UNCONTROLLED EPILEPSY

Did you know? For nearly 30 years,
the rate of seizure freedom has remained the same, even with new antiseizure medications (ASMs) coming to market1,2*

XCOPRI Epilepsy Patient Sauteing FruitXCOPRI Epilepsy Patient Sauteing Fruit

RATES OF ZERO SEIZURES BY DECADE OF APPROVAL FOR A RANGE OF ASMs3†

1990-19994,5

2.1%-8.7%

vs 0%-2.2% with placebo

2000-20096,7

2.2%-7.4%

vs 0.8%-1.2% with placebo

2010-20198-10

2.0%-8.2%

vs 0%-2% with placebo

*Seizure freedom was defined as a patient experiencing no seizures for the previous 12 months or longer.
†Data from pivotal trials.

Epilepsy is not as controlled as you may think

HEAR FROM DR SELIM R. BENBADIS, MD ON THE DANGERS OF UNCONTROLLED EPILEPSY

Why seizure freedom
must remain the goal

In this video, Dr Benbadis, MD discusses why despite one-third of epilepsy patients remaining drug-resistant, his goal is always to aim for seizure freedom, and thus, the importance of trying different treatment options with these patients.

Prior to the 1990s, there was little information on seizure
freedom rates with ASMs used as add-on therapy—and even
less information about how these rates were determined3

About 60% of people with epilepsy have partial-onset seizures—
many adults with epilepsy continue to have seizures1,11-13

Silhouettes Icon Representing 3,000,000 US Adults with Active Epilepsy
0,000,000

US adults

report having active epilepsy,*
according to the Centers for Disease
Control and Prevention11

NEARLY

00

still experience seizures
despite the use of ASMs12

*Active epilepsy was defined as having self-reported doctor-diagnosed epilepsy,
either under treatment or with seizure activity in the past 12 months.11

References: 1. Chen Z, Brodie MJ, Liew D, Kwan P. Treatment outcomes in patients with newly diagnosed epilepsy treated with established and new antiepileptic drugs: a 30-year longitudinal cohort study. JAMA Neurol. 2018;75(3):279-286. 2. Chen Z, Brodie MJ, Liew D, Kwan P. Unchanged treatment outcomes in patients with newly diagnosed epilepsy treatment with established and new antiepileptic drugs: a 30-year longitudinal cohort study. JAMA Neurol. 2017. doi:10.1001/jamaneurol.2017.3949. 3. Halford JJ, Edwards JC. Seizure freedom as an outcome in epilepsy treatment clinical trials. Acta Neurol Scand. 2020;142(2):91-107. 4. Keppra [package insert]. Smyrna, GA: UCB, Inc; 2020. 5. Topamax [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2009. 6. Vimpat [package insert]. Smyrna, GA: UCB, Inc; 2021. 7. Sabril [package insert]. Deerfield, IL: Lundbeck; 2009. 8. Fycompa [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2021. 9. Aptiom [package insert]. Marlborough, MA: Sunovion Pharmaceuticals, Inc; 2019. 10. Potiga [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2011. 11. Zack MM, Kobau R. National and state estimates of the numbers of adults and children with active epilepsy—United States, 2015. MMWR Morb Mortal Wkly Rep. 2017;66(31):821-825. 12. Tian N, Boring M, Kobau R, Zack MM, Croft JB. Active epilepsy and seizure control in adults—United States, 2013 and 2015. MMWR Morb Mortal Wkly Rep. 2018;67(15):437-442. 13. Hauser WA, Annegers JF, Kurland LT. Prevalence of epilepsy in Rochester, Minnesota: 1940-1980. Epilepsia. 1991;32(4):429-445.

REDEFINING TREATMENT OPTIONS

Just one seizure can make
an impact on patients’ lives

XCOPRI Epilepsy Patient Opening Car DoorXCOPRI Epilepsy Patient Opening Car Door

WHEN PATIENTS CONTINUE TO HAVE SEIZURES, THEY ARE1*:

6X

more likely to
have depression

4.5X

more likely to be
prevented from driving

3X

more likely to have
poor health and to experience limitations in employment and life

2X

more likely to have limits in education

Patients with uncontrolled seizures have an increased risk of SUDEP2†

HEAR FROM DR SELIM R. BENBADIS, MD ON THE NEED FOR THE SUDEP CONVERSATION

The risk of complacency:
Talking to patients about SUDEP

In this video, hear Dr Benbadis, MD speak to the importance of fighting complacency in drug-resistant patients, and why discussing the risk of SUDEP with patients who continue to face uncontrolled seizures can be a critical conversation to have.

Discover
once-daily XCOPRI1

See Efficacy
*Based on data that compared patients who had ≥1 seizure in the past 5 years with those who experienced no seizures in the past 5 years.
†Based on data that compared patients who had ≥1 seizure in the previous year with those who had zero seizures.
 SUDEP=sudden unexpected death in epilepsy.
References: 1. Josephson CB, Patten SB, Bulloch A, et al. The impact of seizures on epilepsy outcomes: a national, community-based survey. Epilepsia. 2017;58(5):764-771. 2. Nilsson L, Farahmand BY, Persson P-G, Thiblin I, Tomson T. Risk factors for sudden unexpected death in epilepsy: a case‑control study. Lancet. 1999;353(9156):888-893.
XCOPRI Epilepsy Patient Removing Clothes from Washer

PM-US-XCOP-0862

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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.

For US Healthcare Professionals Only
For US Healthcare Professionals Only
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.