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lomustine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antineoplastic, alkylating agents, (beta-chloroethyl)amine derivatives | 1596 | 13010-47-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An alkylating agent of value against both hematologic malignancies and solid tumors.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 15.02 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 99 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| S (Water solubility) | 0.05 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,TEK | 18 | |||
| kinase-selectivity-class | AXL,BRAF,GRK2,STK33,TTK | 5 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 4, 1976 | FDA | CORDEN PHARMA |
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 |
|---|---|---|---|---|---|---|
| Thrombocytopenia | 109.19 | 30.84 | 65 | 2049 | 208660 | 90417673 |
| Eastern Cooperative Oncology Group performance status worsened | 72.16 | 30.84 | 15 | 2099 | 1924 | 90624409 |
| Mucosal inflammation | 71.01 | 30.84 | 32 | 2082 | 57593 | 90568740 |
| Neutropenia | 66.19 | 30.84 | 49 | 2065 | 224855 | 90401478 |
| Platelet count decreased | 62.08 | 30.84 | 39 | 2075 | 136930 | 90489403 |
| Death | 60.30 | 30.84 | 63 | 2051 | 456488 | 90169845 |
| Off label use | 56.03 | 30.84 | 95 | 2019 | 1102157 | 89524176 |
| Tumour pseudoprogression | 53.92 | 30.84 | 10 | 2104 | 711 | 90625622 |
| Ototoxicity | 49.37 | 30.84 | 11 | 2103 | 1953 | 90624380 |
| Disease progression | 47.98 | 30.84 | 35 | 2079 | 156580 | 90469753 |
| Nausea | 46.47 | 30.84 | 88 | 2026 | 1110228 | 89516105 |
| Neoplasm progression | 43.29 | 30.84 | 21 | 2093 | 44465 | 90581868 |
| Geotrichum infection | 42.61 | 30.84 | 8 | 2106 | 608 | 90625725 |
| Full blood count abnormal | 40.88 | 30.84 | 19 | 2095 | 36578 | 90589755 |
| Acute myeloid leukaemia | 40.60 | 30.84 | 16 | 2098 | 20624 | 90605709 |
| Malignant neoplasm progression | 35.25 | 30.84 | 25 | 2089 | 106845 | 90519488 |
| Second primary malignancy | 35.12 | 30.84 | 12 | 2102 | 10366 | 90615967 |
| Aspergilloma | 34.76 | 30.84 | 6 | 2108 | 283 | 90626050 |
| Bone marrow failure | 33.74 | 30.84 | 16 | 2098 | 32205 | 90594128 |
| Myelodysplastic syndrome | 33.53 | 30.84 | 14 | 2100 | 20889 | 90605444 |
| Post procedural diarrhoea | 33.17 | 30.84 | 6 | 2108 | 371 | 90625962 |
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 |
|---|---|---|---|---|---|---|
| Disease progression | 73.88 | 29.40 | 66 | 2662 | 143590 | 42475017 |
| Aeromonas infection | 63.11 | 29.40 | 12 | 2716 | 348 | 42618259 |
| Thrombocytopenia | 53.19 | 29.40 | 63 | 2665 | 190216 | 42428391 |
| Eastern Cooperative Oncology Group performance status worsened | 52.43 | 29.40 | 13 | 2715 | 1323 | 42617284 |
| Second primary malignancy | 43.51 | 29.40 | 18 | 2710 | 9557 | 42609050 |
| Seizure | 42.32 | 29.40 | 45 | 2683 | 120516 | 42498091 |
| Death | 41.48 | 29.40 | 92 | 2636 | 471093 | 42147514 |
| Fatigue | 37.11 | 29.40 | 84 | 2644 | 435557 | 42183050 |
| Hepatitis cholestatic | 36.46 | 29.40 | 16 | 2712 | 9808 | 42608799 |
| Platelet count decreased | 35.57 | 29.40 | 44 | 2684 | 138537 | 42480070 |
| Toxic skin eruption | 34.29 | 29.40 | 17 | 2711 | 13713 | 42604894 |
