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Xcopri
cenobamate
Adult Dosing .
Dosage forms: TAB: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg
partial seizures
- [200 mg PO qd]
- Start: 12.5 mg PO qd x2wk, then 25 mg PO qd x2wk, then 50 mg PO qd x2wk, then incr. by 50 mg/day q2wk until 200 mg PO qd, then may incr. by 50 mg/day q2wk; Max: 400 mg/day; Info: taper dose gradually over >2wk to D/C
renal dosing
- [see below]
- renal impairment: consider decr. usual dose
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: consider decr. usual dose, max 200 mg/day; Child-Pugh Class C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- short QT syndrome, familial
- hepatic impairment, Child-Pugh Class C
- abrupt withdrawal
- caution: hepatic impairment, Child-Pugh Class A-B
- caution: renal impairment
- caution: CNS depressant use, concurrent
- caution: alcohol use, concurrent
- caution: suicide risk
Drug Interactions .
Overview
cenobamate
carbamate
- CYP2C19 inhibitor, moderate
- CYP2B6 inducer, weak
- CYP3A4 inducer, moderate
- affected by altered fat absorption
- antiepileptic agent
- CNS depression
- shortens QT interval
Contraindicated
- amifampridine
- bupropion
- dalfampridine
- lonafarnib
- mavacamten
- ranolazine
Avoid/Use Alternative
- abemaciclib
- abrocitinib
- alfentanil
- alpelisib
- aprepitant
- artemether/lumefantrine
- atazanavir
- atogepant
- atrasentan
- avacopan
- avapritinib
- axitinib
- bedaquiline
- bictegravir
- bosutinib
- brigatinib
- buprenorphine
- buspirone
- butalbital
- cabozantinib
- capivasertib
- capmatinib
- cariprazine
- clarithromycin
- clonidine
- clopidogrel
- cobicistat
- cobimetinib
- codeine
- crizotinib
- daridorexant
- darolutamide
- defactinib
- deflazacort
- desogestrel (contraceptive)
- diazoxide
- dienogest (contraceptive)
- dihydrocodeine
- diltiazem
- dolutegravir
- doravirine
- doxorubicin
- doxylamine
- dronedarone
- drospirenone (contraceptive)
- duvelisib
- elacestrant
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- elvitegravir
- ensartinib
- entrectinib
- erdafitinib
- erlotinib
- estradiol (contraceptive)
- ethanol
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- everolimus
- fedratinib
- felodipine
- fentanyl
- finerenone
- fosamprenavir
- fosaprepitant
- fostamatinib
- fruquintinib
- ganaxolone
- gilteritinib
- ginkgo
- glasdegib
- glecaprevir
- grazoprevir
- hydrocodone
- ibrexafungerp
- ibrutinib
- idelalisib
- imatinib
- irinotecan
- isavuconazonium
- isocarboxazid
- isradipine
- istradefylline
- itraconazole
- ivacaftor
- ivosidenib
- kava
- ketoconazole
- kratom
- larotrectinib
- lazertinib
- lefamulin
- lemborexant
- lenacapavir
- leniolisib
- letermovir
- levoketoconazole
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- lopinavir/ritonavir
- lorlatinib
- lumateperone
- macitentan
- maraviroc
- medroxyprogesterone (contraceptive)
- meperidine
- metaxalone
- methadone
- metoclopramide
- midazolam
- midostaurin
- mifepristone
- mitapivat
- mobocertinib
- naldemedine
- naloxegol
- nefazodone
- nelfinavir
- neratinib
- netupitant
- nevirapine
- nicardipine
- nifedipine
- nilotinib
- nirmatrelvir
- nirogacestat
- nisoldipine
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- olaparib
- oliceridine
- olutasidenib
- omaveloxolone
- oxybate
- oxycodone
- palbociclib
- palovarotene
- pemigatinib
- phenelzine
- pimavanserin
- pirfenidone
- pirtobrutinib
- ponatinib
- pralsetinib
- praziquantel
- pretomanid
- promethazine
- quizartinib
- repotrectinib
- revumenib
- ribociclib
- rilpivirine
- rimegepant
- ripretinib
- ritonavir
- rivaroxaban
- roflumilast
- rolapitant
- ropeginterferon alfa-2b
- samidorphan
- segesterone (contraceptive)
- selpercatinib
- selumetinib
- simvastatin
- siponimod
- sonidegib
- sufentanil
- suzetrigine
- tadalafil
- tamoxifen
- tasimelteon
- tazemetostat
- tezacaftor/ivacaftor
- thalidomide
- thiotepa
- ticagrelor
- tipranavir
- tofacitinib
- tolvaptan
- toremifene
- tramadol
- tranylcypromine
- trimethobenzamide
- ulipristal (post-coital contraceptive)
- valbenazine
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- venetoclax
- verapamil
- voclosporin
