omacetaxine mepesuccinate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4677 | 26833-87-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Semisynthetic derivative of harringtonine that acts as a protein synthesis inhibitor and induces APOPTOSIS in tumor cells. It is used in the treatment of MYELOID LEUKEMIA, CHRONIC.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 1.80 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 2.96 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 9.80 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 26, 2012 | FDA | IVAX INTL |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Bone marrow failure | 70.83 | 43.14 | 21 | 571 | 29269 | 63459161 |
| Platelet count decreased | 64.78 | 43.14 | 28 | 564 | 116094 | 63372336 |
| Myelosuppression | 61.69 | 43.14 | 18 | 574 | 23685 | 63464745 |
| Injection site erythema | 49.40 | 43.14 | 21 | 571 | 83153 | 63405277 |
| Nausea | 47.57 | 43.14 | 48 | 544 | 854423 | 62634007 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Myelosuppression | 90.23 | 46.46 | 26 | 533 | 19239 | 34937133 |
| Injection site erythema | 54.95 | 46.46 | 17 | 542 | 15882 | 34940490 |
| Platelet count decreased | 46.94 | 46.46 | 27 | 532 | 119690 | 34836682 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Myelosuppression | 145.11 | 42.37 | 42 | 956 | 40254 | 79703136 |
| Platelet count decreased | 86.64 | 42.37 | 44 | 954 | 194620 | 79548770 |
| Nausea | 80.44 | 42.37 | 77 | 921 | 957119 | 78786271 |
| Bone marrow failure | 78.83 | 42.37 | 28 | 970 | 51079 | 79692311 |
| Injection site erythema | 54.04 | 42.37 | 24 | 974 | 78173 | 79665217 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XX40 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D000972 | Antineoplastic Agents, Phytogenic |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D011500 | Protein Synthesis Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agents |
| CHEBI has role | CHEBI:48001 | protein synthesis inhibitors |
| CHEBI has role | CHEBI:68495 | Type I cell-death inducers |
| CHEBI has role | CHEBI:149553 | anticoronaviral drug |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic myeloid leukemia | indication | 92818009 | DOID:8552 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 12.86 | acidic |
| pKa2 | 8.15 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 3.5MG/VIAL | SYNRIBO | TEVA PHARMS INTL | N203585 | Oct. 26, 2012 | RX | POWDER | SUBCUTANEOUS | 6987103 | Oct. 26, 2026 | TREATMENT OF PATIENTS WITH TYROSINE KINASE INHIBITOR (TKI) RESISTANT OR INTOLERANT CHRONIC MYELOID/MYELOGENOUS LEUKEMIA (CML) |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| D08956 | KEGG_DRUG |
| 4031782 | VUID |
| N0000186058 | NUI |
| 4031782 | VANDF |
| 4031814 | VANDF |
| CHEBI:71019 | CHEBI |
| HMT | PDB_CHEM_ID |
| CHEMBL46286 | ChEMBL_ID |
| 7454 | IUPHAR_LIGAND_ID |
| 8885 | INN_ID |
| DB04865 | DRUGBANK_ID |
| 6FG8041S5B | UNII |
| 1356689 | RXNORM |
| 194347 | MMSL |
| 27023 | MMSL |
| d07573 | MMSL |
| 009753 | NDDF |
| 421021001 | SNOMEDCT_US |
| 421815001 | SNOMEDCT_US |
| C0062941 | UMLSCUI |
| D000077863 | MESH_DESCRIPTOR_UI |
| C3528000 | UMLSCUI |
| 285033 | PUBCHEM_CID |
| 24316-19-6 | SECONDARY_CAS_RN |
| 65305 | PUBCHEM_CID |
| 84MI6OYN4Z | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| SYNRIBO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63459-177 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 3.50 mg | SUBCUTANEOUS | NDA | 27 sections |
| SYNRIBO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63459-177 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 3.50 mg | SUBCUTANEOUS | NDA | 27 sections |