mitomycin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antineoplastics, nucleotoxic agents | 1819 | 50-07-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional ALKYLATING AGENTS causing cross-linking of DNA and inhibition of DNA synthesis.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 24, 1981 | FDA |
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 |
|---|---|---|---|---|---|---|
| Off label use | 106.05 | 31.94 | 101 | 1798 | 379740 | 46304423 |
| Scleral thinning | 105.60 | 31.94 | 13 | 1886 | 22 | 46684141 |
| Conjunctival filtering bleb leak | 95.45 | 31.94 | 11 | 1888 | 6 | 46684157 |
| Haemolytic uraemic syndrome | 80.47 | 31.94 | 19 | 1880 | 2495 | 46681668 |
| Pulmonary veno-occlusive disease | 74.98 | 31.94 | 15 | 1884 | 906 | 46683257 |
| Conjunctival erosion | 66.87 | 31.94 | 8 | 1891 | 9 | 46684154 |
| Mucosal inflammation | 57.07 | 31.94 | 29 | 1870 | 38947 | 46645216 |
| Malignant neoplasm progression | 55.78 | 31.94 | 34 | 1865 | 64892 | 46619271 |
| Leukopenia | 49.19 | 31.94 | 32 | 1867 | 68311 | 46615852 |
| Neutropenia | 49.15 | 31.94 | 43 | 1856 | 143161 | 46541002 |
| Thrombocytopenia | 47.48 | 31.94 | 40 | 1859 | 126541 | 46557622 |
| Bladder perforation | 42.48 | 31.94 | 7 | 1892 | 140 | 46684023 |
| Hypotony of eye | 42.43 | 31.94 | 7 | 1892 | 141 | 46684022 |
| Necrotising scleritis | 41.34 | 31.94 | 7 | 1892 | 166 | 46683997 |
| Iris transillumination defect | 41.06 | 31.94 | 6 | 1893 | 52 | 46684111 |
| Metastases to liver | 38.99 | 31.94 | 18 | 1881 | 19567 | 46664596 |
| Extravasation | 37.67 | 31.94 | 10 | 1889 | 2105 | 46682058 |
| Eye infection toxoplasmal | 37.54 | 31.94 | 7 | 1892 | 291 | 46683872 |
| Disease progression | 36.57 | 31.94 | 30 | 1869 | 91270 | 46592893 |
| Limbal stem cell deficiency | 33.67 | 31.94 | 4 | 1895 | 4 | 46684159 |
| Tractional retinal detachment | 33.57 | 31.94 | 5 | 1894 | 50 | 46684113 |
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 |
|---|---|---|---|---|---|---|
| Off label use | 146.07 | 30.07 | 111 | 1408 | 249179 | 29701780 |
| Conjunctival filtering bleb leak | 84.23 | 30.07 | 10 | 1509 | 6 | 29950953 |
| Scleral thinning | 84.23 | 30.07 | 10 | 1509 | 6 | 29950953 |
| Bladder perforation | 83.52 | 30.07 | 14 | 1505 | 248 | 29950711 |
| Iris hypopigmentation | 51.60 | 30.07 | 7 | 1512 | 25 | 29950934 |
| Conjunctival erosion | 48.71 | 30.07 | 6 | 1513 | 7 | 29950952 |
| Bladder necrosis | 44.46 | 30.07 | 5 | 1514 | 0 | 29950959 |
| Scrotal ulcer | 40.90 | 30.07 | 8 | 1511 | 343 | 29950616 |
| Gastric perforation | 40.26 | 30.07 | 11 | 1508 | 2070 | 29948889 |
| Post embolisation syndrome | 38.70 | 30.07 | 6 | 1513 | 63 | 29950896 |
| Eosinophilic cystitis | 35.50 | 30.07 | 5 | 1514 | 25 | 29950934 |
| Hypotony of eye | 34.67 | 30.07 | 6 | 1513 | 129 | 29950830 |
| Extravasation | 32.30 | 30.07 | 9 | 1510 | 1819 | 29949140 |
| Conjunctival bleb | 31.90 | 30.07 | 4 | 1515 | 6 | 29950953 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01DC03 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES Other cytotoxic antibiotics |
| FDA MoA | N0000000236 | Alkylating Activity |
| FDA EPC | N0000175558 | Alkylating Drug |
| MeSH PA | D000477 | Alkylating Agents |
| MeSH PA | D000903 | Antibiotics, Antineoplastic |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D003432 | Cross-Linking Reagents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D007202 | Indicators and Reagents |
| MeSH PA | D009676 | Noxae |
| MeSH PA | D019384 | Nucleic Acid Synthesis Inhibitors |
| CHEBI has role | CHEBI:35610 | cytostatic |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Adenocarcinoma of pancreas | indication | 700423003 | DOID:4074 |
| Metastatic Gastric Cancer | indication | ||
| Non-small cell lung cancer | off-label use | 254637007 | DOID:3908 |
| Malignant tumor of head and/or neck | off-label use | 255056009 | |
| Malignant tumor of anus | off-label use | 363490009 | DOID:14110 |
| Malignant tumor of urinary bladder | off-label use | 399326009 | DOID:11054 |
