Pronunciation:

sen-oh-BAM-ate

Brand Names:

• XCOPRI

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Anticonvulsant

Chemical—

Carbamate

Uses of This Medicine:

Cenobamate is used to control partial-onset seizures (convulsions) in the treatment of epilepsy.

Cenobamate belongs to a class of medicines called anticonvulsants. It acts in the brain to prevent seizures. However, this medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of cenobamate in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of cenobamate have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving cenobamate.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Mavacamten

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Atazanavir
• Atogepant
• Avacopan
• Avapritinib
• Belzutifan
• Buprenorphine
• Capivasertib
• Capmatinib
• Citalopram
• Clarithromycin
• Codeine
• Cyclosporine
• Daridorexant
• Desogestrel
• Dienogest
• Drospirenone
• Duvelisib
• Elacestrant
• Encorafenib
• Entrectinib
• Erdafitinib
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Fedratinib
• Fexinidazole
• Finerenone
• Fosphenytoin
• Fruquintinib
• Gestodene
• Glasdegib
• Ibrexafungerp
• Infigratinib
• Lamotrigine
• Larotrectinib
• Lenacapavir
• Leniolisib
• Levonorgestrel
• Lorlatinib
• Lumateperone
• Medroxyprogesterone
• Mestranol
• Mitapivat
• Mobocertinib
• Neratinib
• Nirogacestat
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Oliceridine
• Olutasidenib
• Omaveloxolone
• Oxycodone
• Pacritinib
• Palovarotene
• Pemigatinib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pirtobrutinib
• Pralsetinib
• Praziquantel
• Primidone
• Quizartinib
• Repotrectinib
• Rimegepant
• Ripretinib
• Segesterone
• Selpercatinib
• Selumetinib
• Sildenafil
• Sufentanil
• Tacrolimus
• Tazemetostat
• Tramadol
• Ulipristal
• Voclosporin
• Vonoprazan
• Voxelotor
• Zolpidem
• Zuranolone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression or
• Drug abuse or dependence or
• Heart rhythm problems (eg, QT shortening) or
• Mental illness—Use with caution. May make these conditions worse.

• Heart rhythm problems (eg, familial short QT syndrome)—Should not be used in patients with this condition.

• Kidney disease, end stage or
• Liver disease, severe—Use is not recommended in patients with these conditions.

• Kidney disease, mild to severe or
• Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor, to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Swallow the tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For partial-onset seizures:
    • Adults—12.5 milligrams (mg) once a day for 2 weeks. Your doctor will gradually increase your dose every 2 weeks. However, the dose is usually not more than 400 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This is necessary to allow dose adjustments and to check for serious unwanted effects.

Serious skin reactions (including drug reaction with eosinophilia and systemic symptoms (DRESS) may occur during treatment with cenobamate. Tell your doctor right away if you have a fever, skin rashes or blisters, or swollen, painful, or tender lymph glands in neck, armpit, or groin while using this medicine.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast or uneven heartbeat that last a long time. These may be symptoms of a heart rhythm problem called QT shortening.

If you develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, suicidal thoughts, and unusual excitement, nervousness, or irritability.

Cenobamate may cause blurred vision, double vision, or other changes in vision. It may also cause some people to become dizzy, drowsy, clumsy, or feel tired. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well.

Do not stop taking cenobamate without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping the medicine suddenly may cause your seizures to return or to occur more often.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates, medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor or dentist before taking any of the above while you are taking this medicine.

Birth control pills may not work while you are using cenobamate. To keep from getting pregnant, use another form of birth control including condoms, diaphragms, or contraceptive foams or jellies.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Fast, irregular, pounding, or racing heartbeat or pulse

Incidence not known

Black, tarry stools

bloody or cloudy urine

changes in behavior

chest pain or discomfort

chills

confusion

cough

dark urine

difficulty in breathing

discouragement

drowsiness

false or unusual sense of well-being

fast heartbeat

feeling sad or empty

fever

general tiredness and weakness

headache

irritability

lack of appetite

light-colored stools

loss of interest or pleasure

muscle pain

nausea and vomiting

painful or difficult urination

rash sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling of the face, feet, or lower legs

swollen glands

swollen, painful, or tender lymph glands in the neck, armpit, or groin

thoughts of killing oneself

tiredness

trouble concentrating

trouble sleeping

unusual tiredness or weakness

unusual weight gain

upper right abdominal or stomach pain

yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blurred vision

change in walking and balance

changes in patterns and rhythms of speech

clumsiness or unsteadiness

constipation

dizziness or lightheadedness

double vision

feeling of constant movement of self or surroundings

seeing double

sensation of spinning

shakiness and unsteady walk

sleepiness or unusual drowsiness

slurred speech

trouble in speaking

uncontrolled eye movements

unsteadiness, trembling, or other problems with muscle control or coordination

Less common

Abdominal or stomach pain

acid or sour stomach

back pain

belching

change in taste

decreased appetite

diarrhea

dry mouth

heartburn

impaired memory

indigestion

itching skin

lack or loss of strength

loss of taste

muscle aches

problems with speech or speaking

sore throat

stomach discomfort or upset

stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.