section name header

Introduction

AHFS Class:

Generic Name(s):

Cenobamate, a tetrazole alkyl carbamate derivative, is an anticonvulsant.1,2,4,6,7,8,9

Uses

Partial Seizures

Cenobamate is used in the management of partial-onset seizures in adults.1,2,4,6,7,8,9

Efficacy of cenobamate for the treatment of partial-onset seizures was established in 2 multicenter, randomized, double-blind, placebo-controlled studies of similar design in adults with refractory partial-onset seizures (with or without secondary generalization) who were not adequately controlled with 1-3 anticonvulsants.1,2,4 Patients taking phenytoin, phenobarbital, vigabatrin, felbamate, or diazepam were excluded from the studies.1,2,4,8 The studies consisted of an 8-week baseline period followed by a 6-week titration period and a maintenance treatment period of 6 weeks (Study 1) or 12 weeks (Study 2); patients who experienced at least 3 or 4 partial-onset seizures per 28 days, with no seizure-free period exceeding 3-4 weeks during the baseline period were randomized to the double-blind treatment portion of these studies.1,2,4 Patients in these studies had a mean duration of epilepsy of approximately 24 years and a median baseline seizure frequency of 8.5 seizures per 28 days; more than 80% of patients were taking 2 or more concomitantly administered anticonvulsants with or without concurrent vagal nerve stimulation.1 The primary efficacy end point in both studies was the percent change from baseline in seizure frequency per 28 days during the treatment period.1,2,4

In Study 1, patients were randomized to receive cenobamate (at an initial daily dosage of 50 mg, which was a higher starting dosage than currently recommended) or placebo; the daily dosage of cenobamate was increased by 50 mg every 2 weeks until the target dosage of 200 mg daily was achieved.1,2 Treatment with cenobamate was associated with a substantial reduction in seizure frequency per 28 days from baseline compared with placebo (median reduction of 55.6 versus 21.5%).1,2 Seizure freedom during the maintenance treatment phase was achieved in 28.3 or 8.8% of patients receiving cenobamate or placebo, respectively.2 In a long-term, open label extension of Study 1, cenobamate (50-400 mg daily based on individual tolerability and response) was generally well-tolerated in patients receiving the drug for up to 7.8 years as adjunctive therapy for treatment-resistant partial-onset seizures; approximately 50% of patients were able to discontinue and remain off of at least one of their other concomitant anticonvulsant drugs.9

In Study 2, patients were randomized to receive cenobamate (100, 200, or 400 mg daily) or placebo; cenobamate was initiated at a dosage of 50 mg, which was a higher starting dosage than currently recommended; the daily dosage of cenobamate was increased by 50 mg every week (a more rapid titration than currently recommended) until a target daily dosage of 100 or 200 mg was reached, and further increased by 100 mg/day every week in patients randomized to a dosage of 400 mg daily.1,4 Treatment with all dosages of cenobamate resulted in substantial reductions in seizure frequency per 28 days compared with placebo; the median reduction in seizure frequency from baseline was 55, 55, or 36% in patients receiving daily cenobamate dosages of 400, 200, or 100 mg, respectively, compared with a reduction of 24% in patients receiving placebo.1,4 Seizure freedom during the maintenance treatment phase was achieved in 21, 11, or 4% of patients randomized to daily cenobamate dosages of 400, 200, or 100 mg, respectively, and in 1% of patients receiving placebo.1,4

Dosage and Administration

[Section Outline]

General !!navigator!!

Patient Monitoring

Other General Considerations

Administration !!navigator!!

Administer cenobamate tablets orally once daily at any time without regard to food.1

Swallow the tablets whole with liquid and do not crush or chew.1

Dosage !!navigator!!

The recommended initial dosage of cenobamate for the management of partial-onset seizures in adults is 12.5 mg once daily for the first 2 weeks; dosage should be titrated to the recommended dosage of 200 mg once daily according to the manufacturer's recommended titration schedule (see Table 1).1 If needed, dosage may be further increased by increments of 50 mg once daily every 2 weeks up to a maximum dosage of 400 mg once daily based on clinical response and tolerability.1 The recommended titration schedule should not be exceeded because of the potential for serious adverse effects.1

Table 1. Recommended Dosage Titration Schedule for Cenobamate1

Week

Dosage

Weeks 1 and 2

12.5 mg once daily

Weeks 3 and 4

25 mg once daily

Weeks 5 and 6

50 mg once daily

Weeks 7 and 8

100 mg once daily

Weeks 9 and 10

150 mg once daily

Week 11 and thereafter

200 mg once daily

If therapy is discontinued, dosage should be reduced gradually over a period of at least 2 weeks unless safety concerns require abrupt withdrawal.1

Special Populations !!navigator!!

