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rufinamide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 3534 | 106308-44-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
The precise mechanism(s) by which rufinamide exerts its antiepileptic effect is unknown. The results of in vitro studies suggest that the principal mechanism of action of rufinamide is modulation of the activity of sodium channels and, in particular, prolongation of the inactive state of the channel.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 1.40 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.03 mg/mL | Bocci G, Oprea TI, Benet LZ |
| EoM (Fraction excreted unchanged in urine) | 1 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 191.92 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 85 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| fu (Fraction unbound in plasma) | 0.75 % | Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 0.753 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.411 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 89.743 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 2.286 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 68.480 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 82.980 | % | High | 1 |
| herg | hERG pIC50 | 4.021 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.282 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 2.965 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 68.080 | % | High | 1 |
| kinase-safety-class | ACVR2B,AXL,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,PDK1,PDK2,PDK4,PRKDC | 14 | |||
| kinase-selectivity-class | AXL,GRK2 | 2 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 2.427 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 1.143 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 72.770 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 2.254 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 81.120 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 1.766 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 96.730 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 73.770 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 862.979 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 16, 2007 | EMA | Eisai Ltd | |
| Nov. 14, 2008 | FDA | EISAI INC |
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 |
|---|---|---|---|---|---|---|
| Seizure | 364.08 | 55.34 | 119 | 1181 | 152510 | 90474637 |
| Drug resistance | 242.16 | 55.34 | 61 | 1239 | 30388 | 90596759 |
| Multiple-drug resistance | 155.30 | 55.34 | 33 | 1267 | 7743 | 90619404 |
| Drug ineffective | 127.35 | 55.34 | 124 | 1176 | 1384174 | 89242973 |
| Status epilepticus | 97.81 | 55.34 | 27 | 1273 | 18847 | 90608300 |
| Stillbirth | 79.70 | 55.34 | 19 | 1281 | 7424 | 90619723 |
| Atonic seizures | 57.55 | 55.34 | 10 | 1290 | 806 | 90626341 |
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 |
|---|---|---|---|---|---|---|
| Seizure | 254.88 | 49.44 | 113 | 1545 | 120448 | 42499229 |
| Multiple-drug resistance | 178.63 | 49.44 | 44 | 1614 | 7278 | 42612399 |
| Status epilepticus | 167.56 | 49.44 | 49 | 1609 | 15529 | 42604148 |
| Tonic convulsion | 130.23 | 49.44 | 26 | 1632 | 1633 | 42618044 |
| Drug ineffective | 96.30 | 49.44 | 119 | 1539 | 630078 | 41989599 |
| Epilepsy | 93.75 | 49.44 | 36 | 1622 | 26135 | 42593542 |
| Petit mal epilepsy | 89.23 | 49.44 | 22 | 1636 | 3628 | 42616049 |
| Somnolence | 82.70 | 49.44 | 57 | 1601 | 141048 | 42478629 |
| Treatment failure | 69.21 | 49.44 | 38 | 1620 | 62586 | 42557091 |
| Aggression | 63.58 | 49.44 | 32 | 1626 | 44131 | 42575546 |
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 |
|---|---|---|---|---|---|---|
| Seizure | 353.62 | 43.19 | 149 | 2569 | 221036 | 110365545 |
| Status epilepticus | 260.47 | 43.19 | 73 | 2645 | 31498 | 110555083 |
| Multiple-drug resistance | 243.59 | 43.19 | 58 | 2660 | 13177 | 110573404 |
| Drug resistance | 214.75 | 43.19 | 72 | 2646 | 56302 | 110530279 |
| Tonic convulsion | 161.82 | 43.19 | 32 | 2686 | 3042 | 110583539 |
| Epilepsy | 141.12 | 43.19 | 62 | 2656 | 100147 | 110486434 |
| Drug ineffective | 132.97 | 43.19 | 173 | 2545 | 1520367 | 109066214 |
| Somnolence | 131.97 | 43.19 | 85 | 2633 | 297364 | 110289217 |
| Petit mal epilepsy | 112.80 | 43.19 | 28 | 2690 | 7519 | 110579062 |
| Generalised tonic-clonic seizure | 80.65 | 43.19 | 35 | 2683 | 54645 | 110531936 |
| Off label use | 77.57 | 43.19 | 134 | 2584 | 1500051 | 109086530 |
| Aggression | 71.64 | 43.19 | 33 | 2685 | 59177 | 110527404 |
| Drug interaction | 68.23 | 43.19 | 72 | 2646 | 500111 | 110086470 |
| Myoclonic epilepsy | 66.47 | 43.19 | 15 | 2703 | 2676 | 110583905 |
| Atonic seizures | 60.63 | 43.19 | 12 | 2706 | 1142 | 110585439 |
| Seizure cluster | 58.20 | 43.19 | 11 | 2707 | 822 | 110585759 |
| Stillbirth | 49.80 | 43.19 | 13 | 2705 | 4251 | 110582330 |
| Anticonvulsant drug level increased | 49.79 | 43.19 | 12 | 2706 | 2846 | 110583735 |
| Fanconi syndrome | 47.31 | 43.19 | 12 | 2706 | 3507 | 110583074 |
