Difference between revisions of "Ibritumomab tiuxetan (Zevalin)"
m |
Warner-admin (talk | contribs) m (Text replacement - "chemocare.com/chemotherapy/drug-info" to "chemocare.com/druginfo") |
||
(36 intermediate revisions by 5 users not shown) | |||
Line 1: | Line 1: | ||
==General information== | ==General information== | ||
− | Class/mechanism: Anti-CD20 antibody chelated by tiuxetan to a radioactive agent (Y-90, yttrium-90; or In-111, indium-111). | + | Class/mechanism: Anti-CD20 antibody chelated by tiuxetan to a radioactive agent (Y-90, yttrium-90; or In-111, indium-111). Y-90 emits beta radiation, which causes cellular damage via free radicals. This results in damage to cells which express the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35).<ref name="insert">[https://zevalin.com/wp-content/uploads/2019/04/PI-ZEVALIN-092019.pdf Ibritumomab tiuxetan (Zevalin) package insert]</ref><ref>[[:File:Ibritumomab.pdf | Ibritumomab tiuxetan (Zevalin) package insert (locally hosted backup)]]</ref><ref>[http://www.zevalin.com/ Zevalin manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: potential [[vesicant]] | <br>Extravasation: potential [[vesicant]] | ||
− | 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. | + | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
+ | |||
+ | ==Diseases for which it is established ''(work in progress)''== | ||
+ | *[[Follicular lymphoma]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
− | *[[ | + | *[[Diffuse large B-cell lymphoma]] |
+ | *[[Mantle cell lymphoma]] | ||
*[[Marginal zone lymphoma]] | *[[Marginal zone lymphoma]] | ||
− | |||
==Patient drug information== | ==Patient drug information== | ||
− | *[ | + | *[https://zevalin.com/wp-content/uploads/2019/04/PI-ZEVALIN-092019.pdf Ibritumomab tiuxetan (Zevalin) package insert]<ref name="insert"></ref> |
+ | *[https://chemocare.com/druginfo/ibritumomab.aspx Ibritumomab tiuxetan (Zevalin) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/ibritumomab.aspx Ibritumomab tiuxetan (Zevalin) patient drug information (Chemocare)]</ref> | ||
*[http://www.uptodate.com/contents/ibritumomab-patient-drug-information Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ibritumomab-patient-drug-information Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/ibritumomab-patient-drug-information Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ibritumomab-patient-drug-information Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
− | * | + | *2002-02-19: Granted FDA accelerated approval for the treatment of patients with relapsed or refractory [[:Category:Indolent lymphomas|low-grade]], [[Follicular lymphoma |follicular]], or [[Transformed lymphoma|transformed]] B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin’s lymphoma. ''(Based on Wiseman et al. 2002, Witzig et al. 2002a, Witzig et al. 2002b)'' |
− | * | + | **2009-09-03: Granted FDA full approval; label expanded for the treatment of previously untreated [[Follicular lymphoma | follicular NHL]] in patients who achieve a partial or complete response to first-line chemotherapy. ''(Based on FIT)'' |
+ | ==History of changes in EMA indication== | ||
+ | *2004-01-16: Initial authorization | ||
+ | *Uncertain date: [90Y]-radiolabelled Zevalin is indicated in adults as consolidation therapy after remission induction in previously untreated patients with [[follicular lymphoma]]. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. | ||
+ | *Uncertain date: [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ [[Follicular lymphoma|follicular B-cell non-Hodgkin's lymphoma (NHL)]]. | ||
+ | ==History of changes in PMDA indication== | ||
+ | *2008-01-25: Initial approval for the treatment of relapsed or refractory, CD20-positive lymphomas of the following: [[:Category:Indolent lymphomas|low-grade B-cell non-Hodgkin’s lymphoma]] and [[mantle cell lymphoma]]. | ||
+ | ==Also known as== | ||
+ | *'''Brand name:''' Zevalin | ||
==References== | ==References== | ||
<references/> | <references/> | ||
− | [[Category: | + | [[Category:Drugs]] |
− | [[Category: | + | |
− | [[Category: | + | [[Category:Intravenous medications]] |
− | [[Category: | + | |
+ | |||
+ | [[Category:Anti-CD20 radioimmunoconjugates]] | ||
+ | [[Category:Radiotherapy medications]] | ||
+ | [[Category:Diffuse large B-cell lymphoma medications]] | ||
[[Category:Follicular lymphoma medications]] | [[Category:Follicular lymphoma medications]] | ||
+ | [[Category:Mantle cell lymphoma medications]] | ||
[[Category:Marginal zone lymphoma medications]] | [[Category:Marginal zone lymphoma medications]] | ||
− | |||
− | [[Category: | + | [[Category:FDA approved in 2002]] |
+ | [[Category:EMA approved in 2004]] | ||
+ | [[Category:PMDA approved in 2008]] |
Latest revision as of 23:32, 2 September 2023
General information
Class/mechanism: Anti-CD20 antibody chelated by tiuxetan to a radioactive agent (Y-90, yttrium-90; or In-111, indium-111). Y-90 emits beta radiation, which causes cellular damage via free radicals. This results in damage to cells which express the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35).[1][2][3]
Route: IV
Extravasation: potential vesicant
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 established (work in progress)
Diseases for which it is used
Patient drug information
- Ibritumomab tiuxetan (Zevalin) package insert[1]
- Ibritumomab tiuxetan (Zevalin) patient drug information (Chemocare)[4]
- Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2002-02-19: Granted FDA accelerated approval for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin’s lymphoma. (Based on Wiseman et al. 2002, Witzig et al. 2002a, Witzig et al. 2002b)
- 2009-09-03: Granted FDA full approval; label expanded for the treatment of previously untreated follicular NHL in patients who achieve a partial or complete response to first-line chemotherapy. (Based on FIT)
History of changes in EMA indication
- 2004-01-16: Initial authorization
- Uncertain date: [90Y]-radiolabelled Zevalin is indicated in adults as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
- Uncertain date: [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
History of changes in PMDA indication
- 2008-01-25: Initial approval for the treatment of relapsed or refractory, CD20-positive lymphomas of the following: low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma.
Also known as
- Brand name: Zevalin
References
- ↑ 1.0 1.1 1.2 Ibritumomab tiuxetan (Zevalin) package insert
- ↑ Ibritumomab tiuxetan (Zevalin) package insert (locally hosted backup)
- ↑ Zevalin manufacturer's website
- ↑ Ibritumomab tiuxetan (Zevalin) patient drug information (Chemocare)
- ↑ Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)