Hepatic Impairment

In patients with mild or moderate hepatic impairment (Child-Pugh class A or B), the manufacturer recommends a maximum cenobamate dosage of 200 mg once daily.1 Use of cenobamate is not recommended in patients with severe hepatic impairment.1

Renal Impairment

Use cenobamate with caution and consider dosage reduction in patients with mild to moderate (creatinine clearance 30 to <90 mL/minute) or severe (creatinine clearance <30 mL/minute) renal impairment.1

Geriatric Patients

Manufacturer recommends cautious dosage selection (usually starting at the low end of the dosage range) in geriatric patients.1

Cautions

[Section Outline]

Contraindications !!navigator!!

Warnings/Precautions !!navigator!!

Sensitivity Reactions

Multi-organ Hypersensitivity

Multi-organ hypersensitivity (also known as drug reaction with eosinophilia and systemic symptoms [DRESS]), a potentially fatal or life-threatening reaction, has been reported with some anticonvulsant drugs, including cenobamate.1 Multi-organ hypersensitivity, including one fatality, has occurred in patients receiving cenobamate when the drug was titrated rapidly (weekly or faster).1 The clinical presentation is variable, but typically includes fever, rash, lymphadenopathy, and/or facial swelling associated with other organ system involvement such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis; eosinophilia is often present.1 Signs and symptoms associated with other organ systems also may occur.1

No cases of multi-organ hypersensitivity were reported in an open-label safety study in 1339 patients with partial-onset seizures who received cenobamate at an initial dosage of 12.5 mg daily followed by titration every 2 weeks.1,6 Although it is not known whether slower titration can prevent such a reaction, the manufacturer recommends that cenobamate dosage be initiated at a low dosage and titrated every 2 weeks.1,7

Early manifestations of multi-organ hypersensitivity (e.g., fever, lymphadenopathy) may be present even without evidence of rash.1 If any manifestations of a multi-organ hypersensitivity reaction occur, evaluate patients immediately; if an alternative cause cannot be identified, permanently discontinue the drug.1

Shortening of QT Interval

Shortening of the QT interval has been reported in patients receiving cenobamate.1 In a placebo-controlled trial evaluating the drug's effects on the QT interval in healthy subjects, a higher percentage of cenobamate-treated individuals (31% at 200 mg daily and 66% at 500 mg daily) had QT shortening of >20 msec compared with those receiving placebo (6-17%).1 Reductions in QT interval to <300 msec were not observed in the formal QT-interval studies with cenobamate dosages up to 500 mg daily.1

Familial short QT syndrome is associated with an increased risk of sudden death and ventricular arrhythmias, particularly ventricular fibrillation; such events are thought to occur primarily when the corrected QT (QTc) interval falls below 300 msec.1

The manufacturer states that patients with familial short QT syndrome should not be treated with cenobamate.1 Caution is recommended when administering cenobamate with other drugs that shorten the QT interval.1

Suicidality Risk

An increased risk of suicidality (suicidal behavior or ideation) was observed in an analysis of 199 studies using various anticonvulsants compared with placebo.1 The analysis of suicidality reports from placebo-controlled studies involving 11 anticonvulsants (carbamazepine, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, valproate, and zonisamide) in patients with epilepsy, psychiatric disorders (e.g., bipolar disorder, depression, anxiety), and other conditions (e.g., migraine, neuropathic pain) found that patients receiving anticonvulsants had approximately twice the risk of suicidal behavior or ideation (0.43%) compared with patients receiving placebo (0.24%).1,3 This increased suicidality risk was observed as early as 1 week after beginning therapy and continued through 24 weeks.1,3 Although patients treated with an anticonvulsant for epilepsy, psychiatric disorders, and other conditions were all found to have an increased suicidality risk compared with those receiving placebo, the relative suicidality risk was higher for patients with epilepsy compared with those receiving anticonvulsants for other conditions.1,3

Clinicians should inform patients, their families, and caregivers of the potential for an increased risk of suicidality with anticonvulsant therapy; closely monitor all patients currently receiving or beginning therapy with any anticonvulsant for the emergence or worsening of suicidal thoughts or behavior or depression.1

