Introducing
new
xcopri
® (cenobamate tablets) CV
Are you a
US healthcare professional?
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Xcopri access 
& resources

Downloadable tools
for your office staff

ACCESS WITH SK LIFE SCIENCE NAVIGATOR

Help your patients who are prescribed XCOPRI® (cenobamate tablets) CV get started and stay on therapy as appropriate

The SK life science navigator program may assist you and your staff with the following*:

XCOPRI HCP SK life science Navigator Identify Insurance Coverage Icon

Identifying if XCOPRI is covered by your patient’s insurance plan

XCOPRI HCP SK life science Navigator Provide Prior Authorization Icon

Providing prior authorization information for XCOPRI if it is required for the insurance plan

XCOPRI HCP SK life science Navigator Supply Free Product Icon

Supplying free product to your patients who are*:
– Initiating therapy
– Experiencing coverage delays with their insurance
– Rendered uninsured or underinsured

XCOPRI HCP SK life science Navigator Appointment Reminder Text Message Icon

Sending refill and appointment reminders to your patients via text message, if requested

Enrolling your patients is simple

Just 2 simple steps to enroll a patient in the SK life science navigator program (either via fax or through our online HCP portal that can collect electronic signatures):

  1. A healthcare provider (HCP) needs to complete the SK life science navigator program Enrollment Form, including§:
    • Patient information
    • Pharmacy insurance information
    • HCP information
    • Patient diagnosis
    • Prescription information
    • HCP signature
  2. Patients must sign the Patient Authorization section
    • Completed forms can be faxed to SK life science navigator at 877-436-4188, or submit via electronic portal

*Eligibility requirements will apply. Please visit www.SKLSINavigator.com for more information.

Program not available to hospital inpatients, long-term care patients, group medical home patients, Veterans Affairs, or the Department of Defense.

Standard text messaging rates may apply.

§If prescribing from New York, Iowa, or any state that requires e-prescribing, please complete the enrollment form and contact SK life science navigator at 866-756-2844 (866-SK-NAVIG).

XCOPRI drug-drug interactions flashcard

XCOPRI HCP Drug-Drug Interaction Flashcard Thumbnail
This downloadable resource highlights important drug-drug interactions information and the dose adjustments that may be needed when prescribing XCOPRI concomitantly with certain medications.

XCOPRI Setting Expectations Tearpad

XCOPRI Setting Expectations Tearpad Thumbnail
Part of the HCP Setting Expectations Kit, this tearpad is designed for patients to take home and for HCPs to easily educate and prepare them on what to expect when taking XCOPRI.

S.T.E.P.S.—A discussion guide for patients with epilepsy

XCOPRI HCP STEPS Discussion Guide Thumbnail

connect with an XCOPRI Representative

Want to learn more about XCOPRI and/or receive updates from SK life science?

All fields required.

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