HEMACORD through the same tubing with other products except for normal saline. (2.3)
DOSAGE FORMS AND STRENGTHS
Each unit contains a minimum of 5 x 108 total nucleated cells with at least 1.25 x 106 viable CD34+ cells at the time of cryopreservation. The exact pre-cryopreservation nucleated cell content of each unit is provided on the container label and accompanying records. (3)
CONTRAINDICATIONS
Known sensitivity to dimethyl sulfoxide (DMSO), Dextran 40 or plasma proteins. (4)
WARNINGS AND PRECAUTIONS
•Allergic Reactions and Anaphylaxis (5.1)
•Infusion Reactions (5.2)
•Graft-versus-Host Disease (5.3)
•Engraftment Syndrome (5.4)
•Graft Failure (5.5)
•Malignancies of Donor Origin (5.6)
•Transmission of Serious Infections (5.7)
•Transmission of Rare Genetic Diseases (5.8)
ADVERSE REACTIONS
Mortality, from all causes, at 100 days post-transplant was 25%. (5, 6.1)
The most common infusion-related adverse reactions (≥5%) are hypertension, vomiting, nausea, bradycardia, and fever. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact the New York Blood Center at 1-866-767-NCBP (1-866-767-6227) and FDA at 1-800-FDA-1088 or www.fda.gov/m