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Cenobamate

Pronunciation: SEN-oh-BAM-ate
Brand name: Xcopri
Dosage form: oral tablets (12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg)
Drug class: Carbamate anticonvulsants

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 11, 2024.

What is cenobamate?

Cenobamate is an oral, once-daily, tablet used to treat partial-onset seizures in adults. Cenobamate brand name is Xcopri. The tablets can be swallowed or crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube. 

Cenobamate works as an anticonvulsant by regulating irregular electrical brain signals. It can be used on its own to treat partial-onset seizures or can be used with other anti-seizure medications. The cenobamate mechanism of action (MOA) is thought to be inhibiting voltage-gated sodium channels and positively affects the γ-aminobutyric acid (GABAA) ion channel. Some people may have their seizures reduced to zero. Cenobamate drug class is an anticonvulsant.

Cenobamate FDA approval was granted on 21 November 2019 to be used for partial-onset seizures in adult patients. Cenobamate FDA approval was based on positive results from clinical trials (Study 013 and Study 017) that showed cenobamate effectiveness at significant reductions in seizure frequency compared to placebo.

How does cenobamate work?

Partial-onset seizures (sometimes called focal onset seizures) are caused by irregular electrical signals that start in one area of the brain and stay in that one area.  The way that cenobamate works to reduce partial-onset seizures is not fully understood but is thought to be related to regulating irregular electrical brain signals.

Is cenobamate a controlled substance?

Yes, cenobamate is a controlled substance. It is a Schedule V controlled substance, which means it does have some potential for abuse and, if abused, may cause limited physical dependence or psychological dependence.

Cenobamate side effects

Common cenobamate side effects

Common cenobamate side effects may include:

Serious cenobamate side effects

Get emergency medical help if you have signs of an allergic reaction to cenobamate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Cenobamate can cause serious or life-threatening allergic reactions that can affect your liver, blood cells, or other parts of the body. Call your doctor or get emergency medical help if you have symptoms such as:

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Cenobamate side effects (more detail)

Warnings

Drug reactions and hypersensitivity. Cenobamate can cause serious or life-threatening allergic reactions that can affect your liver, blood cells, or other parts of the body. Call your doctor or get emergency medical help if you have symptoms such as: severe weakness or muscle pain, a fever, swollen glands, unusual bruising or bleeding, swelling in your face or throat, trouble breathing, hives or a rash, yellowing of your skin or eyes, or any illness that does not get better.

Suicidal Behavior and Ideation: Some people have thoughts about suicide while taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

QT Shortening (heart rhythm issues): Use caution when administering this medicine with other drugs that shorten the QT interval.

Neurological Adverse Reactions: Monitor for sleepiness and tiredness (fatigue) and advise patients not to drive or operate machinery until they know how this medicine affects them. Concomitant use with other CNS depressants or alcohol may have additive effects. 

Do not stop using cenobamate suddenly. Follow your doctor's instructions about tapering your dose.

Contraindications

Cenobamate contraindications are if you are allergic to it, or if you have a genetic heart rhythm disorder called short QT syndrome, this means you should not take it if you have these conditions.

Before taking this medicine

Tell your doctor if you have ever had:

Some people have thoughts about suicide while taking cenobamate. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Pregnancy and contraception

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

Cenobamate can make birth control pills less effective. Ask your doctor about using a non-oral birth control to prevent pregnancy. This includes injections, implants, skin patches, vaginal rings, condom, diaphragm, cervical cap, or contraceptive sponge.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cenobamate on the baby.

Breastfeeding

It may not be safe to breastfeed while using cenobamate. Ask your doctor about any risks.

Young patients

Cenobamate is not approved for use by anyone younger than 18 years old.

Cenobamate pregnancy and breastfeeding warnings (more detail)

How should I take cenobamate?

Take cenobamate exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. 

Cenobamate tablets can be swallowed whole or crushed. 

Cenobamate may be taken with or without food. 

Do not stop using cenobamate suddenly, even if you feel fine. Stopping this medicine suddenly may cause increased seizures or unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Cenobamate dosing information

Usual Adult Cenobamate Dose for Partial-onset Seizures:

Initial dose:

Weeks 1 and 2: Take 12.5 mg orally once a day.

Cenobamate Titration dose:

Weeks 3 and 4: Take 25 mg orally once a day.

Weeks 5 and 6: Take 50 mg orally once a day.

Weeks 7 and 8: Take 100 mg orally once a day.

Weeks 9 and 10: Take 150 mg orally once a day.

Maintenance Dose (starting at week 11):

Week 11 onwards. Take 200 mg orally once a day

Maximum Dose: 400 mg orally once a day

General dosing information:

Cenobamate may be used on its own (monotherapy) to treat seizures or taken with another anti-seizure medication (adjunctive therapy).

Dosage and titration should not be exceeded because of the potential for serious adverse reactions.

Titration to the maximum dose should be accomplished in increments of 50 mg/day every 2 weeks; the decision to increase the dose above the maintenance dose should be based on clinical response and tolerability.

Detailed Cenobamate dosage information

gabapentin, clonazepam, lamotrigine, pregabalin, topiramate, diazepam

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking cenobamate?

Cenobamate may cause blurred vision and may impair your reactions. You should avoid driving or participating in hazardous activities until you know how this medicine will affect you.

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

What other drugs will affect cenobamate?

Other drugs may affect cenobamate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor, pharmacist or other healthcare professionals about all your current medicines and any medicine you start or stop using.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. 

Using cenobamate with other drugs that make you dizzy or drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety.

Cenobamate may cause your birth control medicine to be less effective. Women should use additional or alternative non-hormonal birth control.

Examples of medications that have important drug interactions with cenobamate include lamotrigine (Lamictal), phenytoin, phenobarbital, clobazam, carbamazepine, CYP2B6 Substrates, CYP3A Substrates, CYP2C19 Substrates.

Not all possible interactions are listed here, use the link below to check for other cenobamate drug interactions.

Cenobamate drug interactions (more detail)

Cenobamate Package Insert 

Review the Cenobamate Package Insert (Xcopri Package Insert) for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Cenobamate Prescribing Information (PI) or Cenobamate FDA label.

How should I store Xcopri?

Ingredients

Active ingredient: cenobamate

Xcopri Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

25 mg and 100 mg tablets: FD&C Blue #2/indigo carmine aluminum lake, iron oxide red, iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

50 mg tablets: iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

150 mg and 200 mg tablets: iron oxide red, iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

Manufacturer

Xcopri by SK Life Science, Inc., Paramus, NJ 07652 

Frequently asked questions

References

  1. Xcopri Package Insert

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer