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dofetilide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| class III antiarrhythmics | 942 | 115256-11-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Dofetilide show Vaughan Williams Class III antiarrhythmic activity. The mechanism of action is blockade of the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current, IKr. At concentrations covering several orders of magnitude, dofetilide blocks only IKr with no relevant block of the other repolarizing potassium currents (e.g., IKs, IK1). At clinically relevant concentrations, dofetilide has no effect on sodium channels (associated with Class I effect), adrenergic alpha-receptors, or adrenergic beta-receptors.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 64 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.04 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 96 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 3.30 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 5.20 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.36 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 8.10 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 0.02 mg/mL | 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,ERBB2,GRK2,ITK,MAP2K6,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK | 19 | |||
| kinase-selectivity-class | ERBB2,GRK2,MAP2K6,TEK | 4 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 17.701 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| rat-kpuu-brain | Rat brain Kpuu | 0.021 | % | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 1, 1999 | FDA | PFIZER |
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 |
|---|---|---|---|---|---|---|
| Torsade de pointes | 239.52 | 24.29 | 68 | 4424 | 15114 | 90608841 |
| Electrocardiogram QT prolonged | 191.48 | 24.29 | 86 | 4406 | 72370 | 90551585 |
| Atrial fibrillation | 157.52 | 24.29 | 92 | 4400 | 133519 | 90490436 |
| Death | 117.68 | 24.29 | 128 | 4364 | 456423 | 90167532 |
| Ventricular tachycardia | 83.70 | 24.29 | 35 | 4457 | 24673 | 90599282 |
| Arrhythmia | 77.23 | 24.29 | 39 | 4453 | 42293 | 90581662 |
| Palpitations | 60.97 | 24.29 | 52 | 4440 | 136676 | 90487279 |
| Ventricular fibrillation | 51.29 | 24.29 | 21 | 4471 | 14023 | 90609932 |
| Therapy cessation | 50.69 | 24.29 | 28 | 4464 | 36333 | 90587622 |
| Cardiac pacemaker insertion | 48.68 | 24.29 | 15 | 4477 | 4392 | 90619563 |
| Atrial flutter | 45.91 | 24.29 | 18 | 4474 | 10740 | 90613215 |
| Dyspnoea | 45.64 | 24.29 | 120 | 4372 | 880835 | 89743120 |
| Cardiac ablation | 42.66 | 24.29 | 11 | 4481 | 1693 | 90622262 |
| Heart rate increased | 40.50 | 24.29 | 38 | 4454 | 112864 | 90511091 |
| Cardioversion | 40.00 | 24.29 | 10 | 4482 | 1360 | 90622595 |
| Hospitalisation | 38.26 | 24.29 | 39 | 4453 | 128061 | 90495894 |
| Heart rate irregular | 37.46 | 24.29 | 20 | 4472 | 24248 | 90599707 |
| Drug ineffective | 31.26 | 24.29 | 143 | 4349 | 1384155 | 89239800 |
| Dizziness | 31.13 | 24.29 | 81 | 4411 | 589203 | 90034752 |
| Blood potassium decreased | 29.47 | 24.29 | 22 | 4470 | 47705 | 90576250 |
| Cardiac failure congestive | 29.37 | 24.29 | 30 | 4462 | 98664 | 90525291 |
| Product prescribing error | 25.86 | 24.29 | 17 | 4475 | 30128 | 90593827 |
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 |
|---|---|---|---|---|---|---|
