t. After injection, flush the line with at least 10 mL of normal saline.
If platelet count ≥150,000/mm3, administer Y-90 Zeva lin over 10 minutes as an intravenous injection at a dose of Y-90 0.4 mCi per kg (14.8 MBq per kg) actual body weight.
If platelet count 100,000-149,000/mm3, in relapsed or refractory patients, administer Y-90 Zeva lin over 10 minutes as an intravenous injection at a dose of Y-90 0.3 mCi per kg (11.1 MBq per kg) actual body weight.
Do not administer more than 32 mCi (1184 MBq) Y-90 Zeva lin dose regardless of the patient’s body weight.
Monitor patients closely for evidence of extravasation during the injection of Y-90 Zeva lin. Immediately stop infusion and restart in another limb if any signs or symptoms of extravasation occur [see Warnings and Precautions (5.7)].
2.3 Directions for Preparation of Radiolabeled In-111 and Y-90 Zeva lin Doses
Two separate and distinctly-labeled kits are required for preparation of Indium-111 (In-111) Zeva lin and Yttrium-90 (Y-90) Zeva lin. Follow the detailed instructions for the preparation of radiolabeled Zeva lin [see Dosage and Administration (2.4)]. The procedures are different for the preparation of In-111 Zeva lin and of Y-90 Zeva lin.
Directions for Preparation of Radiolabeled In-111 Zeva lin Dose
Required materials not supplied in the kit:
Indium-111 Chloride Sterile Solution (In-111 Chloride) from GE Healthcare, or Mallinckrodt/Covidien
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 lead shielding for reaction vial and syringe for In-111
Method:
Allow contents of the refrigerated In-111 Zeva lin kit (Zeva lin vial, 50 mM sodium acetate vial, formulation buffer vial, and empty reaction vial) to reach room temperature.
Place the empty reaction vial in an appropriate lead shield.
Determine the amount of each component needed:
Calculate volume of In-111 Chloride equivalent to 5.5 mCi based on the activity concentration of the In-111 Chloride stock.
The volume of 50 mM Sodium Acetate solution needed is 1.2 times the volume of In-111 Chloride solution determined in step 3.a, above.
Calculate 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 of Sodium Acetate to the empty reaction vial. Coat the entire inner surface of the reaction vial by gentle inversion or rolling.
Transfer 5.5 mCi of In-111 Chloride to the reaction vial using a lead shielded syringe. Mix the two solutions by gentle inversion or rolling.
Transfer 1 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 30 minutes. A shorter or longer reaction time may adversely alter the final labeled product.
Immediately after the 30-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 acti |
