Difference between revisions of "Bosutinib (Bosulif)"
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m (PeterYang moved page Bosutinib (SKI-606) to Bosutinib (Bosulif): FDA approval) |
(FDA approval) |
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| − | ''' | + | '''FDA approved 9/4/2012.''' Also known as SKI-606. |
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==General information== | ==General information== | ||
| − | Class/mechanism: Third-generation tyrosine kinase inhibitor, | + | Class/mechanism: Third-generation tyrosine kinase inhibitor of Bcr-Abl, the constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality in CML. Also inhibits kinases in the Src family, including Src, Lyn, and Hck. Active against many imatinib-resistant mutations (16 of 18 imatinib-resistant forms of Bcr-Abl in murine myeloid cell lines), but not active against the T315I and V299L mutations.<ref name=insert>[http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203341lbl.pdf Bosutinib (Bosulif) package insert]</ref><ref>[[Media:Bosutinib.pdf | Bosutinib (Bosulif) package insert (locally hosted backup)]]</ref><ref>[http://www.ascopost.com/issues/february-15-2012-supplement/bela-trial-reborn-bosutinib-produces-improved-results-in-chronic-myeloid-leukemia.aspx ASCO Post 2/15/2012: BELA Trial Reborn: Bosutinib Produces Improved Results in Chronic Myeloid Leukemia]</ref> |
<br>Route: Oral | <br>Route: Oral | ||
<br>Extravasation: n/a | <br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the package insert. | + | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the package insert.<ref name=insert></ref> |
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| + | ==Diseases for which it is used== | ||
| + | *[[Chronic myelogenous leukemia | Chronic myelogenous leukemia (CML)]] | ||
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| + | ==Clinical trials== | ||
| + | *BELA: [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=114&abstractID=100550 Bosutinib (BOS) versus imatinib (IM) in patients (pts) with newly diagnosed chronic phase chronic myeloid leukemia (CP CML)] | ||
| + | *[http://clinicaltrials.gov/ct2/show/NCT00261846 Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias] | ||
| + | *[http://clinicaltrials.gov/ct2/show/NCT00574873 Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML] | ||
| + | |||
==Patient drug information== | ==Patient drug information== | ||
| − | + | *Brief patient counseling information can be found on pages 12-13 of the [http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203341lbl.pdf#page=12 Bosutinib (Bosulif) package insert]<ref name=insert></ref> | |
==References== | ==References== | ||
<references/> | <references/> | ||
Revision as of 06:02, 5 September 2012
FDA approved 9/4/2012. Also known as SKI-606.
General information
Class/mechanism: Third-generation tyrosine kinase inhibitor of Bcr-Abl, the constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality in CML. Also inhibits kinases in the Src family, including Src, Lyn, and Hck. Active against many imatinib-resistant mutations (16 of 18 imatinib-resistant forms of Bcr-Abl in murine myeloid cell lines), but not active against the T315I and V299L mutations.[1][2][3]
Route: Oral
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 package insert.[1]
Diseases for which it is used
Clinical trials
- BELA: Bosutinib (BOS) versus imatinib (IM) in patients (pts) with newly diagnosed chronic phase chronic myeloid leukemia (CP CML)
- Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
- Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
Patient drug information
- Brief patient counseling information can be found on pages 12-13 of the Bosutinib (Bosulif) package insert[1]