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fidaxomicin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| aminoglycosides, antibiotics obtained from various Micromonospora | 4180 | 873857-62-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Fidaxomicin is a fermentation product obtained from the Actinomycete Dactylosporangium aurantiacum. In vitro, fidaxomicin is active primarily against species of clostridia, including Clostridium difficile by inhibiting RNA synthesis by RNA polymerases.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.40 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BA (Bioavailability) | 0 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK3,MAP2K6,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CG,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1,ZAP70 | 32 | |||
| kinase-selectivity-class | AXL,GRK2,MAP2K6 | 3 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 2, 2018 | PMDA | Astellas Pharma Inc | |
| May 27, 2011 | FDA | CUBIST PHARMS |
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 |
|---|---|---|---|---|---|---|
| Clostridium difficile infection | 193.29 | 30.02 | 58 | 1901 | 36187 | 90590301 |
| Disease recurrence | 128.86 | 30.02 | 43 | 1916 | 37610 | 90588878 |
| Drug ineffective | 73.05 | 30.02 | 116 | 1843 | 1384182 | 89242306 |
| Clostridium test positive | 72.89 | 30.02 | 18 | 1941 | 5383 | 90621105 |
| Avian influenza | 58.96 | 30.02 | 8 | 1951 | 78 | 90626410 |
| Clostridium difficile colitis | 58.79 | 30.02 | 22 | 1937 | 26684 | 90599804 |
| Cytomegalovirus viraemia | 52.96 | 30.02 | 15 | 1944 | 7571 | 90618917 |
| Pseudomembranous colitis | 47.72 | 30.02 | 12 | 1947 | 3856 | 90622632 |
| Renal graft infection | 46.95 | 30.02 | 8 | 1951 | 378 | 90626110 |
| Klebsiella test positive | 41.67 | 30.02 | 9 | 1950 | 1494 | 90624994 |
| Urinary tract infection pseudomonal | 39.69 | 30.02 | 8 | 1951 | 950 | 90625538 |
| Weaning failure | 37.88 | 30.02 | 7 | 1952 | 527 | 90625961 |
| Diarrhoea | 33.87 | 30.02 | 67 | 1892 | 939123 | 89687365 |
| Peptic ulcer perforation | 32.46 | 30.02 | 6 | 1953 | 452 | 90626036 |
| Parvovirus infection | 31.95 | 30.02 | 6 | 1953 | 493 | 90625995 |
| Fluid balance positive | 31.19 | 30.02 | 4 | 1955 | 24 | 90626464 |
| No adverse event | 31.18 | 30.02 | 19 | 1940 | 67963 | 90558525 |
| Epstein-Barr viraemia | 30.81 | 30.02 | 7 | 1952 | 1463 | 90625025 |
| Hypovolaemia | 30.13 | 30.02 | 11 | 1948 | 12420 | 90614068 |
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 |
|---|---|---|---|---|---|---|
| Clostridium difficile infection | 105.80 | 47.68 | 34 | 1048 | 22625 | 42597628 |
| Agranulocytosis | 69.89 | 47.68 | 27 | 1055 | 30585 | 42589668 |
| Megacolon | 62.96 | 47.68 | 14 | 1068 | 2271 | 42617982 |
| Drug ineffective | 58.54 | 47.68 | 75 | 1007 | 630122 | 41990131 |
| Diarrhoea | 54.29 | 47.68 | 62 | 1020 | 460787 | 42159466 |
| Pathogen resistance | 48.54 | 47.68 | 16 | 1066 | 11434 | 42608819 |
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 |
|---|---|---|---|---|---|---|
| Clostridium difficile infection | 238.35 | 33.74 | 77 | 2727 | 52052 | 110534443 |
| Drug ineffective | 103.14 | 33.74 | 156 | 2648 | 1520384 | 109066111 |
| Disease recurrence | 88.80 | 33.74 | 39 | 2765 | 60745 | 110525750 |
| Clostridium difficile colitis | 87.10 | 33.74 | 35 | 2769 | 43743 | 110542752 |
| Pseudomembranous colitis | 71.75 | 33.74 | 19 | 2785 | 6372 | 110580123 |
| Clostridium test positive | 70.31 | 33.74 | 21 | 2783 | 10872 | 110575623 |
| Diarrhoea | 60.44 | 33.74 | 105 | 2699 | 1139400 | 109447095 |
| Megacolon | 59.00 | 33.74 | 15 | 2789 | 4290 | 110582205 |
| Agranulocytosis | 57.35 | 33.74 | 29 | 2775 | 61731 | 110524764 |
| Avian influenza | 54.94 | 33.74 | 8 | 2796 | 113 | 110586382 |
| Septic shock | 51.81 | 33.74 | 38 | 2766 | 157490 | 110429005 |
| Cytomegalovirus viraemia | 48.89 | 33.74 | 18 | 2786 | 17746 | 110568749 |
| Pneumonia aspiration | 42.09 | 33.74 | 26 | 2778 | 81207 | 110505288 |
| Renal graft infection | 40.06 | 33.74 | 8 | 2796 | 771 | 110585724 |
| Drug reaction with eosinophilia and systemic symptoms | 39.32 | 33.74 | 25 | 2779 | 82070 | 110504425 |
