Difference between revisions of "Ponatinib (Iclusig)"
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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> | 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> | ||
| + | ==Toxicity management== | ||
| + | *10/31/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm373072.htm Suspended by FDA] because of the risk of life-threatening blood clots and severe narrowing of blood vessels. | ||
| + | *12/20/2013: [http://www.iclusigrems.com/ REMS] program put in place and medication is once again available. | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
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*11/29/2016: Granted full approval for the treatment of adult patients with [[Biomarkers#T315I|T315I]]–positive [[chronic myelogenous leukemia|CML]] (chronic phase, accelerated phase, or blast phase). ''(Based on PACE)'' | *11/29/2016: Granted full approval for the treatment of adult patients with [[Biomarkers#T315I|T315I]]–positive [[chronic myelogenous leukemia|CML]] (chronic phase, accelerated phase, or blast phase). ''(Based on PACE)'' | ||
*11/29/2016: Granted full approval for the treatment of adult patients with [[Biomarkers#T315I|T315I]]-positive, [[Biomarkers#BCR-ABL1|Philadelphia chromosome–positive]] [[:Category:Acute lymphoblastic leukemias|ALL]]. ''(Based on PACE)'' | *11/29/2016: Granted full approval for the treatment of adult patients with [[Biomarkers#T315I|T315I]]-positive, [[Biomarkers#BCR-ABL1|Philadelphia chromosome–positive]] [[:Category:Acute lymphoblastic leukemias|ALL]]. ''(Based on PACE)'' | ||
| − | + | ==History of changes in EMA indication== | |
| − | == | + | *7/1/2013: Initial authorization |
| − | * | ||
| − | |||
| − | |||
==Also known as== | ==Also known as== | ||
*'''Code name:''' AP24534 | *'''Code name:''' AP24534 | ||
Revision as of 13:53, 31 December 2022
General information
Class/mechanism: Tyrosine kinase inhibitor with multiple targets, including Bcr-Abl tyrosine kinase, the constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality in CML, as well as VEGFR, PDGFR, FGFR, the SRC kinases, KIT, EPH receptors, RET, TIE2, and FLT3. Ponatinib is active against the Bcr-Abl T315I mutation.[1][2][3]
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]
Toxicity management
- 10/31/2013: Suspended by FDA because of the risk of life-threatening blood clots and severe narrowing of blood vessels.
- 12/20/2013: REMS program put in place and medication is once again available.
Diseases for which it is used
Patient drug information
- Ponatinib (Iclusig) package insert[1]
- Ponatinib (Iclusig) patient drug information (Chemocare)[4]
- Ponatinib (Iclusig) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 12/14/2012: Accelerated approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy (Based on OPTIC)
- 12/14/2012: Accelerated approval for the treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. (Based on PACE)
- 11/29/2016: Granted full approval for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) for whom no other tyrosine kinase inhibitor therapy is indicated. (Based on PACE)
- 11/29/2016: Granted full approval for the treatment of adult patients with T315I–positive CML (chronic phase, accelerated phase, or blast phase). (Based on PACE)
- 11/29/2016: Granted full approval for the treatment of adult patients with T315I-positive, Philadelphia chromosome–positive ALL. (Based on PACE)
History of changes in EMA indication
- 7/1/2013: Initial authorization
Also known as
- Code name: AP24534
- Generic name: ponatinib hydrochloride
- Brand name: Iclusig
References
Categories:
- Drugs
- Oral medications
- Mutation-specific medications
- Bcr-Abl inhibitors
- FGFR inhibitors
- FLT3 inhibitors
- KIT inhibitors
- RET inhibitors
- SRC inhibitors
- VEGFR inhibitors
- PDGFR inhibitors
- B-cell acute lymphoblastic leukemia medications
- Chronic myeloid leukemia medications
- REMS program
- FDA approved in 2012
- EMA approved in 2013
- PMDA approved drugs