Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Omacetaxine mepesuccinate
Drug ID BADD_D01609
Description Omacetaxine mepesuccinate (formerly known as HHT or Homoharringtonine), is a cephalotaxine ester and protein synthesis inhibitor with established clinical activity as a single agent in hematological malignancies. Omacetaxine mepesuccinate is synthesized from cephalotaxine, which is an extract from the leaves of the plant, Cephalotaxus species. In October 2005, omacetaxine mepesuccinate received Orphan Drug designation from the EMEA for the treatment of chronic myeloid leukemia (CML). Then in March 2006, it received Orphan Drug status from the FDA for the treatment of CML. In November 2006, omacetaxine mepesuccinate, for the treatment of CML, was granted Fast Track designation by the FDA. Most recently, in October 2012, omacetaxine mepesuccinate was marketed under the brand name Synribo and FDA approved for patients who are intolerant and/or resistant to two or more tyrosine kinase inhibitors used to treat accelerated or chronic phase CML.
Indications and Usage Used in patients who are intolerant and/or resistant to two or more tyrosine kinase inhibitors used to treat accelerated or chronic phase CML.
Marketing Status approved; investigational
ATC Code L01XX40
DrugBank ID DB04865
KEGG ID D08956
MeSH ID D000077863
PubChem ID 285033
TTD Drug ID D0M4XY
NDC Product Code 63459-177; 69605-732
UNII 6FG8041S5B
Synonyms Homoharringtonine | Omacetaxine Mepesuccinate | Cephalotaxine | Omacetaxine | Homoharringtonine (3(R))-isomer | Ceflatonin | Synribo
Chemical Information
Molecular Formula C29H39NO9
CAS Registry Number 26833-87-4
SMILES CC(C)(CCCC(CC(=O)OC)(C(=O)OC1C2C3=CC4=C(C=C3CCN5C2(CCC5)C=C1OC)OCO4)O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
White blood cell count decreased13.01.06.012--
Mental status changes19.07.01.001---
Peripheral swelling02.05.04.015; 08.01.03.0530.000381%-
Contusion12.01.06.001; 15.03.05.007; 23.03.11.002; 24.07.06.001--
Musculoskeletal chest pain15.03.04.012; 22.09.01.001--
Acute coronary syndrome02.02.02.015; 24.04.04.011---
Infusion related reaction08.01.03.002; 10.01.01.017; 12.02.05.009--
Catheter site pain08.02.02.004; 12.07.02.004---
Musculoskeletal stiffness15.03.05.027---
Musculoskeletal discomfort15.03.04.001---
Transaminases increased13.03.04.036---
Haemorrhage24.07.01.002---
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.005--
Adverse event08.06.01.0100.000168%-
Decreased appetite08.01.09.028; 14.03.01.0050.000302%
Disease progression08.01.03.0380.000795%
Drug intolerance08.06.01.0130.000761%-
Bone marrow failure01.03.03.0050.000280%
Treatment failure08.06.01.0170.000627%-
Cardiac failure chronic02.05.01.0090.000112%-
Blast crisis in myelogenous leukaemia01.10.08.002; 16.01.08.0020.000112%-
Cardiorenal syndrome02.05.01.012; 20.01.03.0180.000112%-
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.000246%-
Myelosuppression01.03.03.0150.000112%-
Therapy non-responder08.06.01.0630.000571%-
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