| Behaviour disorder | 43.37 | 43.19 | 14 | 2704 | 9633 | 110576948 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N03AF03 | NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Carboxamide derivatives |
| MeSH PA | D000927 | Anticonvulsants |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D026941 | Sodium Channel Blockers |
| MeSH PA | D049990 | Membrane Transport Modulators |
| MeSH PA | D061567 | Voltage-Gated Sodium Channel Blockers |
| CHEBI has role | CHEBI:35480 | analgesic |
| CHEBI has role | CHEBI:35623 | anticonvulsant |
Related Drugs by ATC class:
N03AF Carboxamide derivatives 3 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Lennox-Gastaut syndrome | indication | 230418006 | |
| Atypical absence seizure | off-label use | 23374007 | |
| Atonic seizure | off-label use | 42365007 | |
| Absence seizure | off-label use | 79631006 | |
| Suicidal thoughts | contraindication | 6471006 | |
| Depressive disorder | contraindication | 35489007 | |
| Hepatic failure | contraindication | 59927004 | |
| Shortened QT interval | contraindication | 77867006 | |
| Leukopenia | contraindication | 84828003 | DOID:615 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Renal dialysis | contraindication | 265764009 | |
| Breastfeeding (mother) | contraindication | 413712001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.56 | acidic |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Sodium channel alpha subunit | Ion channel | BLOCKER | CHEMBL | CHEMBL | |||||
| Carbonic anhydrase 5A, mitochondrial | Enzyme | Ki | 6.46 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4025270 | VUID |
| N0000179367 | NUI |
| D05775 | KEGG_DRUG |
| 4025270 | VANDF |
| C0213404 | UMLSCUI |
| CHEBI:134966 | CHEBI |
| CHEMBL1201754 | ChEMBL_ID |
| DB06201 | DRUGBANK_ID |
| 129228 | PUBCHEM_CID |
| C079703 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7470 | IUPHAR_LIGAND_ID |
| 7387 | INN_ID |
| WFW942PR79 | UNII |
| 69036 | RXNORM |
| 158992 | MMSL |
| 24915 | MMSL |
| 340515 | MMSL |
| d07069 | MMSL |
| 012301 | NDDF |
| 429802008 | SNOMEDCT_US |
| 429835003 | SNOMEDCT_US |
| WFW942PR79 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0425 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 26 sections |
| Rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0426 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 26 sections |
| Rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0528 | SUSPENSION | 40 mg | ORAL | ANDA | 27 sections |
| Rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-598 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 25 sections |
| Rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-599 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 25 sections |
| Rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-688 | SUSPENSION | 40 mg | ORAL | ANDA | 25 sections |
| RUFINAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-391 | TABLET | 200 mg | ORAL | ANDA | 26 sections |
| RUFINAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-392 | TABLET | 400 mg | ORAL | ANDA | 26 sections |
| RUFINAMIDE | Human Prescription Drug Label | 1 | 59651-563 | SUSPENSION | 40 mg | ORAL | ANDA | 27 sections |
| Rufinamide | Human Prescription Drug Label | 1 | 59651-616 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 26 sections |
| Rufinamide | Human Prescription Drug Label | 1 | 59651-617 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 26 sections |
| Rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60687-824 | SUSPENSION | 40 mg | ORAL | ANDA | 26 sections |
| Banzel | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62856-582 | TABLET, FILM COATED | 200 mg | ORAL | NDA | 32 sections |
| Banzel | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62856-583 | TABLET, FILM COATED | 400 mg | ORAL | NDA | 32 sections |
| Banzel | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62856-584 | SUSPENSION | 40 mg | ORAL | NDA | 32 sections |
| Rufinamide | Human Prescription Drug Label | 1 | 67877-673 | SUSPENSION | 40 mg | ORAL | ANDA | 23 sections |
| Rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68180-797 | SUSPENSION | 40 mg | ORAL | ANDA | 26 sections |
| RUFINAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68180-802 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 26 sections |
| RUFINAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68180-803 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 26 sections |
| RUFINAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68180-804 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 26 sections |
| rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68462-713 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 24 sections |
| rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68462-714 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 24 sections |
| Rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69452-223 | SUSPENSION | 40 mg | ORAL | ANDA | 28 sections |
| Rufinamide | Human Prescription Drug Label | 1 | 72205-038 | SUSPENSION | 40 mg | ORAL | ANDA | 23 sections |
| Rufinamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72603-261 | SUSPENSION | 40 mg | ORAL | ANDA | 25 sections |