Difference between revisions of "Ponatinib (Iclusig)"
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[[Category:Kinase inhibitors]] | [[Category:Kinase inhibitors]] | ||
[[Category:Bcr-Abl inhibitors]] | [[Category:Bcr-Abl inhibitors]] | ||
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[[Category:VEGF inhibitors]] | [[Category:VEGF inhibitors]] | ||
[[Category:PDGFR inhibitors]] | [[Category:PDGFR inhibitors]] | ||
[[Category:Chronic myelogenous leukemia medications]] | [[Category:Chronic myelogenous leukemia medications]] | ||
[[Category:Drugs FDA approved in 2012]] | [[Category:Drugs FDA approved in 2012]] | ||
Revision as of 19:28, 8 January 2014
Suspended by FDA on 10/31/13 because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Patients who are currently taking Iclusig and responding to the drug and whose health care professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA's safety investigation continues. For more information on obtaining access to treatment for your patient under an IND, please refer to this website.
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][4]
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]
Diseases for which it is used
- Chronic myelogenous leukemia
- Philadelphia chromosome positive acute lymphocytic leukemia
Patient drug information
- Patient counseling information can be found on pages 16-17 of the Ponatinib (Iclusig) package insert[1]
History of changes in FDA indication
- 12/14/2012: FDA approved "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 or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy."
- 10/31/2013: Suspended by FDA because of the risk of life-threatening blood clots and severe narrowing of blood vessels.
Also known as
AP24534