Difference between revisions of "Ruxolitinib (Jakafi)"

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

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

[insert-1] 1.0 ^1.1 ^1.2 Ruxolitinib (Jakafi) package insert

[2] Ruxolitinib (Jakafi) package insert (locally hosted backup)

[3] Jakafi manufacturer's website

[4] Ruxolitinib (Jakafi) patient drug information (Chemocare)

[5] Ruxolitinib (Jakafi) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

[5]

@@ Line 1: / Line 1: @@
 ==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.<ref name="insert">[http://www.incyte.com/products/uspi_jakafi.pdf Ruxolitinib (Jakafi) package insert]</ref><ref>[[Media:Ruxolitinib.pdf | Ruxolitinib (Jakafi) package insert (locally hosted backup)]]</ref>
+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.<ref name="insert">[https://www.jakafi.com/pdf/prescribing-information.pdf Ruxolitinib (Jakafi) package insert]</ref><ref>[[:File:Ruxolitinib.pdf | Ruxolitinib (Jakafi) package insert (locally hosted backup)]]</ref>
 <br>Route: PO
 <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 [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 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 used==
+==Diseases for which it is established==
+*[[Graft versus host disease]]
 *[[Myelofibrosis]]
 *[[Polycythemia vera]]
+==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 [http://www.incyte.com/products/uspi_jakafi.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/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>
 ==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]], including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.
+* 2011-11-16: [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]]. ''(Based on COMFORT-I and COMFORT-II)''
-* 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)]]."
+* 2014-12-04: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425677.htm 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)]]. ''(New disease entity; based on RESPONSE)''
+* 2019-05-24: Indication expanded for steroid-refractory acute [[Graft_versus_host_disease|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|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==
-INCB018424.
+*'''Code name:''' INCB-018424
+*'''Generic name:''' ruxolitinib phosphate
+*'''Brand names:''' Jakafi, Jakavi
 ==References==
 <references/>
-[[Category:Drug index]]
+[[Category:Drugs]]
-[[Category:Chemotherapy]]
+[[Category:Oral medications]]
-[[Category:Oral chemotherapy]]
-[[Category:Kinase inhibitors]]
+[[Category:JAK1 inhibitors]]
-[[Category:JAK inhibitors]]
+[[Category:JAK2 inhibitors]]
+[[Category:Acute myeloid leukemia medications]]
+[[Category:Chronic lymphocytic leukemia medications]]
+[[Category:Graft versus host disease medications]]
+[[Category:Essential thrombocythemia medications]]
+[[Category:Hypereosinophilic syndrome medications]]
 [[Category:Myelofibrosis medications]]
 [[Category:Polycythemia vera medications]]
-[[Category:Drugs FDA approved in 2011]]
+[[Category:FDA approved in 2011]]
+[[Category:EMA approved in 2012]]
+[[Category:Health Canada approved in 2012]]
+[[Category:PMDA approved in 2014]]