mitomycin 🐶 Veterinary Use | 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 | 102.63 | 30.97 | 109 | 1914 | 474317 | 50128784 |
| Conjunctival filtering bleb leak | 95.64 | 30.97 | 11 | 2012 | 6 | 50603095 |
| Haemolytic uraemic syndrome | 82.31 | 30.97 | 19 | 2004 | 2300 | 50600801 |
| Pulmonary veno-occlusive disease | 80.38 | 30.97 | 16 | 2007 | 959 | 50602142 |
| Malignant neoplasm progression | 57.36 | 30.97 | 35 | 1988 | 68089 | 50535012 |
| Scleral thinning | 57.29 | 30.97 | 7 | 2016 | 11 | 50603090 |
| Mucosal inflammation | 56.73 | 30.97 | 29 | 1994 | 40113 | 50562988 |
| Iris transillumination defect | 53.76 | 30.97 | 8 | 2015 | 81 | 50603020 |
| Neutropenia | 52.61 | 30.97 | 45 | 1978 | 147920 | 50455181 |
| Thrombocytopenia | 51.97 | 30.97 | 42 | 1981 | 127631 | 50475470 |
| Leukopenia | 50.04 | 30.97 | 32 | 1991 | 67496 | 50535605 |
| Eye infection toxoplasmal | 44.60 | 30.97 | 8 | 2015 | 272 | 50602829 |
| Bladder perforation | 42.84 | 30.97 | 7 | 2016 | 135 | 50602966 |
| Hypotony of eye | 42.65 | 30.97 | 7 | 2016 | 139 | 50602962 |
| Necrotising scleritis | 42.65 | 30.97 | 7 | 2016 | 139 | 50602962 |
| Tractional retinal detachment | 41.82 | 30.97 | 6 | 2017 | 46 | 50603055 |
| Radiation skin injury | 41.13 | 30.97 | 9 | 2014 | 854 | 50602247 |
| Rhegmatogenous retinal detachment | 38.66 | 30.97 | 6 | 2017 | 82 | 50603019 |
| Extravasation | 38.38 | 30.97 | 10 | 2013 | 1992 | 50601109 |
| Pancytopenia | 37.04 | 30.97 | 29 | 1994 | 84001 | 50519100 |
| Disease progression | 33.68 | 30.97 | 29 | 1994 | 95837 | 50507264 |
| Conjunctival erosion | 32.98 | 30.97 | 5 | 2018 | 58 | 50603043 |
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 | 127.42 | 31.09 | 120 | 1671 | 300680 | 29272056 |
| Conjunctival filtering bleb leak | 82.45 | 31.09 | 10 | 1781 | 6 | 29572730 |
| Bladder perforation | 81.24 | 31.09 | 14 | 1777 | 244 | 29572492 |
| Iris hypopigmentation | 63.18 | 31.09 | 9 | 1782 | 40 | 29572696 |
| Scleral thinning | 56.66 | 31.09 | 7 | 1784 | 6 | 29572730 |
| NPM1 gene mutation | 54.69 | 31.09 | 9 | 1782 | 117 | 29572619 |
| Bronchiolitis obliterans syndrome | 51.99 | 31.09 | 9 | 1782 | 161 | 29572575 |
| Chimerism | 49.24 | 31.09 | 9 | 1782 | 222 | 29572514 |
| Post embolisation syndrome | 44.98 | 31.09 | 7 | 1784 | 62 | 29572674 |
| Bladder necrosis | 43.57 | 31.09 | 5 | 1786 | 0 | 29572736 |
| Scrotal ulcer | 39.26 | 31.09 | 8 | 1783 | 353 | 29572383 |
| Gastric perforation | 37.79 | 31.09 | 11 | 1780 | 2175 | 29570561 |
| Hypotony of eye | 35.23 | 31.09 | 6 | 1785 | 97 | 29572639 |
| Eosinophilic cystitis | 34.78 | 31.09 | 5 | 1786 | 24 | 29572712 |
| Blood immunoglobulin G decreased | 34.78 | 31.09 | 9 | 1782 | 1150 | 29571586 |
| Extravasation | 31.51 | 31.09 | 9 | 1782 | 1663 | 29571073 |
| Steroid diabetes | 31.36 | 31.09 | 9 | 1782 | 1692 | 29571044 |
| Conjunctival bleb | 31.19 | 31.09 | 4 | 1787 | 6 | 29572730 |
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 |
|---|---|---|---|---|---|---|
| Off label use | 185.52 | 26.79 | 206 | 3632 | 632600 | 63862294 |
| Conjunctival filtering bleb leak | 173.89 | 26.79 | 21 | 3817 | 12 | 64494882 |
| Scleral thinning | 143.26 | 26.79 | 18 | 3820 | 21 | 64494873 |
| Bladder perforation | 120.23 | 26.79 | 20 | 3818 | 284 | 64494610 |
| Hypotony of eye | 111.02 | 26.79 | 18 | 3820 | 216 | 64494678 |
| Scleromalacia | 87.31 | 26.79 | 10 | 3828 | 0 | 64494894 |
| Pulmonary veno-occlusive disease | 78.53 | 26.79 | 18 | 3820 | 1410 | 64493484 |
| Iris hypopigmentation | 77.57 | 26.79 | 11 | 3827 | 48 | 64494846 |
| Mucosal inflammation | 71.08 | 26.79 | 45 | 3793 | 62539 | 64432355 |
| NPM1 gene mutation | 60.93 | 26.79 | 10 | 3828 | 130 | 64494764 |
| Haemolytic uraemic syndrome | 60.05 | 26.79 | 18 | 3820 | 4003 | 64490891 |
| Conjunctival erosion | 56.30 | 26.79 | 9 | 3829 | 98 | 64494796 |
| Bronchiolitis obliterans syndrome | 54.59 | 26.79 | 10 | 3828 | 254 | 64494640 |
| Chimerism | 54.15 | 26.79 | 10 | 3828 | 266 | 64494628 |
