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.
Route: IV, SC
Extravasation: no information
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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
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
- 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