Difference between revisions of "Zanubrutinib (Brukinsa)"
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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. | 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. | ||
| − | ==Diseases for which it is established | + | ==Diseases for which it is established== |
| + | *[[Chronic lymphocytic leukemia]] | ||
*[[Waldenström macroglobulinemia]] | *[[Waldenström macroglobulinemia]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | |||
*[[Mantle cell lymphoma]] | *[[Mantle cell lymphoma]] | ||
*[[Marginal zone lymphoma]] | *[[Marginal zone lymphoma]] | ||
| Line 17: | Line 17: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| + | ===[[Chronic lymphocytic leukemia]]=== | ||
| + | *1/19/2023: Approved for [[Chronic lymphocytic leukemia|chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)]]. ''(Based on SEQUOIA<sub>CLL</sub>)'' | ||
===[[Mantle cell lymphoma]]=== | ===[[Mantle cell lymphoma]]=== | ||
*11/14/2019: Accelerated approval for adult patients with [[mantle cell lymphoma|mantle cell lymphoma (MCL)]] who have received at least one prior therapy. ''(Based on BGB-3111-AU-003 & BGB-3111-206)'' | *11/14/2019: Accelerated approval for adult patients with [[mantle cell lymphoma|mantle cell lymphoma (MCL)]] who have received at least one prior therapy. ''(Based on BGB-3111-AU-003 & BGB-3111-206)'' | ||
Revision as of 12:26, 20 January 2023
General information
Class/mechanism: BTK inhibitor
Route: PO
Extravasation: n/a
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.
Diseases for which it is established
Diseases for which it is used
Patient drug information
History of changes in FDA indication
Chronic lymphocytic leukemia
- 1/19/2023: Approved for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (Based on SEQUOIACLL)
Mantle cell lymphoma
- 11/14/2019: Accelerated approval for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. (Based on BGB-3111-AU-003 & BGB-3111-206)
Marginal zone lymphoma
- 9/14/2021: Accelerated approval for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. (Based on MAGNOLIA and BGB-3111-AU-003)
Waldenström macroglobulinemia
- 8/31/2021: Approved for adult patients with Waldenström’s macroglobulinemia (WM). (Based on ASPEN)
History of changes in EMA indication
- 11/22/2021: Initial authorization
Also known as
- Code name: BGB-3111
- Brand name: Brukinsa