Clinicians who prescribe cenobamate or any other anticonvulsant should balance the risk of suicidality with the risk of untreated illness.1 Epilepsy and many other illnesses for which anticonvulsants are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.1 If suicidal thoughts or behavior emerge during anticonvulsant therapy, consider whether these symptoms may be related to the illness being treated.1

Neurologic Effects

Cenobamate can cause a variety of adverse neurologic effects.1

Dose-dependent adverse reactions related to somnolence and fatigue (e.g., somnolence, fatigue, asthenia, malaise, hypersomnia, sedation, and lethargy) have been reported.1 In the principal efficacy studies, at least one of these adverse reactions was reported in 31, 36, or 57% of patients who received cenobamate daily dosages of 100, 200, or 400 mg, respectively, compared with 19% of patients who received placebo.1

Dose-dependent adverse reactions related to dizziness and disturbance in gait and coordination (e.g., dizziness, vertigo, balance disorder, ataxia, nystagmus, gait disturbance, and abnormal coordination) were observed in the principal efficacy studies; at least one of these adverse reactions was reported in 21, 31, or 52% of patients who received cenobamate daily dosages of 100, 200, or 400 mg, respectively, compared with 18% of patients who received placebo.1

Cognitive dysfunction (e.g., memory impairment, disturbance in attention, amnesia, confusional state, aphasia, speech disorder, slowness of thought, disorientation, and psychomotor retardation) has been reported in patients receiving cenobamate.1 In the principal efficacy studies, cognitive dysfunction was reported in 6, 6, or 9% of patients who received daily cenobamate dosages of 100, 200, or 400 mg, respectively, compared with 2% of patients who received placebo.1

Monitor patients for adverse neurologic effects and advise them not to drive or operate machinery until the effects of the drug are known.1 Carefully observe patients for signs of CNS depression when cenobamate is used with other drugs with sedative properties because of potential additive effects.1

Ophthalmologic Effects

Cenobamate can cause adverse ophthalmologic effects including diplopia, blurred vision, and impaired vision.1 In the principal efficacy studies, adverse visual reactions were reported in 9, 9, or 18% of patients who received daily cenobamate dosages of 100, 200, or 400 mg, respectively, compared with 2% of patients who received placebo.1

Discontinuance of Therapy

As with most anticonvulsant agents, there is a potential for increased seizure frequency and status epilepticus when cenobamate therapy is withdrawn abruptly.1 Reduce the dosage of cenobamate gradually over a period of at least 2 weeks and avoid abrupt discontinuance of the drug when discontinuing therapy.1 However, the manufacturer states that prompt withdrawal may be considered if discontinuance of therapy is necessary because of serious adverse effects.1

Abuse Potential and Dependence

Cenobamate is subject to control as a schedule V (C-V) drug.1 In an abuse-potential study, euphoric effects were reported more frequently following a single 400-mg dose of cenobamate (8%) than with placebo (0%).1 In phase 2 and 3 studies in subjects with epilepsy, euphoric mood, confusional state, or sedation occurred in 0.5-2.5% of subjects receiving cenobamate.1

Clinical studies in healthy subjects indicate that cenobamate may cause physical dependence and a withdrawal syndrome characterized by insomnia, decreased appetite, depressed mood, tremor, and amnesia.1 Cenobamate therapy should be withdrawn gradually.1

Specific Populations

Pregnancy

There are no adequate data in humans to determine if there is any risk associated with the use of cenobamate during pregnancy.1 In animal studies, cenobamate produced developmental toxicity (i.e., increased embryofetal mortality, decreased fetal and offspring body weight, neurobehavioral and reproductive impairment in offspring) when given orally to pregnant rats and rabbits.1 These effects were observed at dosages associated with clinically relevant plasma exposures.1

Women who are pregnant while receiving cenobamate should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 or [Web].1

Females and Males of Reproductive Potential

Females of reproductive potential who are receiving oral contraceptives should use additional or alternative nonhormonal birth control.1

Lactation

It is not known whether cenobamate is distributed into milk, affects milk production, or affects the breast-fed infant.1

Consider the benefits of breast-feeding along with the importance of cenobamate to the woman and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.1

Pediatric Use

Safety and efficacy in pediatric patients have not been established.1

Geriatric Use

Clinical studies of cenobamate did not include sufficient numbers of geriatric patients to determine whether they respond differently than younger patients.1 The manufacturer states to consider the greater frequency of decreased hepatic, renal, and/or cardiac function, and other concomitant medical conditions and drug therapy in this population.1

