Difference between revisions of "Cytarabine and daunorubicin liposomal (Vyxeos)"
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<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== | ==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> | ||
Revision as of 11:06, 8 May 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