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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==Disease for which it is used==
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==Disease for which it is established==
 
*[[Acute myeloid leukemia]]
 
*[[Acute myeloid leukemia]]
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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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# 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] [https://www.ncbi.nlm.nih.gov/pubmed/24687088 PubMed]
 
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# Cortes JE, Goldberg SL, Feldman EJ, Rizzeri DA, Hogge DE, Larson M, Pigneux A, Recher C, Schiller G, Warzocha K, Kantarjian H, Louie AC, Kolitz JE. Phase II, multicenter, randomized trial of CPX-351 (cytarabine:daunorubicin) liposome injection versus intensive salvage therapy in adults with first relapse AML. Cancer. 2015 Jan 15;121(2):234-42. Epub 2014 Sep 15. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.28974/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/25223583 PubMed]
 
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
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*8/3/2017: [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."
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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>
  
 
==Also known as==
 
==Also known as==
 
*'''Code name:''' CPX-351
 
*'''Code name:''' CPX-351
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*'''Brand name:''' Vyxeos
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*'''Brand name:''' Vyxeos, Vyxeos liposomal
  
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[[Category:Drug index]]
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==References==
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<references/>
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[[Category:Drugs]]
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[[Category:Combination drugs]]
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
 
[[Category:Liposomal chemotherapy]]
 
[[Category:Liposomal chemotherapy]]
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[[Category:Anthracyclines]]
 
[[Category:Anthracyclines]]
 
[[Category:Antimetabolites]]
 
[[Category:Antimetabolites]]
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[[Category:Deoxycytidine analogues]]
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[[Category:Deoxycytidine analogs]]
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[[Category:Topoisomerase inhibitors]]
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[[Category:Topoisomerase II inhibitors]]
  
 
[[Category:Acute myeloid leukemia medications]]
 
[[Category:Acute myeloid leukemia medications]]
  
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[[Category:Drugs FDA approved in 2017]]
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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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