Hepatic Impairment

Cenobamate undergoes hepatic metabolism.1 Individuals with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment had 2.1- or 2.3-fold higher exposure, respectively, compared with healthy individuals following a single 200-mg dose of the drug.1 Use cenobamate with caution in patients with mild to moderate (Child-Pugh class A or B) hepatic impairment.1 The maximum recommended dosage in such patients is 200 mg once daily; consider additional dosage reduction.1

The effect of severe hepatic impairment on cenobamate pharmacokinetics has not been studied.1 Use of cenobamate in patients with severe hepatic impairment is not recommended.1

Renal Impairment

Cenobamate AUC was 1.4-fold to 1.5-fold higher in subjects with mild (creatinine clearance 60 to <90 mL/minute) or moderate (creatinine clearance 30 to <60 mL/minute) renal impairment following a single oral 200-mg dose of cenobamate compared to healthy individuals.1 Exposure to cenobamate did not change significantly compared to healthy individuals following a single oral 100-mg dose in subjects with severe (creatinine clearance <30 mL/minute) renal impairment.1 Use cenobamate with caution and consider dosage reduction in patients with mild to moderate (creatinine clearance 30 to <90 mL/minute) or severe (creatinine clearance <30 mL/minute) renal impairment.1

The effect of hemodialysis on cenobamate pharmacokinetics has not been studied.1 Use of cenobamate in patients with end-stage renal disease undergoing dialysis is not recommended.1

Common Adverse Effects !!navigator!!

Adverse reactions occurring in 10% or more of patients receiving oral cenobamate as adjunctive therapy in controlled clinical trials for partial-onset seizures and reported more frequently than with placebo include somnolence,1,2,4 dizziness,1,2,4 fatigue,1,2,4 diplopia,1,4 and headache.1,2,4

Drug Interactions

[Section Outline]

Cenobamate is extensively metabolized by glucuronidation via uridine 5'-diphospho-glucuronosyltransferase (UGT) isoenzyme 2B7 and to a lesser extent by UGT2B4.1,5 Cenobamate also is metabolized by cytochrome P-450 (CYP) isoenzymes 2E1, 2A6, and 2B6, and to a lesser extent by CYP2C19 and CYP3A4/5.1,5

In vitro, cenobamate inhibits CYP isoenzymes 2B6, 2C19, and 3A, but does not inhibit CYP1A2, CYP2C8, CYP2C9, or CYP2D6.1 The drug induces CYP2B6, CYP2C8, and CYP3A4, but does not induce CYP1A2, CYP2C9, or CYP2C19.1

Cenobamate is not a substrate of the efflux transporter P-glycoprotein (P-gp).1,5 Cenobamate also is not a substrate of breast cancer resistance protein (BCRP), multidrug and toxin extrusion transporters (MATE) 1 or MATE2/K, organic ion transporters (OAT) 1 and OAT3, or organic cation transporter (OCT) 2.1,5 The drug does not inhibit P-gp, OAT1, OAT3, OCT1, OCT2, organic anion transport proteins (OATP) 1B1 and OATP1B3, or bile salt extrusion protein (BSEP).1

Drugs Metabolized by Hepatic Microsomal Enzymes !!navigator!!

CYP2B6 and CYP3A Substrates

Concomitant use of cenobamate with drugs that are metabolized by CYP2B6 (e.g., bupropion) or CYP3A (e.g., midazolam) may decrease plasma concentrations of the substrate drug, potentially resulting in reduced efficacy.1 Consider an increase in dosage of the substrate drug as needed if reduced efficacy is observed.1

CYP2C19 Substrates

Concomitant use of cenobamate with drugs that are metabolized by CYP2C19 (e.g., omeprazole) may increase plasma concentrations of the substrate drug, potentially increasing the risk of adverse reactions.1 A decrease in dosage of the substrate drug should be considered as clinically appropriate if adverse reactions are observed.1

Drugs that Shorten QT Interval !!navigator!!

A synergistic effect on the QT interval may occur when cenobamate is administered with other drugs (e.g., lamotrigine, primidone, rufinamide) that shorten the QT interval.1,7 Use caution when administering cenobamate concomitantly with other drugs that shorten the QT interval.1

Alcohol !!navigator!!

Concomitant use of cenobamate with alcohol may increase the risk of adverse neurologic effects, including sedation and somnolence.1 (See CNS Depressants under Drug Interactions.)

No clinically important effects on the pharmacokinetics of cenobamate or alcohol were observed when the drugs were administered concomitantly.1

Anticonvulsants !!navigator!!

