ate.
2.1 Dosing
The recommended minimum dose is 2.5 x 107 nucleated cells/kg at cryopreservation. Multiple units may be required in order to achieve the appropriate dose.
Matching for at least 4 of 6 HLA-A antigens, HLA-B antigens, and HLA-DRB1 alleles is recommended. The HLA typing and nucleated cell content for each individual unit of HEMACORD are documented on the container label and/or in accompanying records.
2.2 Preparation for Infusion
HEMACORD should be prepared by a trained healthcare professional.
•Do not irradiate HEMACORD.
•See the appended detailed instructions for preparation of HEMACORD for infusion.
•Once prepared for infusion, HEMACORD may be stored at 4 to 25°C for up to 4 hours if DMSO is not removed, and at 4°C for up to 24 hours if DMSO is removed in a washing procedure.
•The recommended limit on DMSO administration is 1 gram per kg body weight per day. [See Warnings and Precautions (5.2)]
2.3 Administration
HEMACORD should be administered under the supervision of a qualified healthcare professional experienced in hematopoietic progenitor cell transplantation.
1.Confirm the identity of the patient for the specified unit of HEMACORD prior to administration.
2.Confirm that emergency medications are available for use in the immediate area.
3.Ensure the patient is hydrated adequately.
4.Premedicate the patient 30 to 60 minutes before the administration of HEMACORD. Premedications can include any or all of the following: antipyretic, histamine blocker, and corticosteroids.
5.Inspect the product for any abnormalities such as unusual particulates and for breaches of container integrity prior to administration. Prior to infusion, discuss all such product irregularities with the laboratory issuing the product for infusion.
6.Administer HEMACORD by intravenous infusion. Do not administer in the same tubing concurrently with products other than 0.9% Sodium Chloride, Injection (USP). HEMACORD may be filtered through a 170 to 260 micron filter designed to remove clots. Do NOT use a filter designed to remove leukocytes.
7.For adults, begin infusion of HEMACORD at 100 milliliters per hour and increase the rate as tolerated. For children, begin infusion of HEMACORD at 1 milliliter per kg per hour and increase as tolerated. The infusion rate should be reduced if the fluid load is not tolerated. The infusion should be discontinued in the event of an allergic reaction or if the patient develops a moderate to severe infusion reaction. [See Warnings and Precautions (5) and Adverse Reactions (6)]
8.Monitor the patient for adverse reactions during, and for at least six hours after, administration. Because HEMACORD contains lysed red cells that may cause renal failure, careful monitoring of urine output is also recommended.
3 DOSAGE FORMS AND STRENGTHS
Each unit of HEMACORD contains a minimum of 5.0 x 108 total nucleated cells with a minimum of 1.25 x 106 viable CD34+ cells, suspended in 10% dimethyl sulfoxide (DMSO) and 1% Dextran 40, at the time of cryopreservation.
The exact pre-cryopreservation nucleated cell content is provided on the container label and in accompanying records.
4 CONTRAINDICATIONS
HEMACORD is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40 or plasma proteins. [See Description (11) and Dosage and Administration (2.2)]
5 WARNINGS AND PRECAUTIONS
5.1 Allergic Reactions and Anaphylaxis
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