Difference between revisions of "Cytarabine and daunorubicin liposomal (Vyxeos)"
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==Mechanism of action== | ==Mechanism of action== | ||
| − | 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>[[ | + | 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> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
| − | ==Disease for which it is | + | ==Disease for which it is established== |
*[[Acute myeloid leukemia]] | *[[Acute myeloid leukemia]] | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *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)'' |
| − | + | ==History of changes in EMA indication== | |
| + | *2018-08-23: Initial authorization | ||
==Patient Information== | ==Patient Information== | ||
*[http://pp.jazzpharma.com/pi/vyxeos.en.USPI.pdf Cytarabine and daunorubicin liposomal (Vyxeos) package insert]<ref name="insert"></ref> | *[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== | ==Also known as== | ||
*'''Code name:''' CPX-351 | *'''Code name:''' CPX-351 | ||
| − | *'''Brand name:''' Vyxeos | + | *'''Brand name:''' Vyxeos, Vyxeos liposomal |
==References== | ==References== | ||
| Line 21: | Line 22: | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
| + | [[Category:Combination drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
[[Category:Liposomal chemotherapy]] | [[Category:Liposomal chemotherapy]] | ||
| Line 26: | Line 28: | ||
[[Category:Anthracyclines]] | [[Category:Anthracyclines]] | ||
[[Category:Antimetabolites]] | [[Category:Antimetabolites]] | ||
| − | [[Category:Deoxycytidine | + | [[Category:Deoxycytidine analogs]] |
| − | [[Category:Topoisomerase inhibitors]] | + | [[Category:Topoisomerase II inhibitors]] |
[[Category:Acute myeloid leukemia medications]] | [[Category:Acute myeloid leukemia medications]] | ||
[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
| + | [[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
- 2017-08-03: Granted FDA regular approval for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis. (Based on CLTR0310-301)
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