Carbamazepine

When multiple doses of cenobamate 200 mg once daily were administered concomitantly with carbamazepine, peak plasma concentration and AUC of carbamazepine each decreased by 23%.1 Because of the potential for reduced efficacy, increase dosage of carbamazepine as needed when used concomitantly with cenobamate.1

Clobazam

Concomitant use of cenobamate and clobazam can increase the plasma concentrations of desmethylclobazam, the active metabolite of clobazam.1 Because of the potential for an increased risk of adverse reactions, consider dosage reduction of clobazam during concomitant use with cenobamate.1

Lacosamide

No clinically important effects on the pharmacokinetics of lacosamide were observed when the drug was administered concomitantly with cenobamate.1

Lamotrigine

Based on population pharmacokinetic analyses, lamotrigine concentrations are expected to decrease by 21-52% during treatment with cenobamate at dosages of 100-400 mg daily.1 Because of the potential for reduced efficacy, increase dosage of lamotrigine as needed during concomitant use with cenobamate.1

Levetiracetam

No clinically important effects on the pharmacokinetics of levetiracetam were observed when the drug was administered concomitantly with cenobamate.1

Based on population pharmacokinetic analyses, levetiracetam concentrations are expected to decrease by 4-13% during treatment with cenobamate at dosages of 100-400 mg daily; this decrease is not expected to be clinically important.1

Oxcarbazepine

Clinically important interaction unlikely.1

Phenobarbital

When multiple doses of cenobamate 200 mg once daily were administered concomitantly with phenobarbital, increases in phenobarbital peak plasma concentration and AUC of 34 and 37%, respectively, were observed.1 Because of the potential for an increased risk of adverse reactions, consider dosage reduction of phenobarbital as clinically appropriate during concomitant use with cenobamate.1

Phenytoin

When multiple doses of cenobamate 200 mg once daily were administered concomitantly with phenytoin, increases in phenytoin peak plasma concentration and AUC of 70 and 84%, respectively, were observed.1 Because of a potential twofold increase in phenytoin concentrations, gradually reduce phenytoin dosage by up to 50% as cenobamate is being titrated.1

During concomitant administration of phenytoin, a decrease in plasma cenobamate multiple-dose exposure of 27-28% was observed.1

Valproic Acid

No clinically important effects on the pharmacokinetics of valproic acid were observed when the drug was administered concomitantly with cenobamate.1

Bupropion !!navigator!!

When multiple doses of cenobamate 200 mg once daily were administered concomitantly with bupropion (CYP2B6 substrate), decreases in total bupropion peak plasma concentration and AUC of 23 and 39%, respectively, were observed.1 Increase dosage of bupropion as needed when these drugs are used concomitantly.1

CNS Depressants !!navigator!!

Concomitant use of cenobamate with other CNS depressants, including alcohol, may increase the risk of adverse neurologic effects, including sedation and somnolence.1 Patients receiving cenobamate and other CNS depressants concomitantly should be monitored carefully for somnolence and sedation.1

Midazolam !!navigator!!

When multiple doses of cenobamate 200 mg once daily were administered concomitantly with midazolam (CYP3A substrate), decreases in midazolam peak plasma concentration and AUC of 61 and 72%, respectively, were observed.1 Increase dosage of midazolam as needed when these drugs are used concomitantly.1

Omeprazole !!navigator!!

When multiple doses of cenobamate 200 mg once daily were administered concomitantly with omeprazole (CYP2C19 substrate), increases in omeprazole peak plasma concentration and AUC of 83 and 107%, respectively, were observed.1 Decrease dosage of omeprazole as clinically appropriate if adverse effects occur when these drugs are used concomitantly.1

Oral Contraceptives !!navigator!!

Cenobamate may decrease plasma concentrations of oral contraceptives, potentially reducing their efficacy.1 Women taking oral contraceptives should use additional or alternative nonhormonal contraception during cenobamate therapy.1

Warfarin !!navigator!!

