Difference between revisions of "Ruxolitinib (Jakafi)"
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<br>Extravasation: n/a | <br>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 | + | 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, [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== | ==Diseases for which it is established== | ||
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==Patient drug information== | ==Patient drug information== | ||
*Patient information may be found in the [https://www.jakafi.com/pdf/prescribing-information.pdf Ruxolitinib (Jakafi) package insert]<ref name="insert"></ref> | *Patient information may be found in the [https://www.jakafi.com/pdf/prescribing-information.pdf Ruxolitinib (Jakafi) package insert]<ref name="insert"></ref> | ||
| − | * [https://chemocare.com/ | + | * [https://chemocare.com/druginfo/ruxolitinib.aspx Ruxolitinib (Jakafi) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/ruxolitinib.aspx Ruxolitinib (Jakafi) patient drug information (Chemocare)]</ref> |
* [http://www.uptodate.com/contents/ruxolitinib-patient-drug-information Ruxolitinib (Jakafi) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ruxolitinib-patient-drug-information Ruxolitinib (Jakafi) patient drug information (UpToDate)]</ref> | * [http://www.uptodate.com/contents/ruxolitinib-patient-drug-information Ruxolitinib (Jakafi) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ruxolitinib-patient-drug-information Ruxolitinib (Jakafi) patient drug information (UpToDate)]</ref> | ||
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2012-08-23: Initial authorization | *2012-08-23: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2012-06-19: Initial notice of compliance | ||
==History of changes in PMDA indication== | ==History of changes in PMDA indication== | ||
| − | *2015-09-24: | + | *2014-07-04: Initial approval for the treatment of [[myelofibrosis]]. |
| + | *2015-09-24: New additional indication and a new dosage for the treatment of [[polycythemia vera]] (use only when conventional therapies are not sufficiently effective or inappropriate). | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' INCB-018424 |
*'''Generic name:''' ruxolitinib phosphate | *'''Generic name:''' ruxolitinib phosphate | ||
*'''Brand names:''' Jakafi, Jakavi | *'''Brand names:''' Jakafi, Jakavi | ||
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| − | [[Category: | + | [[Category:JAK1 inhibitors]] |
| + | [[Category:JAK2 inhibitors]] | ||
[[Category:Acute myeloid leukemia medications]] | [[Category:Acute myeloid leukemia medications]] | ||
| Line 55: | Line 59: | ||
[[Category:FDA approved in 2011]] | [[Category:FDA approved in 2011]] | ||
[[Category:EMA approved in 2012]] | [[Category:EMA approved in 2012]] | ||
| − | [[Category:PMDA approved | + | [[Category:Health Canada approved in 2012]] |
| + | [[Category:PMDA approved in 2014]] | ||
Latest revision as of 12:14, 29 June 2024
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
- 2011-11-16: 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)
- 2014-12-04: 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)
- 2019-05-24: 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)
- 2021-09-21: 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
- 2012-08-23: Initial authorization
History of changes in Health Canada indication
- 2012-06-19: Initial notice of compliance
History of changes in PMDA indication
- 2014-07-04: Initial approval for the treatment of myelofibrosis.
- 2015-09-24: New additional indication and a new dosage for the treatment of polycythemia vera (use only when conventional therapies are not sufficiently effective or inappropriate).
Also known as
- Code name: INCB-018424
- Generic name: ruxolitinib phosphate
- Brand names: Jakafi, Jakavi
References
Categories:
- Drugs
- Oral medications
- JAK1 inhibitors
- JAK2 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
- Health Canada approved in 2012
- PMDA approved in 2014