| Electrocardiogram QT prolonged | 602.40 | 22.09 | 221 | 4739 | 47724 | 42568651 |
| Ventricular tachycardia | 190.09 | 22.09 | 85 | 4875 | 30075 | 42586300 |
| Torsade de pointes | 187.01 | 22.09 | 60 | 4900 | 8534 | 42607841 |
| Death | 90.40 | 22.09 | 180 | 4780 | 471005 | 42145370 |
| Atrial fibrillation | 86.11 | 22.09 | 93 | 4867 | 139500 | 42476875 |
| Palpitations | 69.39 | 22.09 | 53 | 4907 | 50744 | 42565631 |
| Arrhythmia | 59.34 | 22.09 | 44 | 4916 | 40273 | 42576102 |
| Wrong strength | 55.28 | 22.09 | 10 | 4950 | 116 | 42616259 |
| Cardiac arrest | 50.77 | 22.09 | 63 | 4897 | 109257 | 42507118 |
| Ventricular fibrillation | 49.14 | 22.09 | 35 | 4925 | 30088 | 42586287 |
| Product substitution issue | 38.56 | 22.09 | 21 | 4939 | 11269 | 42605106 |
| Therapy cessation | 36.23 | 22.09 | 25 | 4935 | 20425 | 42595950 |
| Ventricular extrasystoles | 32.64 | 22.09 | 20 | 4940 | 13370 | 42603005 |
| Cardiac disorder | 32.53 | 22.09 | 34 | 4926 | 48898 | 42567477 |
| Heart rate irregular | 31.72 | 22.09 | 21 | 4939 | 16029 | 42600346 |
| Hospitalisation | 31.55 | 22.09 | 41 | 4919 | 74289 | 42542086 |
| Atrial flutter | 30.34 | 22.09 | 21 | 4939 | 17230 | 42599145 |
| Cardioversion | 30.25 | 22.09 | 9 | 4951 | 992 | 42615383 |
| Product prescribing error | 28.68 | 22.09 | 24 | 4936 | 26088 | 42590287 |
| Cardiac failure congestive | 28.50 | 22.09 | 42 | 4918 | 85560 | 42530815 |
| Dizziness | 28.41 | 22.09 | 78 | 4882 | 249176 | 42367199 |
| Drug ineffective | 28.41 | 22.09 | 146 | 4814 | 630051 | 41986324 |
| Cardiac ablation | 28 | 22.09 | 9 | 4951 | 1281 | 42615094 |
| Electrocardiogram T wave biphasic | 26.64 | 22.09 | 6 | 4954 | 219 | 42616156 |
| Dyspnoea | 22.31 | 22.09 | 106 | 4854 | 442515 | 42173860 |
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 |
|---|---|---|---|---|---|---|
| Electrocardiogram QT prolonged | 650.80 | 21.11 | 253 | 7295 | 108707 | 110473044 |
| Torsade de pointes | 378.90 | 21.11 | 114 | 7434 | 22486 | 110559265 |
| Ventricular tachycardia | 241.79 | 21.11 | 100 | 7448 | 49909 | 110531842 |
| Death | 181.76 | 21.11 | 230 | 7318 | 698639 | 109883112 |
| Atrial fibrillation | 148.93 | 21.11 | 124 | 7424 | 229518 | 110352233 |
| Palpitations | 109.44 | 21.11 | 89 | 7459 | 159123 | 110422628 |
| Ventricular fibrillation | 93.87 | 21.11 | 49 | 7499 | 41264 | 110540487 |
| Cardiac arrest | 83.77 | 21.11 | 84 | 7464 | 196669 | 110385082 |
| Arrhythmia | 77.35 | 21.11 | 52 | 7496 | 69523 | 110512228 |
| Wrong strength | 73.99 | 21.11 | 13 | 7535 | 224 | 110581527 |
| Atrial flutter | 61.53 | 21.11 | 31 | 7517 | 24231 | 110557520 |
| Therapy cessation | 60.85 | 21.11 | 38 | 7510 | 44819 | 110536932 |
| Cardiac ablation | 60.23 | 21.11 | 17 | 7531 | 2665 | 110579086 |
| Dyspnoea | 55.23 | 21.11 | 183 | 7365 | 1106689 | 109475062 |
| Cardiac failure congestive | 54.41 | 21.11 | 59 | 7489 | 150941 | 110430810 |
| Product prescribing error | 53.79 | 21.11 | 37 | 7511 | 51294 | 110530457 |
| Heart rate irregular | 51.50 | 21.11 | 31 | 7517 | 34243 | 110547508 |
| Cardiac pacemaker insertion | 45.96 | 21.11 | 17 | 7531 | 6284 | 110575467 |
| Cardioversion | 44.46 | 21.11 | 13 | 7535 | 2310 | 110579441 |
| Drug ineffective | 44.00 | 21.11 | 212 | 7336 | 1520328 | 109061423 |
| Hospitalisation | 41.70 | 21.11 | 50 | 7498 | 142443 | 110439308 |
| Dizziness | 39.77 | 21.11 | 121 | 7427 | 698072 | 109883679 |
