Difference between revisions of "Omacetaxine (Synribo)"
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==General information== | ==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.<ref name="insert">[https://www.synribohcp.com/globalassets/synribo-hcp/downloadable-assets/synribo_pi.pdf Omacetaxine mepesuccinate (Synribo) package insert]</ref><ref>[[:File:Omacetaxine.pdf | Omacetaxine mepesuccinate (Synribo) package insert (locally hosted backup)]]</ref><ref>[http://synribo.com/ Synribo manufacturer's website]</ref><ref>Quintás-Cardama A, Kantarjian H, Cortes J. Homoharringtonine, omacetaxine mepesuccinate, and chronic myeloid leukemia circa 2009. Cancer. 2009 Dec 1;115(23):5382-93. [https:// | + | 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.<ref name="insert">[https://www.synribohcp.com/globalassets/synribo-hcp/downloadable-assets/synribo_pi.pdf Omacetaxine mepesuccinate (Synribo) package insert]</ref><ref>[[:File:Omacetaxine.pdf | Omacetaxine mepesuccinate (Synribo) package insert (locally hosted backup)]]</ref><ref>[http://synribo.com/ Synribo manufacturer's website]</ref><ref>Quintás-Cardama A, Kantarjian H, Cortes J. Homoharringtonine, omacetaxine mepesuccinate, and chronic myeloid leukemia circa 2009. Cancer. 2009 Dec 1;115(23):5382-93. [https://doi.org/10.1002/cncr.24601 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19739234/ PubMed]</ref> |
Route: IV, SC | Route: IV, SC | ||
<br>Extravasation: no information | <br>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 | + | 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, or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Acute myeloid leukemia]] | *[[Acute myeloid leukemia]] | ||
| − | *[[Chronic | + | *[[Chronic myeloid leukemia]] |
==Patient drug information== | ==Patient drug information== | ||
*[https://www.synribohcp.com/globalassets/synribo-hcp/downloadable-assets/synribo_pi.pdf Omacetaxine (Synribo) package insert]<ref name="insert"></ref> | *[https://www.synribohcp.com/globalassets/synribo-hcp/downloadable-assets/synribo_pi.pdf Omacetaxine (Synribo) package insert]<ref name="insert"></ref> | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/omacetaxine.aspx Omacetaxine (Synribo) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/omacetaxine.aspx Omacetaxine (Synribo) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/omacetaxine-patient-drug-information Omacetaxine (Synribo) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/omacetaxine-patient-drug-information Omacetaxine (Synribo) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/omacetaxine-patient-drug-information Omacetaxine (Synribo) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/omacetaxine-patient-drug-information Omacetaxine (Synribo) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *10 | + | *2012-10-26: Accelerated approval for treatment of adult patients with chronic or accelerated phase [[Chronic myeloid 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)'' |
| − | ** | + | **2014-02-10: Converted to regular approval for treatment of adult patients with chronic or accelerated phase [[Chronic myeloid 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)'' |
==Also known as== | ==Also known as== | ||
| Line 35: | Line 35: | ||
[[Category:Acute myeloid leukemia medications]] | [[Category:Acute myeloid leukemia medications]] | ||
| − | [[Category:Chronic | + | [[Category:Chronic myeloid leukemia medications]] |
[[Category:FDA approved in 2012]] | [[Category:FDA approved in 2012]] | ||
Latest revision as of 00:06, 6 July 2024
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, or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Omacetaxine (Synribo) package insert[1]
- Omacetaxine (Synribo) patient drug information (Chemocare)[5]
- Omacetaxine (Synribo) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 2012-10-26: 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)
- 2014-02-10: Converted to regular 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)
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
- ↑ Omacetaxine (Synribo) patient drug information (Chemocare)
- ↑ Omacetaxine (Synribo) patient drug information (UpToDate)