Difference between revisions of "Omacetaxine (Synribo)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *10/26/2012: | + | *10/26/2012: Accelerated approval for treatment of adult patients with chronic or accelerated phase [[Chronic myelogenous leukemia|chronic myeloid leukemia (CML)]] with resistance and/or intolerance to two or more [[Regimen_classes#Tyrosine_kinase_inhibitor_therapy|tyrosine kinase inhibitors (TKI)]]. ''(Based on CGX-635-CML-202 and CGX-635-CML-203)'' |
| + | **2/10/2014: Converted to regular approval. | ||
==Also known as== | ==Also known as== | ||
Revision as of 01:11, 11 December 2021
General information
Class/mechanism: Cephalotaxine ester & natural alkaloid that inhibits protein synthesis/translation/elongation; prepared via a semi-synthetic process from cephalotaxine, an extract of Cephalotaxus species leaves. Mechanism is not fully understood, but omacetaxine mepesuccinate inhibits protein synthesis and promotes apoptosis in a manner that does not involve direct binding of Bcr-Abl. Omacetaxine mepesuccinate has been observed to bind to the A-site cleft in the large ribosomal subunit of a type of archaeabacteria. It reduces levels of Bcr-Abl and human induced myeloid leukemia cell differentiation protein Mcl-1, an anti-apoptotic Bcl-2 family member. Omacetaxine mepesuccinate has been seen to have activity in mouse models with wild-type Bcr-Abl, as well as imatinib-resistant chronic myeloid leukemia (CML) models with the T315I mutation.[1][2][3][4]
Route: IV, SC
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Brief patient counseling information can be found on page 10 of the Omacetaxine mepesuccinate (Synribo) package insert[1]
History of changes in FDA indication
- 10/26/2012: Accelerated approval for treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI). (Based on CGX-635-CML-202 and CGX-635-CML-203)
- 2/10/2014: Converted to regular approval.
Also known as
- Generic names: HHT, homoharringtonine, omacetaxine mepesuccinate
- Brand names: Omapro, Synribo
References
- ↑ 1.0 1.1 1.2 Omacetaxine mepesuccinate (Synribo) package insert
- ↑ Omacetaxine mepesuccinate (Synribo) package insert (locally hosted backup)
- ↑ Synribo manufacturer's website
- ↑ Quintás-Cardama A, Kantarjian H, Cortes J. Homoharringtonine, omacetaxine mepesuccinate, and chronic myeloid leukemia circa 2009. Cancer. 2009 Dec 1;115(23):5382-93. link to original article PubMed