WHAT TO EXPECT
WHEN TAKING XCOPRI

Important information about common side effects, how to take XCOPRI® (cenobamate tablets) CV, and once-daily dosing schedule.

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Real XCOPRI Patient - Mary Kate, Actor

Mary Kate, Actor, real XCOPRI patient

WHAT YOU NEED TO KNOW: COMMON SIDE EFFECTS

Before starting XCOPRI® (cenobamate tablets) CV, it’s important to discuss the potential benefits and risks with your doctor. There is a chance you may experience side effects. The most common side effects of XCOPRI include feeling sleepy and tired, dizziness, double vision, and headache.

Feeling sleepy and tired

Dizziness XCOPRI Side Effect Spiral Icon

Dizziness

Double Vision XCOPRI Side Effect Overlapping Eyes Icon

Double vision

Headache XCOPRI Side Effect Spiral on Head Icon

Headache

Managing your side effects

Keep track of any side effect you have and share it with your doctor. They can provide medical advice about side effects.

It is important to pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings, and report any to your doctor.

XCOPRI can cause serious or life-threatening side effects

Call your doctor or 911 right away if you experience reactions such as a skin rash, hives, fever, swelling of the face, eyes, lips, or tongue. Please refer to the Medication Guide and Important Safety Information for additional information.

Before starting once-daily XCOPRI

It is important to let your doctor know if you have been diagnosed with a genetic problem that affects your heart (called Familial Short QT syndrome). Do not take XCOPRI if you have Familial Short QT syndrome.

These are not all the possible side effects of XCOPRI. A full description of side effects can be found in the Medication Guide and Important Safety Information.

“Now, I am fighting for the possibility of zero seizures with XCOPRI.”

Chrissy

Mom, real XCOPRI patient

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Individual results may vary.

XCOPRI Patient Standing with Arms on Hips

How to take XCOPRI tablets:

Taken By Mouth, Once Daily' Clock Icon

BY MOUTH,
ONCE DAILY

May Be Taken With or Without Food' Apple Icon

MAY BE TAKEN WITH
OR WITHOUT FOOD

Must be Swallowed Whole with Liquid, Not Chewed or Crushed' Pill Icon

XCOPRI CAN BE TAKEN WHOLE OR CRUSHED

XCOPRI FLEXIBLE ONCE-DAILY DOSING MEANS PERSONALIZED DOSING FOR YOU

If you and your doctor decide to add XCOPRI to your regimen, you will start on the lowest dosage and increase your dosage over time until you reach a dosage that’s right for you.

  • The recommended starting dosage is 12.5 mg once daily
  • The recommended maintenance dosage is 200 mg once daily
    • In some cases, your doctor may increase your dosage if needed. However, your daily dosage should not exceed 400 mg
  • It’s important to take your medicine about the same time every day

If you have mild or moderate liver issues, your doctor will make sure you do not exceed a daily dosage of 200 mg. Use of XCOPRI in patients with severe liver issues is not recommended.

Recommended Maintenance XCOPRI (cenobamate tablets) CV Dosage Chart - Horizontal
Recommended Maintenance XCOPRI (cenobamate tablets) CV Dosage Chart - Vertical

How XCOPRI is supplied

You’ll receive convenient, monthly pill packs and detailed dosing instructions from your doctor to help you find the right dosage for you. It’s important to follow these instructions. Remember, do not stop taking XCOPRI without first talking with your doctor.

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Watch real stories from real people taking XCOPRI
INDICATION

XCOPRI® (cenobamate tablets) CV is a prescription medicine used to treat partial-onset seizures in adults.

IMPORTANT SAFETY INFORMATION

DO NOT TAKE XCOPRI IF YOU:

  • Are allergic to cenobamate or any of the other ingredients in XCOPRI.
  • Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart.

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

DO NOT TAKE XCOPRI IF YOU:
  • Are allergic to cenobamate or any of the other ingredients in XCOPRI.
  • Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart.
XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider.

QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting.

Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.

Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you.

Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider.

DISCONTINUATION:

Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

DRUG INTERACTIONS:

XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

PREGNANCY AND LACTATION:

XCOPRI may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use.

Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1‑888‑233‑2334 or go to www.aedpregnancyregistry.org.

Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI.

COMMON SIDE EFFECTS:

The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired.

These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088 or at www.fda.gov/medwatch.

DRUG ABUSE:

XCOPRI is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep XCOPRI in a safe place to prevent misuse and abuse. Selling or giving away XCOPRI may harm others and is against the law.

INDICATION:

XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older.

It is not known if XCOPRI is safe and effective in children under 18 years of age.

Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment.

Please see full Prescribing Information and Medication Guide.

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

DO NOT TAKE XCOPRI IF YOU:
  • Are allergic to cenobamate or any of the other ingredients in XCOPRI.
  • Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart.
XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider.

QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting.

Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.

Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you.

Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider.

DISCONTINUATION:

Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

DRUG INTERACTIONS:

XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

PREGNANCY AND LACTATION:

XCOPRI may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use.

Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1‑888‑233‑2334 or go to www.aedpregnancyregistry.org.

Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI.

COMMON SIDE EFFECTS:

The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired.

These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088 or at www.fda.gov/medwatch.

DRUG ABUSE:

XCOPRI is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep XCOPRI in a safe place to prevent misuse and abuse. Selling or giving away XCOPRI may harm others and is against the law.

INDICATION:

XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older.

It is not known if XCOPRI is safe and effective in children under 18 years of age.

Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment.

Please see full Prescribing Information and Medication Guide.