| Nausea | 33.18 | 29.40 | 76 | 2652 | 396723 | 42221884 |
| Necrotising fasciitis | 32.95 | 29.40 | 12 | 2716 | 4534 | 42614073 |
| Neutropenia | 31.29 | 29.40 | 50 | 2678 | 199381 | 42419226 |
| Hypermutation | 30.87 | 29.40 | 5 | 2723 | 55 | 42618552 |
| Tumour pseudoprogression | 30.31 | 29.40 | 8 | 2720 | 1042 | 42617565 |
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 |
|---|---|---|---|---|---|---|
| Thrombocytopenia | 144.74 | 26.93 | 113 | 4042 | 348772 | 110236372 |
| Eastern Cooperative Oncology Group performance status worsened | 126.92 | 26.93 | 28 | 4127 | 2941 | 110582203 |
| Disease progression | 114.15 | 26.93 | 85 | 4070 | 243949 | 110341195 |
| Tumour pseudoprogression | 84.55 | 26.93 | 18 | 4137 | 1598 | 110583546 |
| Neutropenia | 82.54 | 26.93 | 85 | 4070 | 374535 | 110210609 |
| Death | 82.07 | 26.93 | 115 | 4040 | 698754 | 109886390 |
| Off label use | 71.15 | 26.93 | 166 | 3989 | 1500019 | 109085125 |
| Second primary malignancy | 69.54 | 26.93 | 26 | 4129 | 18042 | 110567102 |
| Seizure | 69.24 | 26.93 | 61 | 4094 | 221124 | 110364020 |
| Neoplasm progression | 66.37 | 26.93 | 37 | 4118 | 64558 | 110520586 |
| Aeromonas infection | 64.70 | 26.93 | 12 | 4143 | 525 | 110584619 |
| Platelet count decreased | 61.27 | 26.93 | 58 | 4097 | 230385 | 110354759 |
| Acute myeloid leukaemia | 56.77 | 26.93 | 28 | 4127 | 38082 | 110547062 |
| Malignant neoplasm progression | 54.31 | 26.93 | 48 | 4107 | 174519 | 110410625 |
| Geotrichum infection | 49.42 | 26.93 | 11 | 4144 | 1201 | 110583943 |
| Myelodysplastic syndrome | 48.39 | 26.93 | 25 | 4130 | 37459 | 110547685 |
| Ototoxicity | 40.35 | 26.93 | 12 | 4143 | 4119 | 110581025 |
| Mucosal inflammation | 39.34 | 26.93 | 31 | 4124 | 96110 | 110489034 |
| Product use in unapproved indication | 38.65 | 26.93 | 64 | 4091 | 447313 | 110137831 |
| Haematotoxicity | 35.95 | 26.93 | 17 | 4138 | 21065 | 110564079 |
| Bone marrow failure | 35.87 | 26.93 | 24 | 4131 | 57824 | 110527320 |
| Hepatitis cholestatic | 35.70 | 26.93 | 16 | 4139 | 17550 | 110567594 |
| Glioblastoma | 33.98 | 26.93 | 9 | 4146 | 2031 | 110583113 |
| Cholestasis | 33.50 | 26.93 | 24 | 4131 | 64494 | 110520650 |
| Necrotising fasciitis | 33.18 | 26.93 | 12 | 4143 | 7579 | 110577565 |
| Hypermutation | 30.06 | 26.93 | 5 | 4150 | 115 | 110585029 |
| Hepatocellular injury | 28.99 | 26.93 | 20 | 4135 | 50622 | 110534522 |
| Toxic skin eruption | 28.89 | 26.93 | 16 | 4139 | 27499 | 110557645 |
| Post procedural diarrhoea | 28.74 | 26.93 | 6 | 4149 | 484 | 110584660 |
| Large granular lymphocytosis | 28.34 | 26.93 | 6 | 4149 | 518 | 110584626 |
| Myxoid liposarcoma | 27.86 | 26.93 | 4 | 4151 | 33 | 110585111 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01AD02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ALKYLATING AGENTS Nitrosoureas |
| FDA MoA | N0000000236 | Alkylating Activity |
| FDA EPC | N0000175558 | Alkylating Drug |
| MeSH PA | D000477 | Alkylating Agents |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D018906 | Antineoplastic Agents, Alkylating |
| CHEBI has role | CHEBI:22333 | alkylating agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Related Drugs by ATC class:
L01AD Nitrosoureas 7 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hodgkin's disease | indication | 118599009 | |
