Difference between revisions of "Cytarabine and daunorubicin liposomal (Vyxeos)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*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. ''(Based on CLTR0310-301)'' | *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. ''(Based on CLTR0310-301)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *8/23/2018: 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== | ||
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[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
| + | [[Category:EMA approved in 2018]] | ||
Revision as of 13:32, 31 December 2022
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 used
History of changes in FDA indication
- 8/3/2017: 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
- 8/23/2018: Initial authorization
Patient Information
Also known as
- Code name: CPX-351
- Brand name: Vyxeos, Vyxeos liposomal