HemaCord

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/3/2021
HemaCord Side Effects Center

What Is HemaCord?

HemaCord (human cord blood hematopoietic progenitor cell injection) 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.

What Are Side Effects of HemaCord?

Side effects of HemaCord include:

Dosage for HemaCord

The recommended minimum dose of HemaCord is 2.5 X 107 nucleated cells/kg at cryopreservation.

HemaCord In Children

Hematopoietic progenitor cell (HPC), cord blood, has been used in pediatric patients with disorders affecting the hematopoietic system that are inherited, acquired, or resulted from myeloablative treatment.

What Drugs, Substances, or Supplements Interact with HemaCord?

HemaCord may interact with other medicines.

Tell your doctor all medications and supplements you use.

HemaCord During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using HemaCord; it is unknown how it might affect a fetus.  Consult your doctor before breastfeeding. 

Additional Information

Our HemaCord (human cord blood hematopoietic progenitor cell injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. 

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
HemaCord Professional Information

SIDE EFFECTS

Day-100 mortality from all causes was 25%.

The most common infusion-related adverse reactions (≥ 5%) are hypertension, vomiting, nausea, bradycardia, and fever.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Infusion Reactions

The data described in Table 1 reflect exposure to 442 infusions of HPC, Cord Blood, (from multiple cord blood banks) in patients treated using a total nucleated cell dose ≥2.5 x 107/kg on a single-arm trial or expanded access use (The COBLT Study). The population was 60% male and the median age was 5 years (range 0.05-68 years), and included patients treated for hematologic malignancies, inherited metabolic disorders, primary immunodeficiencies, and bone marrow failure. Preparative regimens and graft-vs.-host disease prophylaxis were not standardized. The most common infusion reactions were hypertension, vomiting, nausea, and sinus bradycardia. Hypertension and any grades 3-4 infusion related reactions occurred more frequently in patients receiving HPC, Cord Blood, in volumes greater than 150 milliliters and in pediatric patients. The rate of serious adverse cardiopulmonary reactions was 0.8%.

Table 1: Incidence of Infusion-Related Adverse Reactions Occurring in ≥ 1% of Infusions (The COBLT Study)

Any grade Grade 3-4
Any reaction 65.4% 27.6%
Hypertension 48.0% 21.3%
Vomiting 14.5% 0.2%
Nausea 12.7% 5.7%
Sinus bradycardia 10.4% 0
Fever 5.2% 0.2%
Sinus tachycardia 4.5% 0.2%
Allergy 3.4% 0.2%
Hypotension 2.5% 0
Hemoglobinuria 2.1% 0
Hypoxia 2.0% 2.0%

Information on infusion reactions was available from voluntary reports for 244 patients who received HEMACORD. The population included 56% males and 44% females with median age of 25 years (range 0.2-73 years). Preparative regimens and graft-vs.-host disease prophylaxis were not standardized. The reactions were not graded. An infusion reaction occurred in 18% of patients. The most common infusion reactions, occurring in ≥ 1% of patients, were hypertension (14%), nausea (5%), vomiting (4%), hypoxemia (3%), dyspnea (1%), tachycardia (1%), and cough (1%). The rate of serious adverse cardiopulmonary reactions was 0.1%.

Other Adverse Reactions

For other adverse reactions, the raw clinical data from the docket were pooled for 1299 (120 adult and 1179 pediatric) patients transplanted with HPC, Cord Blood, (from multiple cord blood banks) with total nucleated cell dose ≥ 2.5 x 107/kg. Of these, 66% (n=862) underwent transplantation as treatment for hematologic malignancy. The preparative regimens and graft-vs.-host disease prophylaxis varied. The median total nucleated cell dose was 6.47 x 10 /kg (range, 2.5-73.8 x 107/kg). For these patients, Day-100 mortality from all causes was 25%. Primary graft failure occurred in 16%; 42% developed grades 2-4 acute graft-vs.-host disease; and 19% developed grades 3-4 acute graft-vs.-host disease.

Data from published literature and from observational registries, institutional databases, and cord blood bank reviews reported to the docket for HPC, Cord Blood, (from multiple cord blood banks) revealed nine cases of donor cell leukemia, one case of transmission of infection, and one report of transplantation from a donor with an inheritable genetic disorder. The data are not sufficient to support reliable estimates of the incidences of these events.

In a study of 364 patients, 15% of the patients developed engraftment syndrome.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for HemaCord (HPC, Cord Blood)

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© HemaCord Patient Information is supplied by Cerner Multum, Inc. and HemaCord Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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