Ponatinib (Iclusig)

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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

  • 2013-10-31: Suspended by FDA because of the risk of life-threatening blood clots and severe narrowing of blood vessels.
  • 2013-12-20: REMS program put in place and medication is once again available; REMS was discontinued in August 2018.

Diseases for which it is used

Patient drug information

History of changes in FDA indication

History of changes in EMA indication

  • 2013-07-01: Initial authorization

History of changes in Health Canada indication

  • 2015-04-02: Initial notice of compliance with conditions
  • 2022-10-03: Conditions were met

History of changes in PMDA indication

Also known as

  • Code name: AP-24534
  • Generic name: ponatinib hydrochloride
  • Brand name: Iclusig