Difference between revisions of "Ibrutinib (Imbruvica)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *11/13/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm374857.htm FDA granted accelerated approval] "for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy." | + | *11/13/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm374857.htm FDA granted accelerated approval] "for the treatment of patients with [[Mantle cell lymphoma | mantle cell lymphoma (MCL)]] who have received at least one prior therapy." |
| − | *2/12/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm385878.htm FDA granted accelerated approval] "for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy." | + | *2/12/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm385878.htm FDA granted accelerated approval] "for the treatment of patients with [[Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) | chronic lymphocytic leukemia (CLL)]] who have received at least one prior therapy." |
| + | *7/28/2014: Approval expanded to include patients with [[Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) | chronic lymphocytic leukemia (CLL)]] who carry a deletion in chromosome 17 (17p deletion). | ||
==Also known as== | ==Also known as== | ||
Revision as of 13:59, 4 August 2014
General information
Class/mechanism: Irreversible inhibitor of Bruton's tyrosine kinase (BTK), which is an enzyme that participates in the B-cell receptor (BCR) signal cascade and cytokine receptor pathways. BCR signaling is believed to promote cell proliferation, adhesion, and survival in B-cell malignancies. Inhibition of BTK interferes with the processes above, as well as B-cell chemotaxis and trafficking.[1][2][3]
[4]
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.[1]
Patient drug information
- Ibrutinib (Imbruvica) package insert PDF pages 18-19[1]
- Ibrutinib (Imbruvica) patient drug information (Chemocare)[5]
- Ibrutinib (Imbruvica) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 11/13/2013: FDA granted accelerated approval "for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy."
- 2/12/2014: FDA granted accelerated approval "for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy."
- 7/28/2014: Approval expanded to include patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion).
Also known as
PCI-32765
References
- ↑ 1.0 1.1 1.2 Ibrutinib (Imbruvica) package insert
- ↑ Ibrutinib (Imbruvica) package insert (locally hosted backup)
- ↑ Imbruvica manufacturer's website
- ↑ Pharmacyclics BTK inhibitor website
- ↑ Ibrutinib (Imbruvica) patient drug information (Chemocare)
- ↑ Ibrutinib (Imbruvica) patient drug information (UpToDate)