| Neoplasm of brain | indication | 126952004 | DOID:1319 |
| Allogeneic bone marrow transplantation | off-label use | 58390007 | |
| Mycosis | contraindication | 3218000 | DOID:1564 |
| Hyperbilirubinemia | contraindication | 14783006 | DOID:2741 |
| Viral disease | contraindication | 34014006 | DOID:934 |
| Fibrosis of lung | contraindication | 51615001 | DOID:3770 |
| Leukopenia | contraindication | 84828003 | DOID:615 |
| Bacterial infectious disease | contraindication | 87628006 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Bleeding | contraindication | 131148009 | |
| Liver function tests abnormal | contraindication | 166603001 | |
| Drug-induced hepatitis | contraindication | 235876009 | |
| 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 | 12.87 | acidic |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 100MG | LOMUSTINE | CARNEGIE | A219265 | Oct. 27, 2025 | RX | CAPSULE | ORAL | May 19, 2026 | COMPETITIVE GENERIC THERAPY |
| 10MG | LOMUSTINE | CARNEGIE | A219265 | Oct. 27, 2025 | RX | CAPSULE | ORAL | May 19, 2026 | COMPETITIVE GENERIC THERAPY |
| 40MG | LOMUSTINE | CARNEGIE | A219265 | Oct. 27, 2025 | RX | CAPSULE | ORAL | May 19, 2026 | COMPETITIVE GENERIC THERAPY |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 4018138 | VUID |
| N0000146475 | NUI |
| D00363 | KEGG_DRUG |
| 4018138 | VANDF |
| C0023972 | UMLSCUI |
| CHEBI:6520 | CHEBI |
| CHEMBL514 | ChEMBL_ID |
| DB01206 | DRUGBANK_ID |
| D008130 | MESH_DESCRIPTOR_UI |
| 3950 | PUBCHEM_CID |
| 7214 | IUPHAR_LIGAND_ID |
| 3184 | INN_ID |
| 7BRF0Z81KG | UNII |
| 6466 | RXNORM |
| 4991 | MMSL |
| 52513 | MMSL |
| d01341 | MMSL |
| 002639 | NDDF |
| 387227009 | SNOMEDCT_US |
| 40999006 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Gleostine | Human Prescription Drug Label | 1 | 24338-340 | CAPSULE, GELATIN COATED | 10 mg | ORAL | NDA | 24 sections |
| Gleostine | Human Prescription Drug Label | 1 | 24338-341 | CAPSULE, GELATIN COATED | 40 mg | ORAL | NDA | 24 sections |
| Gleostine | Human Prescription Drug Label | 1 | 24338-342 | CAPSULE, GELATIN COATED | 100 mg | ORAL | NDA | 24 sections |
| Lomustine | Human Prescription Drug Label | 1 | 52536-340 | CAPSULE, GELATIN COATED | 10 mg | ORAL | NDA | 24 sections |
| Lomustine | Human Prescription Drug Label | 1 | 52536-341 | CAPSULE, GELATIN COATED | 40 mg | ORAL | NDA | 24 sections |
| Lomustine | Human Prescription Drug Label | 1 | 52536-342 | CAPSULE, GELATIN COATED | 100 mg | ORAL | NDA | 24 sections |
| Gleostine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 58181-3040 | CAPSULE, GELATIN COATED | 10 mg | ORAL | NDA | 24 sections |
| Gleostine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 58181-3041 | CAPSULE, GELATIN COATED | 40 mg | ORAL | NDA | 24 sections |
| Gleostine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 58181-3042 | CAPSULE, GELATIN COATED | 100 mg | ORAL | NDA | 24 sections |
| LOMUSTINE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80005-114 | CAPSULE | 10 mg | ORAL | ANDA | 25 sections |
| LOMUSTINE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80005-115 | CAPSULE | 40 mg | ORAL | ANDA | 25 sections |
| LOMUSTINE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80005-116 | CAPSULE | 100 mg | ORAL | ANDA | 25 sections |