Difference between revisions of "Ponatinib (Iclusig)"

Revision as of 21:09, 24 January 2014

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.
12/20/2013: REMS program put in place and medication is once again available.

Also known as

AP24534

References

[insert-1] 1.0 ^1.1 ^1.2 Ponatinib (Iclusig) package insert

[2] Ponatinib (Iclusig) package insert (locally hosted backup)

[3] Iclusig manufacturer's website

[4] Ariad's Ponatinib (AP24534) site

[1]

[2]

[3]

[4]

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-'''[http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm373072.htm 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 [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm107434.htm?et_cid=32739085&et_rid=582674302&linkid=http%3a%2f%2fwww.fda.gov%2fDrugs%2fDevelopmentApprovalProcess%2fHowDrugsareDevelopedandApproved%2fApprovalApplications%2fInvestigationalNewDrugINDApplication%2fucm107434.htm+ 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.<ref name="insert">[http://iclusig.com/pdf/FDA_Approved_PI.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>