Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 24 May 2017

Indication(s)

CLEVECORD, 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)

 

Full Prescribing information

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Transplantation

Transplantation

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Fibrinogen Deficiency in Bleeding

Fibrinogen Deficiency in Bleeding

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Fluid Management

Fluid Management

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Advisory information

contraindications
None. (4)
Special warnings and precautions

WARNING: FATAL INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, ANDGRAFT 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-versus-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)




• Hypersensitivity Reactions (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)

Usage information

Dosing and administration
• For intravenous use only.
• Do not irradiate.

• Unit selection and administration of CLEVECORD should be done under the direction of a physician experienced in hematopoietic progenitor cell transplantation. (2)
• The recommended minimum dose is 2.5 x 107 nucleated cells/kg at cryopreservation. (2.1)
• Do not administer CLEVECORD through the same tubing with other products except for normal saline. (2.3)

More information

Category Value
Authorisation number BLA125594
Orphan designation No
Date First Approved 01-09-2016
Marketing authorisation holder Cleveland Cord Blood Center