FAQ

Answers to common questions about XCOPRI® (cenobamate tablets) CV

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ABOUT EPILEPSY

The International League Against Epilepsy considers a person to have epilepsy if they meet any of the following conditions:1

  1. At least 2 unprovoked (or reflex) seizures occurring greater than 24 hours apart
  2. One unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after 2 unprovoked seizures, occurring over the next 10 years
  3. Diagnosis of an epilepsy syndrome
Additional Epilepsy Facts

A seizure is an abnormal paroxysmal discharge of neurons.2

Additional Epilepsy Facts

There are some things that can trigger seizures in patients with epilepsy. They include sleep deprivation, stress, fever, alcohol binging, use of recreational drugs, and use of some prescribed and/or over-the-counter medications.3

Additional Epilepsy Facts

Seizures affect people differently, and there are several types of seizures. Seizures may come in three distinct phases, with a beginning, middle, and end. Some people experience an aura or other warning signs that a seizure is coming on, including dizziness, headache, nausea, or altered senses or emotions. During the middle of the seizure, some people lose consciousness or feel confused and/or experience tremors or can’t move at all, among many other possible symptoms. At the end, they may feel sleepy, scared, confused, or embarrassed, and/or they may have a headache, nausea, or weakness, to name a few symptoms.4

Additional Epilepsy Facts

Seizures usually last between a few seconds and a couple of minutes. Most seizures last between 30 seconds and 2 minutes. However, depending on the type of seizure, it can be shorter or substantially longer. A seizure that lasts longer than 5 minutes is a medical emergency.5

Additional Epilepsy Facts

Keep the person safe and call for medical help if the seizure continues for a prolonged period of time (longer than 5 minutes). After the seizure is over, stay with them or see them home safely.6

Additional Epilepsy Facts

A partial-onset seizure, also known as a focal seizure, starts in one part of the brain and may stay there or may spread. This is different from a generalized seizure, which starts in both hemispheres at the same time.7

Additional Epilepsy Facts
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CHOOSING XCOPRI AS A TREATMENT

XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.8

For additional information, please review the Full Prescribing Information for XCOPRI.

Consider XCOPRI

XCOPRI is indicated for the treatment of partial-onset seizures in adult patients, meaning 18 years and older. There are ongoing trials for the pediatric population, but safety and effectiveness in pediatric patients has not been established at this time.

See XCOPRI Full Prescribing Information.

Sample packs are available in 12.5 mg (weeks 1-2) and 25 mg (weeks 3-4).

To learn more about receiving samples of XCOPRI, connect with a sales representative.

Contact a Rep

To connect with an XCOPRI representative, please fill out a form here.

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XCOPRI STUDY DESIGN AND EFFICACY

Patients saw significant reductions in overall seizure frequency during clinical trials, with as many as 1 in 5 patients achieving ZERO SEIZURES while taking XCOPRI during the maintenance phase.8

See the Data

The top five were levetiracetam, lamotrigine, lacosamide, carbamazepine/oxcarbazepine, and topiramate.8-10

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Study 2 had a 6-week titration phase and a 12-week maintenance phase. The primary endpoint for each dose included all 18 weeks of treatment. Based on the titration schedule in that study, subjects in the 400-mg group did not reach their target dose of 400 mg until the beginning of the maintenance phase. However, there is a clear dose response (400 mg better than 200 mg) for subjects having a response of 75% to 100% during the maintenance phase.8

See Results

The trials had approximately 100 patients per arm. More than 80% of the patients were on 2+ ASMs. Due to the various different combinations that patients could have been on, there were not enough patients in the trials to make a meaningful determination.8-10

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A statistical significance in the primary endpoint was demonstrated with 100 mg. Based on the current starting dose and titration, 100 mg is reached at 6 weeks.8

See Results

Cenobamate has been shown to reduce neuronal excitability through a dual mechanism of action. Cenobamate is a positive allosteric modulator of the GABAA receptor and also inhibits the persistent sodium current.8,11

Learn More
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XCOPRI SAFETY AND TOLERABILITY

For safety information related to XCOPRI, please see the XCOPRI Full Prescribing Information.

Safety Data

XCOPRI should be used with caution, and dosage reduction may be considered in patients with mild to moderate (CLcr 30 to less than 90 mL/min) and severe (CLcr less than 30 mL/min) renal impairment. Use in patients with end-stage renal disease undergoing dialysis is not recommended.8

See XCOPRI Full Prescribing Information.