| Product dispensing error | 38.87 | 21.11 | 20 | 7528 | 16325 | 110565426 |
| Heart rate increased | 38.09 | 21.11 | 48 | 7500 | 143786 | 110437965 |
| Cardiac disorder | 36.96 | 21.11 | 35 | 7513 | 76245 | 110505506 |
| Blood potassium decreased | 32.45 | 21.11 | 28 | 7520 | 54086 | 110527665 |
| Therapy interrupted | 32.38 | 21.11 | 27 | 7521 | 49795 | 110531956 |
| Hypoacusis | 31.39 | 21.11 | 23 | 7525 | 35168 | 110546583 |
| Electrocardiogram T wave biphasic | 29.41 | 21.11 | 6 | 7542 | 235 | 110581516 |
| Cerebrovascular accident | 28.18 | 21.11 | 47 | 7501 | 181237 | 110400514 |
| Ventricular extrasystoles | 27.76 | 21.11 | 18 | 7530 | 22623 | 110559128 |
| Product substitution issue | 27.45 | 21.11 | 18 | 7530 | 23043 | 110558708 |
| Surgery | 26.06 | 21.11 | 22 | 7526 | 41261 | 110540490 |
| Cardiac flutter | 26.05 | 21.11 | 11 | 7537 | 5746 | 110576005 |
| Extrasystoles | 25.19 | 21.11 | 12 | 7536 | 8306 | 110573445 |
| Dyspnoea exertional | 21.82 | 21.11 | 31 | 7517 | 104029 | 110477722 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C01BD04 | CARDIOVASCULAR SYSTEM CARDIAC THERAPY ANTIARRHYTHMICS, CLASS I AND III Antiarrhythmics, class III |
| FDA EPC | N0000175426 | Antiarrhythmic |
| MeSH PA | D000889 | Anti-Arrhythmia Agents |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D026902 | Potassium Channel Blockers |
| MeSH PA | D049990 | Membrane Transport Modulators |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:38070 | anti-arrhythmia drug |
| CHEBI has role | CHEBI:50509 | potassium channel blocker |
Related Drugs by ATC class:
C01BD Antiarrhythmics, class III 6 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Atrial fibrillation | indication | 49436004 | DOID:0060224 |
| Cardioversion of Atrial Fibrillation | indication | ||
| Cardioversion of Atrial Flutter | indication | ||
| Torsades de pointes | contraindication | 31722008 | |
| Hypokalemia | contraindication | 43339004 | |
| Anorexia nervosa | contraindication | 56882008 | DOID:8689 |
| Acute nephropathy | contraindication | 58574008 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Prolonged QT interval | contraindication | 111975006 | |
| Hypomagnesemia | contraindication | 190855004 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Hyperhidrosis | contraindication | 312230002 | |
| Severe diarrhea | contraindication | 409587002 | |
| Vomiting | contraindication | 422400008 | |
| Congenital long QT syndrome | contraindication | 442917000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.4 | acidic |
| pKa2 | 9.16 | acidic |
| pKa3 | 8.0 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Potassium voltage-gated channel subfamily H member 2 | Ion channel | BLOCKER | Ki | 8.19 | CHEMBL | CHEMBL | |||
| Potassium voltage-gated channel subfamily H member 1 | Ion channel | BLOCKER | IC50 | 7.50 | IUPHAR | ||||
| Potassium channel subfamily K member 2 | Ion channel | WOMBAT-PK |
External reference:
| ID | Source |
|---|---|
| 4021202 | VUID |
| N0000148648 | NUI |
| D00647 | KEGG_DRUG |
| 261672 | RXNORM |
| 4021202 | VANDF |
| C0114771 | UMLSCUI |
| CHEBI:4681 | CHEBI |
| CHEMBL473 | ChEMBL_ID |
| DB00204 | DRUGBANK_ID |
| C063533 | MESH_SUPPLEMENTAL_RECORD_UI |
| 2604 | IUPHAR_LIGAND_ID |
| 6756 | INN_ID |
| R4Z9X1N2ND | UNII |
| 71329 | PUBCHEM_CID |
| 241646 | MMSL |
| 31824 | MMSL |
| 8476 | MMSL |
| d04459 | MMSL |
| 007996 | NDDF |
| 116107002 | SNOMEDCT_US |
