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Xcopri
cenobamate
Adult Dosing .
Dosage forms: TAB: 25 mg, 50 mg, 100 mg, 150 mg, 200 mg; TAB (14-day titration pack): 12.5 mg x14; TAB (28-day titration pack): 12.5 mg x14 and 25 mg x14; TAB (28-day titration pack): 50 mg x14 and 100 mg x14; TAB (28-day titration pack): 150 mg x14 and 200 mg x14
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: ALT or AST 3x ULN with bilirubin 2x ULN
- 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
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- drug reaction with eosinophilia and systemic symptoms
- hepatic failure
- hepatic injury
- QT shortening
- suicidality
- CNS depression
- withdrawal seizures if abrupt D/C
Common Reactions
- somnolence
- dizziness
- fatigue
- hyperkalemia
- visual disturbance
- headache
- cognitive dysfunction
- 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
AST/ALT, alk phos, bilirubin at baseline, then as clinically indicated; signs/symptoms of 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 patients 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: for cenobamate: glucuronidation, oxidation; CYP450: 2A6, 2B6, 2C19, 2E1, 3A4/5 substrate; UGT: 2B4, 2B7 substrate
Excretion: for cenobamate: urine 87.8%, feces 5.2%; Half-life: 50-60h
Subclass: Seizure Disorders
Mechanism of Action
for cenobamate: 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
Manufacturer/Pricing .
Manufacturer: SK Life Science, Inc.
DEA/FDA: Schedule V
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
oral tablet:
- 50 mg (30 ea): $1,060.00
- 100 mg (30 ea): $1,060.00
- 150 mg (30 ea): $1,060.00
- 200 mg (30 ea): $1,060.00
oral tablet:
- 12.5 mg/25 mg (1 package, Titration pack): $102.00
- 50 mg/100 mg (1 package, Titration pack): $1,060.00
- 150 mg/200 mg (1 package, Titration pack): $1,060.00
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