For patients with mild to moderate (5-9 points on the Child-Pugh assessment) hepatic impairment, the maximum recommended dosage is 200 mg once daily. XCOPRI is not recommended for use in patients with severe hepatic impairment.8

See XCOPRI Full Prescribing Information.

Familial QT shortening is a life-threatening, inherited heart disease.12

In a review article published in Heart Rhythm journal in 2018, which conducted a review of papers published from 2000–2017, there were 220 patients identified with Familial QT shortening.12

As per the XCOPRI Full Prescribing Information, there is no recommendation to perform an EKG prior to or during XCOPRI use.8

After the FDA and DEA review of the cenobamate New Drug Application (NDA), it was concluded that cenobamate has a relative abuse potential lower than substances in Schedule IV but greater than placebo and should be placed into Schedule V of the Controlled Substances Act.8,13

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XCOPRI DOSING AND TITRATION

XCOPRI is a once-daily pill that is titrated in 2-week intervals and is available in 6 tablet strengths.8

See the XCOPRI Full Prescribing Information for full information on how patients should take XCOPRI.

XCOPRI can be prescribed as monotherapy or adjunctive therapy.8

The top five concomitant epilepsy medications used with XCOPRI were levetiracetam, lamotrigine, lacosamide, carbamazepine/oxcarbazepine, and topiramate.8-10

Learn More

Please refer to the XCOPRI Full Prescribing Information.

Please refer to the XCOPRI Full Prescribing Information.

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DRUG-TO-DRUG INTERACTIONS

As per the XCOPRI Full Prescribing Information, because of the potential for reduced efficacy of oral contraceptives, women should use additional or alternative nonhormonal birth control while taking XCOPRI.8

XCOPRI Prescribing Information

A list of drug interactions is provided in Section 7.1 of the XCOPRI Full Prescribing Information. It is important to be aware of the potential emergence of side effects early in the XCOPRI titration with clobazam, phenytoin and phenobarbital.8

For additional information, you may contact medical information by calling 1-866-657-5574, e-mailing [email protected], or visiting the medical information website by clicking here.

Learn more about prescribing XCOPRI as an adjunctive therapy.

See Section 7.1 of XCOPRI PI
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XCOPRI ACCESS & SUPPORT

XCOPRI can be purchased at any retail pharmacy.

Nine out of ten Commercial, Medicare, and Medicaid patients have coverage.* If a prior authorization (PA) is required, ~90% of PAs are approved based solely on indication.*

*Managed Markets Insight & Technology, LLC, database as of June 2024.

Yes, we have a program called SK Life Science Navigator that may be able to provide financial support to patients meeting our Patient Assistance Program criteria. Patients can visit www.sklsinavigator.com or call 866-756-2844.

Eligible patients with commercial insurance can receive copay assistance at their pharmacy. If they are eligible for insurance, the copay assistance will automatically be applied at the pharmacy; patients do not need to enroll to be eligible.

See Resources

The following organizations and websites offer resources for finding patient support:

CURE Epilepsy

The Epilepsy Foundation

Epilepsy Alliance America

XCOPRI Patient Stories

XCOPRI YouTube Page

XCOPRI Patient Website

References: 1. Fisher R; International League Against Epilepsy. A revised definition of epilepsy. Epilepsy Foundation. April 15, 2014. Accessed October 3, 2024. https://www.epilepsy.com/stories/revised-definition-epilepsy 2. Bromfield EB, Cavazos JE, Sirven JI, eds. An Introduction to Epilepsy. American Epilepsy Society; 2006. 3. Schachter SC. Seizure triggers. Epilepsy Foundation. Accessed October 3, 2024. https://www.epilepsy.com/what-is-epilepsy/seizure-triggers 4. Schachter SC. What happens during a seizure? Epilepsy Foundation. February 4, 2022. Accessed October 3, 2024. https://www.epilepsy.com/what-is-epilepsy/understanding-seizures/what-happens-during-seizure 5. Seizures. Mayo Clinic. September 2, 2023. Accessed October 3, 2024. https://www.mayoclinic.org/diseases-conditions/seizure/symptoms-causes/syc-20365711 6. Shafer PO. Seizure first aid training and certification. Epilepsy Foundation. Accessed October 3, 2024. https://www.epilepsy.com/recognition/first-aid-resources#What-should-I-do-when-someone-has-a-seizure 7. Kiriakopoulos E. Types of seizures. Epilepsy Foundation. Accessed October 3, 2024. https://www.epilepsy.com/what-is-epilepsy/seizure-types 8. XCOPRI [package insert]. Paramus, NJ: SK Life Science, Inc. 9. Chung SS, French JA, Kowalski J, et al. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology. 2020;94(22):e2311-e2322. 10. 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;19(1):38-48. 11. Nakamura M, Cho JH, Shin H, Jang IS. Effects of cenobamate (YKP3089), a newly developed anti-epileptic drug, on voltage-gated sodium channels in rat hippocampal CA3 neurons. Eur J Pharmacol. 2019;855:175-182. 12. Bjerregaard P. Diagnosis and management of short QT syndrome. Heart Rhythm. 2018;15(8):1261-1267. 13. Data on file. SK Life Science, Inc.
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INDICATION

