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Hemacord
  • Professionals
  • FDA PI

Hemacord

Generic name: human cord blood hematopoietic progenitor cell
Dosage form: injection

WARNING: FATAL INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE,
ENGRAFTMENT SYNDROME AND GRAFT FAILURE

Fatal infusion reactions: Hemacord administration can result in serious, including fatal, infusion reactions. Monitor patients and discontinue Hemacord infusion for severe reactions. [See Warnings and Precautions ( 5.1, 5.2)]

Graft-vs-host disease (GVHD): GVHD is expected after administration of Hemacord, and may be fatal. Administration of immunosuppressive therapy may decrease the risk of GVHD. [See Warnings and Precautions ( 5.3)]

Engraftment syndrome: Engraftment syndrome may progress to multiorgan failure and death. Treat engraftment syndrome promptly with corticosteroids. [See Warnings and Precautions ( 5.4)]

Graft failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery. Prior to choosing a specific unit of Hemacord, consider testing for HLA antibodies to identify patients who are alloimmunized. [See Warnings and Precautions ( 5.5)]

Indications and Usage for Hemacord

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 manife..