- vonoprazan
- voriconazole
- voxelotor
- voxilaprevir
- zanubrutinib
- zuranolone
Monitor/Modify Tx
- abiraterone acetate
- acalabrutinib
- aldesleukin
- alprazolam
- amlodipine
- avatrombopag
- baclofen intrathecal
- belzutifan
- betamethasone
- brexpiprazole
- butorphanol
- calcitriol
- carbamazepine
- chlordiazepoxide
- chlorpromazine
- cholecalciferol (vitamin D3)
- cilostazol
- citalopram
- clobazam
- clonazepam
- clorazepate
- clozapine
- crinecerfont
- cyclophosphamide
- cyclosporine
- desflurane
- dexmedetomidine
- dexmedetomidine injection
- diazepam
- digoxin
- disopyramide
- doxercalciferol
- droperidol
- esketamine
- esomeprazole
- estazolam
- eszopiclone
- ethanol (in some formulations)
- ethosuximide
- etomidate
- fexinidazole
- flibanserin
- fludrocortisone
- fluphenazine
- flurazepam
- fosphenytoin
- gabapentin
- gabapentin enacarbil
- guanfacine
- haloperidol
- hydrocortisone
- hydromorphone
- hydroxyzine
- ifosfamide
- imipramine
- isoflurane
- ketamine
- lamotrigine
- lapatinib
- levorphanol
- lorazepam
- lurasidone
- macimorelin
- methohexital
- mirtazapine
- morphine
- nalbuphine
- nelarabine
- nimodipine
- nortriptyline
- olanzapine
- omeprazole
- opicapone
- opium
- oxazepam
- oxybutynin
- oxymorphone
- pentazocine
- pentobarbital
- perampanel
- perphenazine
- phenobarbital
- phenytoin
- pregabalin
- primidone
- propofol
- quazepam
- quetiapine
- quinidine (antiarrhythmic)
- remifentanil
- remimazolam
- repaglinide
- rufinamide
- sevoflurane
- sildenafil
- sirolimus
- stiripentol
- suvorexant
- tacrolimus
- tapentadol
- temazepam
- temsirolimus
- thioridazine
- thiothixene
- tiagabine
- triazolam
- ubrogepant
- vilazodone
- vortioxetine
- warfarin
- zaleplon
- ziconotide
- zolpidem
- zonisamide
Caution Advised
- 5-HTP
- acyclovir
- adagrasib
- albendazole
- aliskiren
- allopurinol
- almotriptan
- amantadine
- aminophylline
- amiodarone
- amitriptyline
- amoxapine
- amoxicillin
- amphetamine
- ampicillin
- apalutamide
- apixaban
- apomorphine
- apraclonidine ophthalmic
- apremilast
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- asenapine
- atorvastatin
- avanafil
- axicabtagene ciloleucel
- baclofen
- belumosudil
- benzphetamine
- bortezomib
- bosentan
- brexucabtagene autoleucel
- brimonidine ophthalmic
- brimonidine topical
- brivaracetam
- bromocriptine
- brompheniramine
- budesonide
- busulfan
- cannabidiol
- cannabis
- carbinoxamine
- carisoprodol
- cefazolin
- cefepime
- cefiderocol
- ceftaroline
- ceftazidime
- ceftobiprole
- ceritinib
- cetirizine
- chamomile, German
- chlophedianol
- chlorambucil
- chloroquine
- chlorpheniramine
- chlorzoxazone
- ciltacabtagene autoleucel
- ciprofloxacin
- cisatracurium
- clemastine
- clindamycin
- clomipramine
- cocaine
- colchicine
- copanlisib
- cortisone
- cyclobenzaprine
- cycloserine
- cyproheptadine
- dantrolene
- dapsone
- darbepoetin alfa
- darifenacin
- darunavir
- dasatinib
- delafloxacin
- desipramine
- desvenlafaxine
- deutetrabenazine
- dexamethasone
- dexbrompheniramine
- dexchlorpheniramine
- dexlansoprazole
- dexmethylphenidate
- dextroamphetamine
- dichlorphenamide
- dicloxacillin
- diethylpropion
- difelikefalin
- difenoxin
- dimenhydrinate
- diphenhydramine
- diphenoxylate
- domperidone
- donepezil
- doxepin
- doxepin topical
- dronabinol
- drospirenone (hormone replacement)
- duloxetine
- efavirenz
- eletriptan
- eliglustat
- elivaldogene autotemcel
- enfortumab vedotin
- entacapone
- enzalutamide
- ephedra
- epoetin alfa
- ertapenem
- erythromycin
- escitalopram
- eslicarbazepine acetate
- ethinyl estradiol (hormone replacement)
- etoposide
- etrasimod
- etravirine
- exemestane
- felbamate
- fenfluramine
- fesoterodine
- finasteride
- fluoxetine
- fluvoxamine
- foscarnet
- foslevodopa
- fostemsavir
- frovatriptan
- futibatinib
- galantamine
- ganciclovir
- gefitinib
- gepirone
- gepotidacin
- glofitamab
- glyburide
- glycopyrrolate
- goserelin
- histrelin
- hydroxychloroquine
- hyoscyamine
- idecabtagene vicleucel
- iloperidone
- imipenem
- interferon beta 1a
- interferon beta 1b
- iohexol
- iopamidol
- isoniazid
- isotretinoin
- ivabradine
- ixabepilone
- ixazomib
- ketorolac
