vity using a radioactivity calibration system suitable for the measurement of In-111.
Using supplied labels, record the date and time of preparation, total activity and volume, date and time of expiration, and affix these labels to the shielded reaction vial container.
Patient Dose: Calculate the volume required for an In-111 Zeva lin dose of 5 mCi. Withdraw the required volume from the reaction vial into a sterile syringe. Assay the syringe in a dose calibrator suitable for the measurement of In-111. Using the supplied labels, record patient identifier, total activity and volume and the date and time of expiration, and affix these labels to the syringe and shielded unit dose container.
Determine Radiochemical Purity [see Dosage and Administration (2.4)].
Store Indium-111 Zeva lin at 2-8°C (36-46°F) until use and administer within 12 hours of radiolabeling. Immediately prior to administration, assay the syringe and contents using an appropriate radioactivity calibration system.
Directions for Preparation of Radiolabeled Y-90 Zeva lin Dose
Required materials not supplied in the kit:
Yttrium-90 Chloride Sterile Solution from MDS Nordion
Three sterile 1 mL plastic syringes
One sterile 3 mL plastic syringe
Two sterile 10 mL plastic syringes with 18-20 G needles
Instant thin-layer chromatographic silica gel strips (ITLC-SG)
0.9% Sodium Chloride aqueous solution for the chromatography solvent
Developing chamber for chromatography
Suitable radioactivity counting apparatus
Filter, 0.22 micrometer, low-protein-binding
Appropriate acrylic shielding for reaction vial and syringe for Y-90
Method:
Allow contents of the refrigerated Y-90 Zeva lin kit (Zeva lin vial, 50 mM sodium acetate vial, and formulation buffer vial) to reach room temperature.
Place the empty reaction vial in an appropriate acrylic shield.
Determine the amount of each component needed:
Calculate volume of Y-90 Chloride equivalent to 40 mCi based on the activity concentration of the Y-90 Chloride stock.
The volume of 50 mM Sodium Acetate solution needed is 1.2 times the volume of Y-90 Chloride solution determined in step 3.a, above.
Calculate the volume of formulation buffer needed to bring the reaction vial contents to a final volume of 10 mL.
Transfer the calculated volume of 50 mM Sodium Acetate to the empty reaction vial. Coat the entire inner surface of the reaction vial by gentle inversion or rolling.
Transfer 40 mCi of Y-90 Chloride to the reaction vial using an acrylic shielded syringe. Mix the two solutions by gentle inversion or rolling.
Transfer 1.3 mL of Zeva lin (ibritumomab tiuxetan) to the reaction vial. Do not shake or agitate the vial contents.
Allow the labeling reaction to proceed at room temperature for 5 minutes. A shorter or longer reaction time may adversely alter the final labeled product.
Immediately after the 5-minute incubation period, transfer the calculated volume of formulation buffer from step 3.c. to the reaction vial. Gently add the formulation buffer down the side of the reaction vial. If necessary, withdraw an equal volume of air to normalize pressure.
Measure the final product for total activity using a radioactivity calibration system suitable for the measurement of Y-90.
Using the supplied labels, record the date and time of preparation, the total activity and volume, and the date and time of expiration, and affix these labels to the shielded reaction vial container.
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