Introducing

xcopri® (cenobamate tablets) CV
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Efficacy

Discover the power of XCOPRI1

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XCOPRI was studied in adults with uncontrolled partial-onset seizures1

XCOPRI® (cenobamate tablets) CV was studied across 2 multicenter, randomized, double-blind, placebo-controlled studies in adult patients with partial-onset seizures with or without secondary generalization.1

1-to-3-concomitant-antiepileptic-drugs-fact-imageIn XCOPRI Clinical Trials, 1-3 Concomitant Antiepileptic Drugs Fact Image

concomitant antiepileptic drugs (AEDs) were not adequately controlling patients at baseline. The more frequently used AEDs were levetiracetam, lamotrigine, valproate or valproic acid, carbamazepine, oxcarbazepine, clobazam, lacosamide, and topiramate1-3

eighty-percent-xcopri-patient-graphIn XCOPRI clinical trials, eighty percent of patients were taking 2 or more concomitant AEDs.00

were taking 2 or more
concomitant AEDs1

24-years-epilepsy-calendar24 Years Epilepsy Calendar

was the approximate
mean duration of
epilepsy for patients
in the studies¹

9-seizures-per-28-days-statistic9 Seizures Per 28 Days Statistic

was the median
baseline seizure
frequency for
patients in both studies¹

XCOPRI HCP Efficacy Model Portrayal Dinner Table

XCOPRI was studied in uncontrolled patients, is indicated for the treatment of partial-onset seizures in adults, and can be used as a monotherapy or adjunctive therapy1

In a study of adult patients with partial-onset seizures taking XCOPRI:
2X greater seizure reduction with XCOPRI vs placebo1

The primary outcome: Median percentage reduction in 28-day seizure frequency

18-week-double-blind-seizure-reduction-xcopri-study-2-graph18 Week Double Blind Seizure Reduction XCOPRI Study 2 Graph 00 00 00 00

*Statistically significant compared with placebo.

Discover the possibility of ZERO seizures with XCOPRI1-3

Secondary outcome: Percentage of patients achieving seizure reductions of ≥75%, ≥90%, and 100%1,3

12-week-maintenance-phase-xcopri-zero-seizures-study-2-graph12 Week Maintenance Phase XCOPRI Zero Seizures Study 2 Graph ƒ 0 0 00 00 0 0 00 00 00 00 00 00

AS MANY AS 1 IN 5 PATIENTS EXPERIENCED ZERO SEIZURES1-3

Up to two-thirds of patients achieved ≥50% reduction
in seizure frequency with XCOPRI3

Demonstrated to be effective in multiple types of partial-onset seizures

XCOPRI demonstrated reductions in seizure frequency across multiple types of partial-onset seizures compared with placebo2,3,5

Secondary outcome: Median percentage reduction in 28-day seizure frequency in partial-onset seizure subtypes3,5

28-day-xcopri-median-seizure-reduction-percentage-study-2-chart28-Day XCOPRI Median Seizure Reduction Percentage Study 2 Chart 00 00 00 00 00 00 00 00 00 00 00 00

†Partial-onset seizures=focal seizures; simple partial=focal aware seizure; complex partial=focal impaired; secondary generalized tonic-clonic=focal to bilateral tonic-clonic.6

‡Only patients with simple partial motor seizures were included in the study.

References: 1. XCOPRI [package insert]. Paramus, NJ: SK Life Science, Inc. 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(22):e2311-e2322. 3. 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. 4. Data on file. SK Life Science, Inc. 5. 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(suppl):S1-S7. 6. Fisher RS, Cross JH, French JA, et al. Operational classification of seizure types by the International League of Epilepsy: position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017;58(5):522-530.

Important safety
information

Contraindications

XCOPRI® (cenobamate tablets) CV 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

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.

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.

For US Healthcare Professionals Only
For any medical questions or to report an adverse event, please contact
Medical Information at 1-866-657-5574.
© 2020 SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd.
PM-US-XCOP-0001 12/20