Note: Restrictions on patient contact with others and release from the hospital must follow all applicable federal, state, and institutional regulations.

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

A. One 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 therapeutic 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 a 100 mL bag of sterile 0.9% Sodium Chloride for Injection, USP (Item C).
After priming the primary IV infusion set (Item B) and 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 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 Therapeutic 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 therapeutic dose.
The therapeutic dose is delivered in one or more 60 mL syringes.
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 therapeutic dose of Iodine I 131 Tositumomab over 20 minutes. (Note: If more than one syringe is required, remove the syringe and repeat steps 5 and 6.)
After completion of the infusion of Iodine I 131 Tositumomab, close the stopcock (Item F) to the syringe. Flush the secondary IV infusion set (Item D) and the extens