- lacosamide
- lansoprazole
- lasmiditan
- leuprolide
- levetiracetam
- levocarnitine
- levocetirizine
- levodopa
- levofloxacin
- levomilnacipran
- levonorgestrel (hormone replacement)
- levonorgestrel intrauterine device (contraceptive)
- lidocaine
- lidocaine topical
- linezolid
- linvoseltamab
- lisdexamfetamine
- lisocabtagene maraleucel
- lithium
- lofexidine
- lovastatin
- loxapine
- lumacaftor/ivacaftor
- magnesium citrate
- maribavir
- mavorixafor
- meclizine
- mefloquine
- melatonin
- meprobamate
- meropenem
- methamphetamine
- methocarbamol
- methotrexate
- methoxy polyethylene glycol-epoetin beta
- methsuximide
- methyldopa
- methylphenidate
- methylprednisolone
- metronidazole
- metyrapone
- metyrosine
- mexiletine
- milnacipran
- mitotane
- molindone
- mosunetuzumab
- moxifloxacin
- mycophenolate mofetil
- nafarelin
- nafcillin
- naltrexone
- naratriptan
- nintedanib
- norethindrone (hormone replacement)
- obecabtagene autoleucel
- ofloxacin
- ondansetron
- orphenadrine
- osimertinib
- oxacillin
- oxcarbazepine
- paclitaxel
- pacritinib
- paliperidone
- panobinostat
- paroxetine
- passion flower
- pazopanib
- peginterferon beta 1a
- penicillin G
- penicillin V
- pexidartinib
- phendimetrazine
- pheniramine
- phentermine
- pimozide
- piperacillin
- pitolisant
- polatuzumab vedotin
- polyethylene glycol
- polyethylene glycol/electrolytes
- pramipexole
- prednisolone
- prednisone
- procarbazine
- prochlorperazine
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- proguanil
- propafenone
- protriptyline
- pyridostigmine
- pyrilamine
- pyrimethamine
- quinidine (CYP2D6 inhibitor)
- quinine
- ramelteon
- rasagiline
- regadenoson
- regorafenib
- relugolix
- rifabutin
- risperidone
- ritlecitinib
- rivastigmine
- rizatriptan
- ropinirole
- rotigotine transdermal
- ruxolitinib
- safinamide
- scopolamine
- selegiline
- selegiline transdermal
- selinexor
- sertraline
- sirolimus albumin-bound
- sodium picosulfate
- solifenacin
- sorafenib
- sotorasib
- sparsentan
- sulfate bowel prep
- sumatriptan
- sunitinib
- teclistamab
- terbinafine
- terbutaline
- tetrabenazine
- theophylline
- tinidazole
- tisagenlecleucel
- tivozanib
- tizanidine
- tolcapone
- tolterodine
- topiramate
- trabectedin
- tranexamic acid
- trazodone
- treosulfan
- tretinoin
- triamcinolone
- trifluoperazine
- trihexyphenidyl
- trimipramine
- triprolidine
- triptorelin
- trospium
- tucatinib
- upadacitinib
- vadadustat
- valacyclovir
- valerian
- valganciclovir
- valproic acid
- vandetanib
- varenicline
- vemurafenib
- venlafaxine
- vigabatrin
- viloxazine
- vinblastine
- vincristine
- vinorelbine
- vorapaxar
- ziprasidone
- zolmitriptan
Adverse Reactions .
Serious Reactions
- drug rxn w/ eosinophilia and systemic sx
- hepatic failure
- QT shortening
- suicidality
- CNS depression
- withdrawal seizures if abrupt D/C
Common Reactions
- somnolence
- dizziness
- fatigue
- hyperkalemia
- visual disturbance
- headache
- cognitive dysfxn
- nausea
- balance disorder
- constipation
- gait disturbance
- vomiting
- diarrhea
- appetite decr.
- ALT or AST elevated
- tremor
- xerostomia
- dyspnea
- dysmenorrhea
- abdominal pain
- dyspepsia
- euphoria
- irritability
- dysgeusia
- palpitations
Safety/Monitoring .
Monitoring Parameters
s/sx depression, behavior changes, suicidality
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; possible risk of embryo-fetal death, incomplete skeletal ossification, and decr. fetal wt based on animal data at recommended human dose
Pregnancy Registry
encourage pts to enroll in North American Antiepileptic Drug Pregnancy Registry at 1-888-233-2334 or www.aedpregnancyregistry.org
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: glucuronidation, oxidation; CYP450: 2A6, 2B6, 2C19, 2E1, 3A4/5 substrate; UGT: 2B4, 2B7 substrate
Excretion: urine 87.8%, feces 5.2%; Half-life: 50-60h
Subclass: Seizure Disorders
Mechanism of Action
exact mechanism of action unknown; inhibits voltage-gated sodium channels, reducing repetitive neuronal firing; provides positive allosteric modulation of GABA ion channel
Formulary .
No Formulary Selected
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