Difference between revisions of "Cytarabine and daunorubicin liposomal (Vyxeos)"

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==Mechanism of action==
 
==Mechanism of action==
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This drug is a liposomal formulation of [[Cytarabine (Cytosar)]] and [[Daunorubicin (Cerubidine)]] in a 5:1 molar ratio.
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This drug is a liposomal formulation of [[Cytarabine (Ara-C)]] and [[Daunorubicin (Cerubidine)]] in a 5:1 molar ratio. <ref name="insert">[http://pp.jazzpharma.com/pi/vyxeos.en.USPI.pdf Cytarabine and daunorubicin liposomal (Vyxeos) package insert]</ref><ref>[[:File:Daunorubicincytarabineliposomal.pdf | Cytarabine and daunorubicin liposomal (Vyxeos) package insert (locally hosted backup)]]</ref><ref>[https://vyxeos.com/ Vyxeos manufacturer's website]</ref>
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<br>Route: IV
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<br>Extravasation: no information
  
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==Preliminary data==
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==Disease for which it is established==
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<!-- Presented in part in abstract form at the 52nd annual meeting of the American Society of Hematology, Orlando, FL December 4-7, 2010. -->
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*[[Acute myeloid leukemia]]
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# Lancet JE, Cortes JE, Hogge DE, Tallman MS, Kovacsovics TJ, Damon LE, Komrokji R, Solomon SR, Kolitz JE, Cooper M, Yeager AM, Louie AC, Feldman EJ. Phase 2 trial of CPX-351, a fixed 5:1 molar ratio of cytarabine/daunorubicin, vs cytarabine/daunorubicin in older adults with untreated AML. Blood. 2014 May 22;123(21):3239-46. Epub 2014 Mar 31. [http://bloodjournal.hematologylibrary.org/content/123/21/3239.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/24687088 PubMed]
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==History of changes in FDA indication==
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*2017-08-03: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm569950.htm Granted FDA regular approval] for the treatment of adults with newly-diagnosed [[Acute myeloid leukemia|therapy-related AML (t-AML)]] or [[Acute myeloid leukemia|AML with myelodysplasia-related changes (AML-MRC)]], two types of AML having a poor prognosis. ''(Based on CLTR0310-301)''
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==History of changes in EMA indication==
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*2018-08-23: Initial authorization
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==Patient Information==
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*[http://pp.jazzpharma.com/pi/vyxeos.en.USPI.pdf Cytarabine and daunorubicin liposomal (Vyxeos) package insert]<ref name="insert"></ref>
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==Also known as==
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*'''Code name:''' CPX-351
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*'''Brand name:''' Vyxeos, Vyxeos liposomal
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==References==
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<references/>
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[[Category:Drugs]]
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[[Category:Combination drugs]]
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[[Category:Intravenous medications]]
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[[Category:Liposomal chemotherapy]]
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[[Category:Anthracyclines]]
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[[Category:Antimetabolites]]
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[[Category:Deoxycytidine analogs]]
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[[Category:Topoisomerase II inhibitors]]
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[[Category:Acute myeloid leukemia medications]]
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[[Category:FDA approved in 2017]]
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[[Category:EMA approved in 2018]]

Latest revision as of 13:34, 23 September 2023

Mechanism of action

This drug is a liposomal formulation of Cytarabine (Ara-C) and Daunorubicin (Cerubidine) in a 5:1 molar ratio. [1][2][3]
Route: IV
Extravasation: no information

Disease for which it is established

History of changes in FDA indication

History of changes in EMA indication

  • 2018-08-23: Initial authorization

Patient Information

Also known as

  • Code name: CPX-351
  • Brand name: Vyxeos, Vyxeos liposomal

References

  1. ↑ 1.0 1.1 Cytarabine and daunorubicin liposomal (Vyxeos) package insert
  2. ↑ Cytarabine and daunorubicin liposomal (Vyxeos) package insert (locally hosted backup)
  3. ↑ Vyxeos manufacturer's website
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