c reconstitution, was demonstrated in one single-arm prospective study, and in retrospective reviews of data from an observational database for HEMACORD and data in the dockets and public information. Sixty-six percent (n=862) of the 1299 patients in the docket and public data underwent transplantation as treatment for hematologic malignancy. Results for patients who received a total nucleated cell dose ≥2.5 x 107/kg are shown in Table 2. Neutrophil recovery is defined as the time from transplantation to an absolute neutrophil count more than 500 per microliter. Platelet recovery is the time to a platelet count more than 20,000 per microliter. Erythrocyte recovery is the time to a reticulocyte count greater than 30,000 per microliter. The total nucleated cell dose and degree of HLA mismatch were inversely associated with the time to neutrophil recovery in the docket data.
Table 2. Hematopoietic Recovery for Patients Transplanted with HPC-C Total Nucleated Cell (TNC) Dose ≥ 2.5 x 107/kg Data Source The COBLT Study Docket and Public
Data HEMACORD
Design Single-arm prospective Retrospective Retrospective
Number of patients 324 1299 155
Median age (range) 4.6 (0.07 – 52.2) yrs 7.0 (<1 – 65.7) yrs 14.5 (0.2 – 72.6) yrs
Gender 59% male
41% female 57% male
43% female 54% male
46% female
Median TNC Dose
(range) (x 107/kg) 6.7 (2.6 – 38.8) 6.4 (2.5 – 73.8) 4.9 (2.5 – 39.8)
Neutrophil Recovery
at Day 42 76%
(95% CI 71% – 81%) 77%
(95% CI 75% – 79%) 83%
(95% CI 76% – 88%)
Platelet Recovery at
Day 100 (20,000/uL) 57%
(95% CI 51% – 63%) - 77%
(95% CI 69% – 84%)
Platelet Recovery at
Day 100 (50,000/uL) 46%
(95% CI 39% – 51%) 45%
(95% CI 42% – 48%) -
Erythrocyte Recovery
at Day 100 65%
(95% CI 58% – 71%) - -
Median time to
Neutrophil Recovery 27 days 25 days 20 days
Median time to
Platelet Recovery
(20,000/uL) 90 days - 45 days
Median time to
Platelet Recovery
(50,000/uL) 113 days 122 days -
Median time to
Erythrocyte Recovery 64 days - -
16 HOW SUPPLIED/STORAGE AND HANDLING
HEMACORD is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 5 x 108 total nucleated cells with a minimum of 1.25 x 106 viable CD34+ cells in a volume of 25 milliliters (NDC# 76489-001-01). The exact pre-cryopreservation nucleated cell content is provided on the container label and accompanying records.
Store HEMACORD at or below -150°C until ready for thawing and preparation.
17 PATIENT COUNSELING INFORMATION
Discuss the following with patients receiving HEMACORD:
•Report immediately any signs and symptoms of acute infusion reactions, such as fever, chills, fatigue, breathing problems, dizziness, nausea, vomiting, headache, or muscle aches.
•Report immediately any signs or symptoms suggestive of graft-vs-host disease, including rash, diarrhea, or yellowing of the eyes.
INSTRUCTIONS FOR PREPARATION FOR INFUSION
1 REQUIRED EQUIPMENT, REAGENTS, AND SUPPLIES
Equipment
Biological Safety Cabinet (BSC)
Refrigerated blood bank centrifuge
Plasma extractor
Digital balance
Tube sealer compatible with PVC plastic
Automated cell counter
Microscope and chamber for determining cell count and viability (optional)
Water bath (4 liters or more)
Canister opening tool
Orbital Rotat |