| Prevention of Recurrent Bladder Carcinoma | off-label use | ||
| Corneal Conjunctival Intraepithelial Neoplasm | off-label use | ||
| Stomatitis | contraindication | 61170000 | DOID:9637 |
| Acute infectious disease | contraindication | 63171007 | |
| Blood coagulation disorder | contraindication | 64779008 | DOID:1247 |
| Heart failure | contraindication | 84114007 | DOID:6000 |
| Leukopenia | contraindication | 84828003 | DOID:615 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Hemolytic uremic syndrome | contraindication | 111407006 | DOID:12554 |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Pregnancy, function | contraindication | 289908002 | |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Bone marrow depression | contraindication | 307762000 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Pulmonary Infiltrates | contraindication |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.54 | acidic |
| pKa2 | 10.39 | Basic |
| pKa3 | 7.53 | Basic |
| pKa4 | 4.95 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 40MG/VIAL | JELMYTO | UROGEN PHARMA | N211728 | April 15, 2020 | RX | POWDER | PYELOCALYCEAL | April 15, 2023 | NEW PRODUCT |
| 40MG/VIAL | JELMYTO | UROGEN PHARMA | N211728 | April 15, 2020 | RX | POWDER | PYELOCALYCEAL | April 15, 2027 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH LOW-GRADE UPPER TRACT UROTHELIAL CANCER (LG-UTUC) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Indoleamine 2,3-dioxygenase 1 | Enzyme | Ki | 4.60 | CHEMBL | |||||
| DNA | DNA | OTHER | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 4018134 | VUID |
| N0000146471 | NUI |
| D00208 | KEGG_DRUG |
| 4018134 | VANDF |
| C0002475 | UMLSCUI |
| CHEBI:27504 | CHEBI |
| CHEMBL105 | ChEMBL_ID |
| D016685 | MESH_DESCRIPTOR_UI |
| DB00305 | DRUGBANK_ID |
| 7089 | IUPHAR_LIGAND_ID |
| 3043 | INN_ID |
| 50SG953SK6 | UNII |
| 5746 | PUBCHEM_CID |
| 204298 | RXNORM |
| 1274 | MMSL |
| 1973 | MMSL |
| 5122 | MMSL |
| d00305 | MMSL |
| 002660 | NDDF |
| 387331000 | SNOMEDCT_US |
| 59240002 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9279 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 17 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9280 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 17 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-108 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-115 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-116 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-246 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-247 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-248 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-518 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 16 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-519 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 16 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-520 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 16 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-995 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 16 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-996 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 16 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-997 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 16 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-389 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-390 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-391 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 18 sections |
| MUTAMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69448-001 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 18 sections |
| MUTAMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69448-002 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 18 sections |
| MUTAMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69448-003 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 18 sections |