Difference between revisions of "Ruxolitinib (Jakafi)"
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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.<ref name="insert"></ref><ref>[http://www.jakafi.com/ Jakafi manufacturer's website]</ref> | 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><ref>[http://www.jakafi.com/ Jakafi manufacturer's website]</ref> | ||
| + | |||
| + | ==Diseases for which it is established== | ||
| + | *[[Graft versus host disease]] | ||
| + | *[[Myelofibrosis]] | ||
| + | *[[Polycythemia vera]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Acute myeloid leukemia]] | *[[Acute myeloid leukemia]] | ||
*[[Chronic lymphocytic leukemia]] | *[[Chronic lymphocytic leukemia]] | ||
| − | *[[ | + | *[[Essential thrombocythemia]] |
*[[Hypereosinophilic syndrome]] | *[[Hypereosinophilic syndrome]] | ||
| − | |||
| − | |||
==Patient drug information== | ==Patient drug information== | ||
Revision as of 13:37, 25 February 2023
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 established
Diseases for which it is used
- Acute myeloid leukemia
- Chronic lymphocytic leukemia
- Essential thrombocythemia
- Hypereosinophilic syndrome
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. (Based on COMFORT-I and COMFORT-II)
- 12/4/2014: Indication expanded for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea (HU). (New disease entity; based on RESPONSE)
- 5/24/2019: Indication expanded for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. (New condition; based on REACH1)
- 9/21/2021: Approved for chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. (Based on REACH3)
History of changes in EMA indication
- 8/23/2012: Initial authorization
Also known as
- Code name: INCB018424
- Generic name: ruxolitinib phosphate
- Brand names: Jakafi, Jakavi
References
Categories:
- Drugs
- Oral medications
- JAK inhibitors
- Acute myeloid leukemia medications
- Chronic lymphocytic leukemia medications
- Graft versus host disease medications
- Essential thrombocythemia medications
- Hypereosinophilic syndrome medications
- Myelofibrosis medications
- Polycythemia vera medications
- FDA approved in 2011
- EMA approved in 2012
- PMDA approved drugs