Vazculep

For intravenous use only. Do not irradiate.

Unit selection and administration of DUCORD should be done under the direction of a physician experienced in hematopoietic progenitor cell transplantation.

2.1 Dosing

The recommended minimum dose is 2.5 × 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 DUCORD are documented on the container label and/or in accompanying records.

2.2 Preparation for Infusion

DUCORD should be prepared by a trained healthcare professional.

Do not irradiate DUCORD. See the appended detailed instructions for preparation of DUCORD for infusion. Once prepared for infusion, DUCORD may be stored at 4 to 8 °C for up to 30 minutes if product is thawed and DMSO is not removed, at 4 to 8 °C for up to 1 hour if DUCORD is thawed and diluted to reduce DMSO concentration, and at 4 to 8 °C for up to 4 hours if DMSO is removed in a washing procedure [see Instructions for Preparation for Infusion]. The recommended limit on DMSO administration is 1 gram per kg body weight per day. [See Warnings and Precautions (5.2) and Overdosage (10 ] 2.3 Administration

DUCORD should be administered under the supervision of a qualified healthcare professional experienced in hematopoietic progenitor cell transplantation.

Confirm the identity of the patient for the specified unit of DUCORD prior to administration. Confirm that emergency medications are available for use in the immediate area. Ensure the patient is hydrated adequately. Premedicate the patient 30 to 60 minutes before the administration of DUCORD. Premedication should include any or all of the following: antipyretic, histamine antagonists, and corticosteroids. 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. Administer DUCORD by intravenous infusion. Do not administer in the same tubing concurrently with products other than 0.9% Sodium Chloride, Injection (USP). DUCORD may be filtered through a 170 to 260 micron filter designed to remove clots. Do NOT use a filter designed to remove leukocytes. DUCORD should be infused over 15 to 60 minutes depending on the volume of the product and the weight of the patient. The rate of infusion should not exceed a maximum of 5 milliliters per kilogram per hour. 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 (5.2) and Adverse Reactions (6)] Monitor the patient for adverse reactions during, and for at least six hours after, administration. Because DUCORD contains lysed red cells that may cause renal failure, careful monitoring of urine output is also recommended.

NOTE: If product is being prepared for a multi-unit infusion, infuse units independently.

Should a reaction occur, appropriately manage the reaction before the second unit is thawed for infusion.