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">[ | + | 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">[https://www.iclusig.com/pdf/ICLUSIG-Prescribing-Information.pdf 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 14: | Line 14: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *12/14/2012: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332252.htm FDA approved] for the treatment of adult patients with chronic phase, accelerated phase, or blast phase [[Chronic myelogenous leukemia|chronic myeloid leukemia (CML)]] that is resistant or intolerant to prior [[Regimen_classes#Tyrosine_kinase_inhibitor_therapy|tyrosine kinase inhibitor therapy]] | + | *12/14/2012: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332252.htm FDA approved] for the treatment of adult patients with chronic phase, accelerated phase, or blast phase [[Chronic myelogenous leukemia|chronic myeloid leukemia (CML)]] that is resistant or intolerant to prior [[Regimen_classes#Tyrosine_kinase_inhibitor_therapy|tyrosine kinase inhibitor therapy]] ''(Based on OPTIC)'' |
| − | *12/14/2012: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332252.htm FDA approved] for the treatment of adult patients with [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive]] [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] (Ph+ ALL) that is resistant or intolerant to prior [[Regimen_classes#Tyrosine_kinase_inhibitor_therapy|tyrosine kinase inhibitor therapy]]. | + | *12/14/2012: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332252.htm FDA approved] for the treatment of adult patients with [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive]] [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] (Ph+ ALL) that is resistant or intolerant to prior [[Regimen_classes#Tyrosine_kinase_inhibitor_therapy|tyrosine kinase inhibitor therapy]]. ''(Based on PACE)'' |
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*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 [[Biomarkers#BCR-ABL1|Philadelphia chromosome–positive]] [[:Category:Acute lymphoblastic leukemias| acute lymphoblastic leukemia (ALL)]] for whom no other tyrosine kinase inhibitor therapy is indicated | *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 [[Biomarkers#BCR-ABL1|Philadelphia chromosome–positive]] [[:Category:Acute lymphoblastic leukemias| acute lymphoblastic leukemia (ALL)]] for whom no other tyrosine kinase inhibitor therapy is indicated | ||
*11/29/2016: FDA 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) | *11/29/2016: FDA 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) | ||
*11/29/2016: FDA 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]]. | *11/29/2016: FDA 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]]. | ||
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| + | ==REMS program== | ||
| + | *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. | ||
==Also known as== | ==Also known as== | ||
Revision as of 18:51, 2 May 2021
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 (Based on OPTIC)
- 12/14/2012: FDA approved 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: 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
- 11/29/2016: FDA granted full approval for the treatment of adult patients with T315I–positive CML (chronic phase, accelerated phase, or blast phase)
- 11/29/2016: FDA granted full approval for the treatment of adult patients with T315I-positive, Philadelphia chromosome–positive ALL.
REMS program
- 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.
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 myelogenous leukemia medications
- REMS program
- FDA approved in 2012
- PMDA approved drugs