B. One 50 mL bag of sterile 0.9% Sodium Chloride for Injection, USP

C. One 50 mL syringe for drawing up 32 mL of saline for disposal from the 50 mL bag of sterile 0.9% Sodium Chloride for Injection, USP

Method:

Withdraw and dispose of 32 mL of saline from a 50 mL bag of sterile 0.9% Sodium Chloride for Injection, USP.
Withdraw the entire contents from each of the two 225 mg vials (a total of 450 mg Tositumomab in 32 mL) and transfer to the infusion bag containing 18 mL of 0.9% Sodium Chloride for Injection, USP to yield a final volume of 50 mL.
Gently mix the solution by inverting/rotating the bag. DO NOT SHAKE.
The diluted Tositumomab may be stored for up to 24 hours when stored refrigerated at 2°C−8°C (36°F−46°F) and for up to 8 hours at room temperature.
Note: Tositumomab solution may contain particulates that are generally white in nature. The product should appear clear to opalescent, colorless to slightly yellow.

Preparation of Iodine I 131 Tositumomab Dosimetric Dose

Required materials not supplied:

A. Lead shielding for preparation vial and syringe pump

B. One 30 mL syringe with 18-gauge needle to withdraw the calculated volume of Iodine I 131 Tositumomab from the Iodine I 131 Tositumomab vial. One 60 mL syringe with 18-gauge needle to withdraw the volume from the preparation vial for administration

C. One 20 mL syringe with attached needle, filled with 0.9% Sodium Chloride for Injection, USP

D. One 3 mL syringe with attached needle to withdraw Tositumomab from 35 mg vial

E. One sterile, 30 or 50 mL preparation vial

F. Two lead pots, both kept at room temperature. One pot is used to thaw the labeled antibody and the second pot is used to hold the preparation vial

Method:

Allow approximately 60 minutes for thawing (at ambient temperature) of the Iodine I 131 Tositumomab dosimetric vial with appropriate lead shielding.
Based on the activity concentration of the vial (see actual product specification sheet for the vial supplied in the dosimetric package), calculate the volume required for an Iodine I 131 Tositumomab activity of 5.0 mCi.
Withdraw the calculated volume from the Iodine I 131 Tositumomab vial.
Transfer this volume to the shielded preparation vial.
Assay the dose to ensure that the appropriate activity (mCi) has been prepared.
a. If the assayed dose is 5.0 mCi (±10%) proceed with step 6.

Calculate the amount of Tositumomab contained in the solution of Iodine I 131 Tositumomab in the shielded preparation vial, based on the volume and protein concentration (see actual product specification sheet supplied in the dosimetric package).
If the shielded preparation vial contains less than 35 mg, calculate the amount of additional Tositumomab needed to yield a total of 35 mg protein. Calculate the volume needed from the 35 mg vial of Tositumomab, based on the protein concentration. Withdraw the calculated volume of Tositumomab from the 35 mg vial of Tositumomab, and transfer this volume to the shielded preparation vial. The preparation vial should now contain a total of 35 mg of Tositumomab.
Using the 20 mL syringe containing 0.9% Sodium Chloride for Injection, USP, add a sufficient quantity to the shielded preparation vial to yield a final volume of 30 mL. Gently mix the solutions.
Withdraw the entire contents from the preparation vial into a 60 mL syringe using a large bore needle (18-gauge).
Assay and record the activity.
Administration