Difference between revisions of "Tositumomab and I-131 (Bexxar)"
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| − | + | '''Note: GlaxoSmithKline plans to discontinue the manufacture and sale of the BEXXAR therapeutic regimen (tositumomab and iodine I 131 tositumomab). The last day to schedule dosing for BEXXAR will be February 11, 2014 with final patient-availability on February 20, 2014. More information [http://www.bexxar.com/ here].''' | |
==General information== | ==General information== | ||
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*12/22/2004: FDA labeling revised to include patients with relapsed or refractory, low grade, follicular or transformed CD20 positive non-Hodgkin's lymphoma who have not received [[Rituximab (Rituxan)]] | *12/22/2004: FDA labeling revised to include patients with relapsed or refractory, low grade, follicular or transformed CD20 positive non-Hodgkin's lymphoma who have not received [[Rituximab (Rituxan)]] | ||
*8/15/2012: FDA labeling revised to remove 12/22/2004 addition for rituximab-naive patients. | *8/15/2012: FDA labeling revised to remove 12/22/2004 addition for rituximab-naive patients. | ||
| + | |||
| + | ==Also known as== | ||
| + | *BEXXAR | ||
| + | *tositumomab and I 131 tositumomab | ||
| + | *tositumomab and iodine-131 tositumomab. | ||
==References== | ==References== | ||
<references/> | <references/> | ||
Revision as of 16:41, 15 November 2013
Note: GlaxoSmithKline plans to discontinue the manufacture and sale of the BEXXAR therapeutic regimen (tositumomab and iodine I 131 tositumomab). The last day to schedule dosing for BEXXAR will be February 11, 2014 with final patient-availability on February 20, 2014. More information here.
General information
Class/mechanism: Radioimmunotherapy; treatment regimen that includes two separate steps: first, a dosimetric dose with an anti-CD20 antibody (tositumomab) alone, and second, a therapeutic dose with tositumomab bound to a radioactive isotope, iodone-131 (I-131). Tositumomab binds to the extracellular domain of the CD20 molecule expressed on B-cells and may induce complement-dependent cytotoxicity (CDC) and/or antibody-dependent cell mediated cytotoxicity (ADCC). The I-131 that is bound to tositumomab emits ionizing radiation, leading to cell death.[1][2]
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Tositumomab and I-131 (Bexxar) patient drug information (Chemocare)[3]
- Tositumomab and I-131 (Bexxar) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 6/27/2003: Granted FDA accelerated approval for the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab (Rituxan) and has relapsed following chemotherapy.
- 12/22/2004: FDA labeling revised to include patients with relapsed or refractory, low grade, follicular or transformed CD20 positive non-Hodgkin's lymphoma who have not received Rituximab (Rituxan)
- 8/15/2012: FDA labeling revised to remove 12/22/2004 addition for rituximab-naive patients.
Also known as
- BEXXAR
- tositumomab and I 131 tositumomab
- tositumomab and iodine-131 tositumomab.