Display Panel
NDC 0007-3261-01
Iodine I 131 Tositumomab
DOSIMETRIC
For use only as part of dosimetric step in BEXXAR® therapeutic regimen.
For Intravenous Use Only
Rx only
Single-use vial
Contains No Preservatives
Store Frozen at < -20oC
CAUTION: Radioactive Material
Each vial contains 0.1 - 0.25 mg/mL Tositumomab, 0.61 -0.75 mCi/mL Iodine-131,
4.4 - 6.6% (w/v) povidone, 1 - 2 mg/mL maltose, 8.5 -9.5 mg/mL sodium chloride, and
0.9 – 1.3 mg/mL ascorbic acid in 20.0 – 24.4 mL.
See Product Specification Sheet for lot specific protein and activity concentrations.
See package insert for full prescribing information.
GlaxoSmithKline
Research Triangle Park, NC 27709
US Lic. 1727
A027580
Principal Display Panel
NDC 0007-3262-01
Iodine I 131 Tositumomab
THERAPEUTIC
For use only as part of therapeutic step in BEXXAR® therapeutic regimen.
For Intravenous Use Only
Rx only
Single-use vial
Contains No Preservatives
Store Frozen at < -20oC
CAUTION: Radioactive Material
Each vial contains 1.1 - 2.5 mg/mL Tositumomab, 5.9 - 6.9 mCi/mL Iodine-131,
4.4 - 6.6% (w/v) povidone, 9 - 15 mg/mL maltose, 8.5 -9.5 mg/mL sodium chloride, and
0.9 – 1.3 mg/mL ascorbic acid in 20.0 – 24.4 mL.
See Product Specification Sheet for lot specific protein and activity concentrations.
See package insert for full prescribing information.
GlaxoSmithKline
Research Triangle Park, NC 27709
US Lic. 1727
A027519
BEXXAR
tositumomab kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0007-3260
Packaging
# NDC Package Description Multilevel Packaging
1 0007-3260-31 1 KIT In 1 PACKAGE, COMBINATION None
2 0007-3260-36 1 KIT In 1 PACKAGE, COMBINATION None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 2 VIAL, SINGLE-USE 32.2 mL
Part 2 1 VIAL, SINGLE-USE 2.5 mL
Part 1 of 2
BEXXAR
tositumomab injection
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOSITUMOMAB (TOSITUMOMAB) TOSITUMOMAB 14 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MALTOSE
SODIUM CHLORIDE
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 16.1 mL In 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125011 07/15/2009
Part 2 of 2
BEXXAR
tositumomab injection
Product Information
Route of Administration INTRAVENOUS DEA Schedule
