Calculation of Iodine-131 Activity for the Therapeutic Dose

The following equation is used to calculate the activity of Iodine-131 required for delivery of the desired total body dose of radiation.

HOW SUPPLIED
TOSITUMOMAB DOSIMETRIC PACKAGING

The components of the dosimetric step will be shipped ONLY to individuals who are participating in the certification program or have been certified in the preparation and administration of the BEXXAR therapeutic regimen. The components are shipped from separate sites; when ordering, ensure that the components are scheduled to arrive on the same day. The components of the Tositumomab Dosimetric Step include:

Tositumomab: Two single-use 225 mg vials (16.1 mL) and one single-use 35 mg vial (2.5 mL) of Tositumomab at a protein concentration of 14 mg/mL supplied by McKesson BioServices.
NDC 0007-3260-31

Iodine I 131 Tositumomab: A single-use vial of Iodine I 131 Tositumomab within a lead pot, supplied by MDS Nordion. Each single-use vial contains not less than 20 mL of Iodine I 131 Tositumomab at nominal protein and activity concentrations of 0.1 mg/mL and 0.61 mCi/mL (at calibration), respectively. (Refer to the product specification sheet for the lot-specific protein concentration, activity concentration, total activity and expiration date.)
NDC 0007-3261-01

TOSITUMOMAB THERAPEUTIC PACKAGING

The components of the therapeutic step will be shipped ONLY to individuals who are participating in the certification program or have been certified in the preparation and administration of the BEXXAR therapeutic regimen for an individual patient who has completed the Dosimetric Step. The components of the therapeutic step are shipped from separate sites; when ordering, ensure that the components are scheduled to arrive on the same day. The components of the Tositumomab Therapeutic Step include:

Tositumomab: Two single-use 225 mg vials (16.1 mL) and one single-use 35 mg vial (2.5 mL) of Tositumomab at a protein concentration of 14 mg/mL supplied by McKesson BioServices.
NDC 0007-3260-36

Iodine I 131 Tositumomab: One or two single-use vials of Iodine I 131 Tositumomab within a lead pot(s), supplied by MDS Nordion. Each single-use vial contains not less than 20 mL of Iodine I 131 Tositumomab at nominal protein and activity concentrations of 1.1 mg/mL and 5.6 mCi/mL (at calibration), respectively. Refer to the product specification sheet for the lot-specific protein concentration, activity concentration, total activity and expiration date.
NDC 0007-3262-01

STABILITY AND STORAGE
TOSITUMOMAB

Vials of Tositumomab (35 mg and 225 mg) should be stored refrigerated at 2oC-8oC (36oF-46oF) prior to dilution. Do not use beyond expiration date. Protect from strong light. DO NOT SHAKE. Do not freeze. Discard any unused portions left in the vial.

Solutions of diluted Tositumomab are stable 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. However, it is recommended that the diluted solution be stored refrigerated at 2°C-8°C (36°F-46°F) prior to administration because it does not contain preservatives. Any unused portion must be discarded. Do not freeze solutions of diluted Tositumomab.

IODINE I 131 TOSITUMOMAB

Store frozen in the original lead pots. The lead pot containing the product must be s