| Encapsulating peritoneal sclerosis | 54.06 | 26.79 | 12 | 3826 | 813 | 64494081 |
| Iris transillumination defect | 54.01 | 26.79 | 9 | 3829 | 129 | 64494765 |
| Eosinophilic cystitis | 53.21 | 26.79 | 8 | 3830 | 56 | 64494838 |
| Post embolisation syndrome | 51.84 | 26.79 | 8 | 3830 | 68 | 64494826 |
| Neutropenia | 51.29 | 26.79 | 67 | 3771 | 239557 | 64255337 |
| Extravasation | 50.81 | 26.79 | 15 | 3823 | 3165 | 64491729 |
| Gastric perforation | 49.30 | 26.79 | 15 | 3823 | 3508 | 64491386 |
| Thrombocytopenia | 48.55 | 26.79 | 63 | 3775 | 223738 | 64271156 |
| Radiation skin injury | 48.36 | 26.79 | 12 | 3826 | 1318 | 64493576 |
| Bladder necrosis | 44.59 | 26.79 | 6 | 3832 | 16 | 64494878 |
| Necrotising scleritis | 44.15 | 26.79 | 8 | 3830 | 191 | 64494703 |
| Leukopenia | 43.81 | 26.79 | 41 | 3797 | 101201 | 64393693 |
| Conjunctival bleb | 43.36 | 26.79 | 6 | 3832 | 21 | 64494873 |
| Pupillary disorder | 43.32 | 26.79 | 9 | 3829 | 445 | 64494449 |
| Endophthalmitis | 43.10 | 26.79 | 15 | 3823 | 5350 | 64489544 |
| Scrotal ulcer | 40.63 | 26.79 | 8 | 3830 | 301 | 64494593 |
| Blebitis | 38.16 | 26.79 | 5 | 3833 | 10 | 64494884 |
| Eye infection toxoplasmal | 37.00 | 26.79 | 8 | 3830 | 479 | 64494415 |
| Choroidal detachment | 36.15 | 26.79 | 8 | 3830 | 534 | 64494360 |
| Tractional retinal detachment | 36.14 | 26.79 | 6 | 3832 | 84 | 64494810 |
| Palmar-plantar erythrodysaesthesia syndrome | 35.91 | 26.79 | 22 | 3816 | 28797 | 64466097 |
| Acute myeloid leukaemia recurrent | 35.33 | 26.79 | 11 | 3827 | 2773 | 64492121 |
| Pancytopenia | 35.25 | 26.79 | 43 | 3795 | 143266 | 64351628 |
| Chemical cystitis | 34.92 | 26.79 | 4 | 3834 | 0 | 64494894 |
| Visual acuity reduced | 34.53 | 26.79 | 21 | 3817 | 27120 | 64467774 |
| Acute promyelocytic leukaemia | 33.31 | 26.79 | 9 | 3829 | 1379 | 64493515 |
| Rhegmatogenous retinal detachment | 33.28 | 26.79 | 6 | 3832 | 139 | 64494755 |
| Hepatic artery stenosis | 33.08 | 26.79 | 6 | 3832 | 144 | 64494750 |
| Steroid diabetes | 31.61 | 26.79 | 10 | 3828 | 2656 | 64492238 |
| Blood immunoglobulin G decreased | 31.55 | 26.79 | 10 | 3828 | 2673 | 64492221 |
| Second primary malignancy | 31.02 | 26.79 | 15 | 3823 | 12322 | 64482572 |
| Anterior chamber pigmentation | 29.63 | 26.79 | 4 | 3834 | 11 | 64494883 |
| Disease progression | 29.29 | 26.79 | 39 | 3799 | 141641 | 64353253 |
| Corneal oedema | 28.66 | 26.79 | 9 | 3829 | 2334 | 64492560 |
FDA Adverse Event Reporting System (Pediatric)
None
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 |
| CHEBI has role | CHEBI:35610 | antineoplastic agents |
| 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 |
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 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
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)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.2MG/VIAL | MITOSOL | MOBIUS THERAP | N022572 | Feb. 7, 2012 | RX | FOR SOLUTION | TOPICAL | 9539241 | Jan. 2, 2028 | MITOSOL IS AN ANTIMETABOLITE INDICATED AS AN ADJUNCT TO AB EXTERNO GLAUCOMA SURGERY. IT IS INTENDED FOR TOPICAL APPLICATION TO THE SITE OF GLAUCOMA FILTRATION SURGERY |
| 0.2MG/VIAL | MITOSOL | MOBIUS THERAP | N022572 | Feb. 7, 2012 | RX | FOR SOLUTION | TOPICAL | 9649428 | May 21, 2029 | MITOSOL IS AN ANTIMETABOLITE INDICATED AS AN ADJUNCT TO AB EXTERNO GLAUCOMA SURGERY. IT IS INTENDED FOR TOPICAL APPLICATION TO THE SITE OF GLAUCOMA FILTRATION SURGERY |
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 |
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 |
| 140168 | 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 |
| MITOMYCIN | Human Prescription Drug Label | 1 | 68083-483 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 15 sections |
| MITOMYCIN | Human Prescription Drug Label | 1 | 68083-484 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 15 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 |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72819-152 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 18 sections |