he 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 solutions 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 Therapeutic Dose
Required materials not supplied:
A. Lead shielding for preparation vial and syringe pump
B. One or two 30 mL syringes with 18-gauge needles to withdraw the calculated volume of Iodine I 131 Tositumomab from the Iodine I 131 Tositumomab vial(s). One or two 60 mL syringes with 18-gauge needles 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 sterile syringe with attached needle to draw up Tositumomab from the 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 therapeutic vial with appropriate lead shielding.
Calculate the dose of Iodine I 131 Tositumomab required (see CALCULATION OF IODINE-131 ACTIVITY FOR THERAPEUTIC DOSE).
Based on the activity concentration of the vial (see actual product specification sheet for each vial supplied in the therapeutic package), calculate the volume required for the Iodine I 131 Tositumomab activity required for the therapeutic dose.
Using one or more 30 mL syringes with an 18-gauge needle, 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 the calculated dose (±10%) needed for the therapeutic step, proceed with step 7.
Calculate the amount of Tositumomab protein contained in the solution of Iodine I 131 Tositumomab in the shielded preparation vial, based on the volume and protein concentration (see product specification sheet).
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.
Note: If the dose of Iodine I 131 Tositumomab requires the use of 2 vials of Iodine I 131 Tositumomab or the entire contents of a single vial of Iodine I 131 Tositumomab, there may be no need to add protein from the 35 mg vial of Tositumomab.
Using the 20 mL syringe containing 0.9% Sodium Chloride for Injection, USP, add a sufficient volume (if needed) to the shielded preparation vial to yield a final volume of 30 mL. Gently mix the solution.
Withdraw the entire vol
