tored in a freezer at a temperature of -20oC or below until it is removed for thawing prior to administration to the patient. Do not use beyond the expiration date on the label of the lead pot.
Thawed dosimetric and therapeutic doses of Iodine I 131 Tositumomab are stable for up to 8 hours at 2°C-8°C (36°F-46°F) or at room temperature. Solutions of Iodine I 131 Tositumomab diluted for infusion contain no preservatives and should be stored refrigerated at 2°C-8°C (36°F-46°F) prior to administration (do not freeze). Any unused portion must be discarded according to federal and state laws.
REFERENCES
Weber DA, Eckman KF, Dillman LT, Ryman JC. In: MIRD: radionuclide data and decay schemes. New York: Society of Nuclear Medicine Inc. 1989:229.
Tedder T, Boyd A, Freedman A, Nadler L, Schlossman S. The B cell surface molecule is functionally linked with B cell activation and differentiation. J Immunol 1985;135(2):973-979.
Anderson, KC, Bates MP, Slaughenhoupt BL, Pinkus GS, Schlossman SF, Nadler LM. Expression of human B cell-associated antigens on leukemias and lymphomas: a model of human B cell differentiation. Blood 1984;63(6):1424-1433.
Press OW, Howell-Clark J, Anderson S, Bernstein I. Retention of B-cell-specific monoclonal antibodies by human lymphoma cells. Blood 1994;83:1390−7.
Cardarelli PM, Quinn M, Buckman D, Fang Y, Colcher D, King DJ, Bebbington C, et al. Binding to CD20 by anti-B1 antibody or F(ab')(2) is sufficient for induction of apoptosis in B-cell lines. Cancer Immunol Immunother 2002 Mar;51(1):15-24.
Stashenko P, Nadler LM, Hardy R, Schlossman SF. Characterization of a human B lymphocyte-specific antigen. J Immunol 1980;125:1678−85.
U.S. Lic. 1727
GlaxoSmithKline
Research Triangle Park, NC 27709
BEXXAR is a registered trademark of GlaxoSmithKline.
©2005, GlaxoSmithKline. All rights reserved.
October 2005 RL-2245
Principal Display Panel
NDC 0007-3260-31
Tositumomab
DOSIMETRIC
For use only as part of dosimetric step in BEXXAR® therapeutic regimen.
For Intravenous Use Only
Rx only
Each package contains one 35 mg vial and two 225 mg vials of Tositumomab.
Each single-use vial contains 14 mg/mL Tositumomab, 10% (w/v) maltose, 145 mM sodium chloride, 10 mM phosphate and Water for Injection, USP. No U.S. standard of potency.
Store at 2oC – 8oC (36oF – 46oF). Do Not Freeze. Protect from Light.
See package insert for full prescribing information.
Contains No Preservatives
GlaxoSmithKline
Research Triangle Park, NC 27709
US Lic. 1727
10000000027538
Principal Display Panel
NDC 0007-3260-36
Tositumomab
THERAPEUTIC
For use only as part of therapeutic step in BEXXAR® therapeutic regimen.
For Intravenous Use Only
Rx only
Each package contains one 35 mg vial and two 225 mg vials of Tositumomab.
Each single-use vial contains 14 mg/mL Tositumomab, 10% (w/v) maltose, 145 mM sodium chloride, 10 mM phosphate and Water for Injection, USP. No U.S. standard of potency.
Store at 2oC – 8oC (36oF – 46oF). Do Not Freeze. Protect from Light.
See package insert for full prescribing information.
Contains No Preservatives
GlaxoSmithKline
Research Triangle Park, NC 27709
US Lic. 1727
10000000027539
Principal