| 392658005 | SNOMEDCT_US |
| R4Z9X1N2ND | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Tikosyn | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-5800 | CAPSULE | 0.13 mg | ORAL | NDA | 25 sections |
| Tikosyn | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-5810 | CAPSULE | 0.25 mg | ORAL | NDA | 25 sections |
| Tikosyn | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-5820 | CAPSULE | 0.50 mg | ORAL | NDA | 25 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7522 | CAPSULE | 0.13 mg | ORAL | ANDA | 25 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7523 | CAPSULE | 0.25 mg | ORAL | ANDA | 25 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7524 | CAPSULE | 0.50 mg | ORAL | ANDA | 25 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-490 | CAPSULE | 0.13 mg | ORAL | ANDA | 25 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-490 | CAPSULE | 0.13 mg | ORAL | ANDA | 25 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-491 | CAPSULE | 0.25 mg | ORAL | ANDA | 25 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-491 | CAPSULE | 0.25 mg | ORAL | ANDA | 25 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-492 | CAPSULE | 0.50 mg | ORAL | ANDA | 25 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-492 | CAPSULE | 0.50 mg | ORAL | ANDA | 25 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42794-044 | CAPSULE | 125 ug | ORAL | ANDA | 24 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42794-045 | CAPSULE | 250 ug | ORAL | ANDA | 24 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42794-046 | CAPSULE | 500 ug | ORAL | ANDA | 24 sections |
| DOFETILIDE | Human Prescription Drug Label | 1 | 47335-061 | CAPSULE | 0.13 mg | ORAL | ANDA | 23 sections |
| DOFETILIDE | Human Prescription Drug Label | 1 | 47335-062 | CAPSULE | 0.25 mg | ORAL | ANDA | 23 sections |
| DOFETILIDE | Human Prescription Drug Label | 1 | 47335-063 | CAPSULE | 0.50 mg | ORAL | ANDA | 23 sections |
| Dofetilide | Human Prescription Drug Label | 1 | 59651-118 | CAPSULE | 0.13 mg | ORAL | ANDA | 23 sections |
| Dofetilide | Human Prescription Drug Label | 1 | 59651-119 | CAPSULE | 0.25 mg | ORAL | ANDA | 23 sections |
| Dofetilide | Human Prescription Drug Label | 1 | 59651-120 | CAPSULE | 0.50 mg | ORAL | ANDA | 23 sections |
| Tikosyn | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69189-5800 | CAPSULE | 0.13 mg | ORAL | NDA | 25 sections |
| Tikosyn | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69189-5810 | CAPSULE | 0.25 mg | ORAL | NDA | 25 sections |
| Tikosyn | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69189-5820 | CAPSULE | 0.50 mg | ORAL | NDA | 25 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69452-131 | CAPSULE | 0.13 mg | ORAL | ANDA | 24 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69452-132 | CAPSULE | 0.25 mg | ORAL | ANDA | 24 sections |
| Dofetilide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69452-133 | CAPSULE | 0.50 mg | ORAL | ANDA | 24 sections |
| Dofetilide 0.125mg | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70010-024 | CAPSULE | 0.13 mg | ORAL | ANDA | 22 sections |
| Dofetilide 0.25mg | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70010-025 | CAPSULE | 0.25 mg | ORAL | ANDA | 22 sections |
| Dofetilide 0.5mg | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70010-026 | CAPSULE | 0.50 mg | ORAL | ANDA | 22 sections |