Medical Editor: John P. Cunha, DO, FACOEP
Allocord (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 trans plantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with dis orders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. Common side effects of Allocord include:
- high blood pressure (hypertension),
- slow heart rate,
- hypersensitivity reactions (bronchospasm, wheezing, skin swelling, itching, and hives),
- rigors or
- shortness of breath,
- chest pain,
- blood in the urine,
- low blood oxygen,
- fast heart rate,
- changes in taste, and
- mild headache
The recommended minimum dose of Allocord is 2.5 x 107 nucleated cells/kg at cryopreservation. Allocord may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Allocord; it is unknown how it would affect a fetus. Consult your doctor before breastfeeding.
Our Allocord (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.
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.
The safety assessment of ALLOCORD is based primarily on review of the data submitted to the FDA dockets from various sources, the dataset for the COBLT Study, and published literature.
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 prospectivetrial or expanded access use (COBLT Study). The population was 59% 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 Infus ion-Related Adverse Reactions Occurring in ≥1% of Infusions (COBLT Study)
|Any grade||Grade 3-4|
Information on infusion reactions was available from voluntary reports for 737 patients who received ALLOCORD. Preparative regimens and graft-vs.-host disease prophylaxis were not standardized. The reactions were not graded. An infusion reaction occurred in 13% of patients. The most common infusion reactions, occurring in ≥ 1% of patients, were hypertension (54%), vomiting (12%), dyspnea (9%), bradycardia (6%), nausea (4%), chest pain (2%), hemoglobinuria (2%), fever (2%) and hives (2%).
Other Adverse Reactions
For other adverse reactions, the raw clinical data from the dockets 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 6.4 x 107/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 dockets 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 the COBLT Study, 15% of the patients developed engraftment syndrome.
Read the entire FDA prescribing information for Allocord (Cord Blood Injectable Suspension for Intravenous Use)