Difference between revisions of "Ruxolitinib (Jakafi)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
− | * 11/16/2011: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm280155.htm Initial FDA approval] for treatment of patients with intermediate or high-risk [[Myelofibrosis | myelofibrosis | + | * 11/16/2011: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm280155.htm Initial FDA approval] for treatment of patients with intermediate or high-risk [[Myelofibrosis | myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis]]. |
* 12/4/2014: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425677.htm FDA indication expanded] "for the treatment of patients with [[Polycythemia vera|polycythemia vera (PV)]] who have had an inadequate response to or are intolerant of [[Hydroxyurea (Hydrea)|hydroxyurea (HU)]]." | * 12/4/2014: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425677.htm FDA indication expanded] "for the treatment of patients with [[Polycythemia vera|polycythemia vera (PV)]] who have had an inadequate response to or are intolerant of [[Hydroxyurea (Hydrea)|hydroxyurea (HU)]]." | ||
==Also known as== | ==Also known as== | ||
− | INCB018424 | + | *'''Code name:''' INCB018424 |
+ | *'''Generic name:''' ruxolitinib phosphate | ||
+ | *'''Brand names:''' Jakafi, Jakavi | ||
==References== | ==References== | ||
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[[Category:Drug index]] | [[Category:Drug index]] | ||
− | |||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
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[[Category:Drugs FDA approved in 2011]] | [[Category:Drugs FDA approved in 2011]] | ||
+ | [[Category:PMDA approved drugs]] |
Revision as of 02:21, 11 August 2017
General information
Class/mechanism: Kinase inhibitor of Janus Associated Kinases (JAKs) JAK1 and JAK2. Modulates gene expression by interfering with the JAK signaling pathway, which involves recruitment, activation, and localization of STATs (signal transducers and activators of transcription) to cytokine receptors and the nucleus.[1][2]
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][3]
Diseases for which it is used
- Acute myeloid leukemia
- Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL)
- Hypereosinophilic syndrome
- Myelofibrosis
- Polycythemia vera
Patient drug information
- Patient information may be found in the Ruxolitinib (Jakafi) package insert[1]
- Ruxolitinib (Jakafi) patient drug information (Chemocare)[4]
- Ruxolitinib (Jakafi) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 11/16/2011: Initial FDA approval for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.
- 12/4/2014: FDA indication expanded "for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea (HU)."
Also known as
- Code name: INCB018424
- Generic name: ruxolitinib phosphate
- Brand names: Jakafi, Jakavi
References
- Drug index
- Oral medications
- Kinase inhibitors
- JAK inhibitors
- Acute myeloid leukemia medications
- Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) medications
- Hypereosinophilic syndrome medications
- Myelofibrosis medications
- Polycythemia vera medications
- Drugs FDA approved in 2011
- PMDA approved drugs