XCOPRI® (cenobamate tablets) CV is indicated for the treatment of partial‑onset seizures in adult patients.

Important Safety Information
and indication

CONTRAINDICATIONS
XCOPRI® is contraindicated in any patients with known hypersensitivity to the compound or any of the components of the drug product.
XCOPRI is contraindicated in patients with Familial Short QT syndrome.

Close IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION and INDICATION for XCOPRI® (cenobamate tablets) CV

CONTRAINDICATIONS

XCOPRI is contraindicated in any patients with known hypersensitivity to the compound or any of the components of the drug product.

XCOPRI is contraindicated in patients with Familial Short QT syndrome.

WARNINGS AND PRECAUTIONS

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Also known as Multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including XCOPRI. DRESS has been reported, including one fatality, when XCOPRI is titrated rapidly (weekly or faster titration). No cases of DRESS were reported in an open-label safety study of 1339 partial-onset seizure patients when XCOPRI was initiated at 12.5 mg/day and titrated every two weeks. This finding does not establish that the risk of DRESS is prevented by a slower titration; however, XCOPRI should be initiated at 12.5 mg once daily and titrated every two weeks. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement. Eosinophilia is often present. If such signs or symptoms are present, the patient should be evaluated immediately. XCOPRI should be discontinued immediately and not restarted if an alternative etiology for the signs or symptoms cannot be established.

QT Shortening: XCOPRI can cause shortening of the QT interval. Caution should be used when administering XCOPRI and other drugs that shorten the QT interval as there may be a synergistic effect on the QT interval that would increase the QT shortening risk.

Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including XCOPRI, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider.

Neurological Adverse Reactions: XCOPRI causes dose-dependent increases in the neurologic adverse reactions including, dizziness, diplopia, disturbance in gait and coordination, somnolence, and fatigue.

Prescribers should advise patients against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of XCOPRI is known.

Withdrawal of AEDs: As with all antiepileptic drugs, XCOPRI should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. But if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered.

MOST COMMON ADVERSE REACTIONS

In adult adjunctive therapy placebo-controlled clinical studies, the most common adverse reactions that occurred in XCOPRI-treated patients (incidence at least 10% and greater than placebo) were somnolence, dizziness, fatigue, diplopia, headache.

DOSING CONSIDERATIONS

Dosage adjustment of XCOPRI or other concomitant medications may be necessary.

  • Consider gradually reducing phenytoin dosages by up to 50% during initial titration.
  • Consider reducing dosages of phenobarbital and clobazam as needed when used concomitantly with XCOPRI. When XCOPRI and carbamazepine or lamotrigine are taken concomitantly, consider increasing dosages as needed of carbamazepine or lamotrigine.
  • Consider increasing dosages as needed of drugs which are CYP2B6 and CYP3A substrates and decreasing dosages as needed of drugs which are CYP2C19 substrates.
  • Effectiveness of hormonal oral contraceptives may be reduced when administered concomitantly with XCOPRI. Women should use additional or alternative non-hormonal birth control.

Dosage reduction of XCOPRI may be considered in patients with mild to moderate and severe renal impairment. XCOPRI use is not recommended in end‑stage renal disease.

The maximum recommended daily dose is 200 mg for patients with mild or moderate hepatic impairment. XCOPRI use is not recommended in patients with severe hepatic impairment

DRUG ABUSE

XCOPRI is a Schedule V controlled substance.

INDICATION

XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.

Please see full Prescribing Information.