Required materials not supplied: For questions about required materials call the BEXXAR Service Center at 1-877-423-9927.

A. IV Filter set (0.22 micron filter), 15 inch with injection site (port) and luer lock

B. One Primary IV infusion set

C. One 100 mL bag of sterile 0.9% Sodium Chloride for Injection, USP

D. Two Secondary IV infusion sets

E. One IV Extension set, 30 inch luer lock

F. One 3-way stopcock

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

H. One Infusion pump for Tositumomab infusion

I. One Syringe Pump for Iodine I 131 Tositumomab infusion

J. Lead shielding for use in the administration of the dosimetric dose

Tositumomab Infusion:

(See Figure 1 in the “Workbook for Dosimetry Methodology and Administration Set-Up” for diagrammatic illustration of the configuration of the infusion set components.)

Attach a primary IV infusion set (Item B) to the 0.22 micron in-line filter set (Item A) and the 100 mL bag of sterile 0.9% Sodium Chloride for Injection, USP (Item C).
After priming the primary IV infusion set (Item B) and IV filter set (Item A), connect the infusion bag containing 450 mg Tositumomab (50 mL) via a secondary IV infusion set (Item D) to the primary IV infusion set (Item B) at a port distal to the 0.22 micron in-line filter. Infuse Tositumomab over 60 minutes.
After completion of the Tositumomab infusion, disconnect the secondary IV infusion set (Item D) and flush the primary IV infusion set (Item B) and the in-line IV filter set (Item A) with sterile 0.9% Sodium Chloride for Injection, USP. Discard the Tositumomab bag and secondary IV infusion set.
Iodine I 131 Tositumomab Dosimetric Infusion:

(See Figure 2 in the “Workbook for Dosimetry Methodology and Administration Set-Up” for diagrammatic illustration of the configuration of the infusion set components.)

Appropriate shielding should be used in the administration of the dosimetric dose.
The dosimetric dose is delivered in a 60 mL syringe.
Connect the extension set (Item E) to the 3-way stopcock (Item F).
Connect the 50 mL bag of sterile 0.9% Sodium Chloride for Injection, USP (Item G) to a secondary IV infusion set (Item D) and connect the infusion set to the 3-way stopcock (Item F). Prime the secondary IV infusion set (Item D) and the extension set (Item E). Connect the extension set (Item E) to a port in the primary IV infusion set (Item B), distal to the filter.
(Note: You must use the same primary infusion set (Item B) and IV filter set (Item A) with pre-wetted filter that was used for the Tositumomab infusion. A change in filter can result in loss of up to 7% of the Iodine I 131 Tositumomab dose.)

Attach the syringe filled with the Iodine I 131 Tositumomab to the 3-way stopcock (Item F)
Set syringe pump to deliver the entire 5.0 mCi (35 mg) dose of Iodine I 131 Tositumomab over 20 minutes.
After completion of the infusion of Iodine I 131 Tositumomab, close the stopcock (Item F) to the syringe. Flush the extension set (Item E) and the secondary IV infusion set (Item D) with 0.9% Sodium Chloride for Injection, USP from the 50 mL bag (Item G).
After the flush, disconnect the extension set (Item E), 3-way stopcock (Item F) and syringe. Disconnect the primary IV infusion set (Item B) and in-line filter set (Item A). Determine the combined residual activity of the syringe and infusion set components (stopcock, extension set, primary infusion set and in-line filter set) b