No clinically important effects on the pharmacokinetics of warfarin (CYP2C9 substrate) were observed when the drug was administered concomitantly with cenobamate.1

Other Information

Description

Cenobamate, a tetrazole alkyl carbamate derivative, is an anticonvulsant.1,2,4,6,7,8,9 The precise mechanism by which cenobamate exerts its therapeutic effects in patients with partial-onset seizures is unknown.1,2,7,8 Cenobamate has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents.1,2,4,7,8 In addition, the drug is a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.1,7,8

Cenobamate AUC increases in a greater than dose-proportional manner following single oral doses of 5-750 mg; however, peak plasma concentrations increase in a dose-proportional manner.1,5 Steady-state plasma concentrations are attained following approximately 2 weeks of daily dosing.1,5 At least 88% of cenobamate is absorbed following oral administration, with median time to peak plasma concentrations ranging from 1-4 hours.1,5 Administration with a high-fat meal does not affect pharmacokinetics of the drug.1 Cenobamate is 60% bound to plasma proteins (primarily albumin); protein binding is independent of concentration.1,5 Cenobamate is extensively metabolized by glucuronidation via uridine 5'-diphospho-glucuronyltransferase (UGT) isoenzyme 2B7 and to a lesser extent by UGT2B4.1,5 Cenobamate also is metabolized by cytochrome P-450 (CYP) isoenzymes 2E1, 2A6, and 2B6, and to a lesser extent by CYP2C19 and CYP3A4/5.1,5 Following administration of radiolabeled cenobamate, approximately 93% of the total radioactive dose was recovered in urine (87.8%) and feces (5.2%); more than 50% of the radioactivity was excreted within 72 hours of dosing.1 The apparent terminal half-life of cenobamate is 50-60 hours.1,5 Pharmacokinetics of the drug are not affected by age, sex, or race/ethnicity.1,5

Advice to Patients

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Cenobamate is subject to control under the Federal Controlled Substances Act of 1970 as a schedule V (C-V) drug.1

Cenobamate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Kit

14 tablets, uncoated cenobamate 12.5 mg

14 tablets, film-coated cenobamate 25 mg

Xcopri® 28-Day Titration Blister Pack

SK Life Science

14 tablets, film-coated cenobamate 50 mg

14 tablets, film-coated cenobamate 100 mg

Xcopri® 28-Day Titration Blister Pack

SK Life Science

14 tablets, film-coated cenobamate 150 mg

14 tablets, film-coated cenobamate 200 mg

Xcopri® 28-Day Titration Blister Pack

SK Life Science

28 tablets, film-coated cenobamate 100 mg

28 tablets, film-coated cenobamate 150 mg

Xcopri® 28-Day Maintenance Blister Pack

SK Life Science

28 tablets, film-coated cenobamate 150 mg

28 tablets, film-coated cenobamate 200 mg

Xcopri® 28-Day Maintenance Blister Pack

SK Life Science

Tablets, film-coated

50 mg

Xcopri®

SK Life Science

100 mg

Xcopri®

SK Life Science

150 mg

Xcopri®

SK Life Science

200 mg

Xcopri®

SK Life Science

Copyright

AHFS® Drug Information. © Copyright, 1959-2024, Selected Revisions June 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.

References

1. SK Life Science, Inc. Xcopri® (cenobamate) tablets prescribing information. Paramus, NJ; 2021 Apr.

2. Chung SS, French JA, Kowalski J et al. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology . 2020; 94:e2311-22. [PubMed 32409485]

3. US Food and Drug Administration. Statistical Review and Evaluation: Antiepileptic Drugs and Suicidality. Rockville, MD; 2008 May 23. From the FDA website. [Web]

4. Krauss GL, Klein P, Brandt C et al. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol . 2020; 15:38-48. [PubMed 31734103]

5. Vernillet L, Greene SA, Kamin M. Pharmacokinetics of cenobamate: results from single and multiple oral ascending-dose studies in healthy subjects. Clin Pharmacol Drug Dev . 2020; 9:428-443. [PubMed 32087001]

6. Sperling MR, Klein P, Aboumatar S et al. Cenobamate (YKP3089) as adjunctive treatment for uncontrolled focal seizures in a large, phase 3, multicenter, open-label safety study. Epilepsia . 2020; 61:1099-1108. [PubMed 32396252]

7. Anon. Cenobamate (Xcopri) for focal seizures. Med Lett Drugs Ther . 2020; 62:134-6. [PubMed 32970044]

8. Buckley CT, Waters OR, DeMaagd G. Cenobamate: a new adjunctive agent for drug-resistant focal onset epilepsy. Ann Pharmacother . 2021; 55:318-329. [PubMed 32623899]

9. French JA, Chung SS, Krauss GL et al. Long-term safety of adjunctive cenobamate in patients with uncontrolled focal seizures: open-label extension of a randomized clinical study. Epilepsia . 2021; 62:2142-2150 [PubMed 34254673]