Difference between revisions of "Ponatinib (Iclusig)"
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==General information== | ==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.<ref name="insert">[http://iclusig.com/ | + | 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.<ref name="insert">[http://iclusig.com/pi Ponatinib (Iclusig) package insert]</ref><ref>[[Media:Ponatinib.pdf | Ponatinib (Iclusig) package insert (locally hosted backup)]]</ref><ref>[http://iclusig.com/ Iclusig manufacturer's website]</ref><ref>[http://www.ariad.com/wt/tertiarypage/AP24534 Ariad's Ponatinib (AP24534) site]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| Line 17: | Line 17: | ||
*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. | *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. | *12/20/2013: [http://www.iclusigrems.com/ REMS] program put in place and medication is once again available. | ||
| + | *11/29/2016: FDA granted full approval "for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase [[Chronic myelogenous leukemia | chronic myeloid leukemia (CML)]] or Philadelphia chromosome–positive [[Acute lymphocytic leukemia | acute lymphoblastic leukemia (ALL)]] for whom no other tyrosine kinase inhibitor therapy is indicated; and for the treatment of adult patients with T315I–positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive, Philadelphia chromosome–positive ALL." | ||
==Also known as== | ==Also known as== | ||
Revision as of 02:00, 30 November 2016
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
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.
- 12/20/2013: REMS program put in place and medication is once again available.
- 11/29/2016: FDA 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; and for the treatment of adult patients with T315I–positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive, Philadelphia chromosome–positive ALL."
Also known as
AP24534