| Pathogen resistance | 38.15 | 33.74 | 15 | 2789 | 17657 | 110568838 |
| Treatment failure | 36.78 | 33.74 | 40 | 2764 | 277194 | 110309301 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A07AA12 | ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFECTIVES Antibiotics |
| FDA CS | M0028311 | Macrolides |
| FDA EPC | N0000175431 | Macrolide Antibacterial |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000900 | Anti-Bacterial Agents |
| CHEBI has role | CHEBI:36047 | antibacterial drug |
| CHEBI has role | CHEBI:37416 | EC 2.7.7.6 (RNA polymerase) inhibitor |
| CHEBI has role | CHEBI:76969 | bacterial metabolite |
Related Drugs by ATC class:
A07AA Antibiotics 12 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Clostridium difficile infection | indication | 186431008 | |
| Pseudomembranous enterocolitis | indication | 397683000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.95 | acidic |
| pKa2 | 9.53 | acidic |
| pKa3 | 11.96 | acidic |
| pKa4 | 12.76 | acidic |
| pKa5 | 13.32 | acidic |
| pKa6 | 13.74 | acidic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 200MG | DIFICID | CUBIST PHARMS LLC | N201699 | May 27, 2011 | RX | TABLET | ORAL | 7906489 | March 4, 2027 | TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER |
| 200MG | DIFICID | CUBIST PHARMS LLC | N201699 | May 27, 2011 | RX | TABLET | ORAL | 7906489 | March 4, 2027 | TREATMENT OF MICROBIAL INFECTIONS |
| 40MG/ML | DIFICID | CUBIST PHARMS LLC | N213138 | Jan. 24, 2020 | RX | FOR SUSPENSION | ORAL | 7906489 | March 4, 2027 | TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER |
| 200MG | DIFICID | CUBIST PHARMS LLC | N201699 | May 27, 2011 | RX | TABLET | ORAL | 8859510 | July 31, 2027 | TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER |
| 200MG | DIFICID | CUBIST PHARMS LLC | N201699 | May 27, 2011 | RX | TABLET | ORAL | 8859510 | July 31, 2027 | TREATMENT OF MICROBIAL INFECTIONS |
| 40MG/ML | DIFICID | CUBIST PHARMS LLC | N213138 | Jan. 24, 2020 | RX | FOR SUSPENSION | ORAL | 8859510 | July 31, 2027 | TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 200MG | DIFICID | CUBIST PHARMS LLC | N201699 | May 27, 2011 | RX | TABLET | ORAL | Jan. 24, 2027 | PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD) |
| 40MG/ML | DIFICID | CUBIST PHARMS LLC | N213138 | Jan. 24, 2020 | RX | FOR SUSPENSION | ORAL | Jan. 24, 2027 | PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| DNA-directed RNA polymerase | Enzyme | INHIBITOR | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4030846 | VUID |
| N0000182832 | NUI |
| D09394 | KEGG_DRUG |
| 4030846 | VANDF |
| FI8 | PDB_CHEM_ID |
| CHEMBL1255800 | ChEMBL_ID |
| CHEMBL445546 | ChEMBL_ID |
| 10909 | IUPHAR_LIGAND_ID |
| DB08874 | DRUGBANK_ID |
| Z5N076G8YQ | UNII |
| 1111103 | RXNORM |
| 181510 | MMSL |
| 27891 | MMSL |
| 385338 | MMSL |
| d07778 | MMSL |
| 013814 | NDDF |
| 703664004 | SNOMEDCT_US |
| 703665003 | SNOMEDCT_US |
| C0065023 | UMLSCUI |
| D000077732 | MESH_DESCRIPTOR_UI |
| CHEBI:68590 | CHEBI |
| 9038 | INN_ID |
| 10034073 | PUBCHEM_CID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Fidaxomicin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0480-2596 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 27 sections |
| Fidaxomicin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-745 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 22 sections |
| Dificid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52015-080 | TABLET, FILM COATED | 200 mg | ORAL | NDA | 30 sections |
| Dificid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52015-080 | TABLET, FILM COATED | 200 mg | ORAL | NDA | 30 sections |
| DIFICID | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52015-700 | GRANULE, FOR SUSPENSION | 200 mg | ORAL | NDA | 30 sections |
| DIFICID | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52015-700 | GRANULE, FOR SUSPENSION | 200 mg | ORAL | NDA | 30 sections |
| Fidaxomicin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4833 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 27 sections |