Xcopri 200mg Tablets
It is used to help control certain kinds of seizures.
Drug Class
Antiepileptic drug (AED)
Pharmacologic Class
Sodium channel blocker; GABA-A receptor positive allosteric modulator
Pregnancy Category
Not available
FDA Approved
Nov 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Xcopri (cenobamate) is a prescription medicine used to treat partial-onset seizures (also known as focal-onset seizures) in adults. It works by affecting certain electrical signals in the brain to help reduce the frequency of seizures.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
If you have difficulty swallowing the tablets whole, you can mix them with water. To do this, crush the required number of tablets and add them to 25 mL of water in a cup. Stir the mixture well and drink it immediately. Do not store the mixture for later use.
To make sure you take the entire dose, rinse the cup with an additional 25 mL of water and drink it. If any tablet residue remains in the cup, repeat the rinsing process.
If you have a feeding tube, you can use this medication as directed by your healthcare provider. After administering the medication, flush the feeding tube.
Continuing Your Medication
Continue taking your medication as instructed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Keep your medication in a safe and secure location, out of reach of children and pets. Consider using a locked box or area to store your medication.
* Keep all medications away from pets.
Missing a Dose
If you miss a dose, make sure you know what to do. If you are unsure, contact your doctor for guidance.
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
If you have difficulty swallowing the tablets whole, you can mix them with water. To do this, crush the required number of tablets and add them to 25 mL of water in a cup. Stir the mixture well and drink it immediately. Do not store the mixture for later use.
To make sure you take the entire dose, rinse the cup with an additional 25 mL of water and drink it. If any tablet residue remains in the cup, repeat the rinsing process.
If you have a feeding tube, you can use this medication as directed by your healthcare provider. After administering the medication, flush the feeding tube.
Continuing Your Medication
Continue taking your medication as instructed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Keep your medication in a safe and secure location, out of reach of children and pets. Consider using a locked box or area to store your medication.
* Keep all medications away from pets.
Missing a Dose
If you miss a dose, make sure you know what to do. If you are unsure, contact your doctor for guidance.
Lifestyle & Tips
- Take Xcopri exactly as prescribed by your doctor. Do not stop taking it suddenly, as this can cause serious problems, including seizures.
- Avoid driving or operating machinery until you know how Xcopri affects you, as it can cause dizziness, somnolence, and vision problems.
- Avoid alcohol and other CNS depressants while taking Xcopri, as they can increase side effects like dizziness and drowsiness.
- Use effective non-hormonal birth control if you are a woman of childbearing potential, as Xcopri can make hormonal birth control less effective.
- Report any new or worsening mood changes, depression, or suicidal thoughts to your doctor immediately.
- Report any rash, fever, swollen lymph nodes, or signs of organ problems (e.g., yellowing skin/eyes, dark urine) immediately, as these could be signs of a serious allergic reaction (DRESS syndrome).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 12.5 mg once daily for 2 weeks. Titrate gradually to maintenance dose. Maintenance dose: 200 mg once daily. Max dose: 400 mg once daily.
Dose Range:
12.5 - 400 mg
Condition-Specific Dosing:
titrationSchedule:
Week 1-2: 12.5 mg/day; Week 3-4: 25 mg/day; Week 5-6: 50 mg/day; Week 7-8: 100 mg/day; Week 9-10: 150 mg/day; Week 11 onwards: 200 mg/day (or further titration up to 400 mg/day based on response and tolerability).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
Maximum recommended dose is 300 mg/day.
Severe:
Maximum recommended dose is 300 mg/day.
Dialysis:
Consider dose reduction; cenobamate is not dialyzable. Maximum recommended dose is 300 mg/day.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
Maximum recommended dose is 200 mg/day.
Severe:
Maximum recommended dose is 200 mg/day.
Pharmacology
Mechanism of Action
Cenobamate is an antiepileptic drug that reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents. It also acts as a positive allosteric modulator of the GABA-A ion channel, enhancing inhibitory synaptic currents.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80%
Tmax:
1 to 4 hours
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
Approximately 40-50 L
ProteinBinding:
Approximately 60%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 50-60 hours
Clearance:
Not available
ExcretionRoute:
Primarily renal (approximately 80-90%), with a smaller portion eliminated via feces (approximately 10-20%).
Unchanged:
Less than 1% (renal)
Pharmacodynamics
OnsetOfAction:
Not acutely defined for seizure control; therapeutic effects are achieved with gradual titration to steady-state concentrations.
PeakEffect:
Steady-state concentrations are typically reached within 14 days with daily dosing.
DurationOfAction:
Due to its long half-life, once-daily dosing provides sustained therapeutic levels.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Abnormal or rapid heartbeat
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Unexplained bruising or bleeding
Severe muscle pain or weakness
Balance problems
Difficulty walking
Uncontrolled eye movements
Memory problems or loss
Confusion, difficulty focusing, or changes in behavior
Speech difficulties
Changes in vision
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. If you experience any new or worsening symptoms, such as:
Depression
Anxiety, restlessness, or irritability
Panic attacks
Mood or behavior changes
contact your doctor right away. If you have suicidal thoughts or actions, seek help immediately.
A rare but potentially life-threatening condition has occurred in people taking seizure medications like this one. If you experience any of the following symptoms, contact your doctor right away:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness, drowsiness, fatigue, or weakness
Headache
Constipation, diarrhea, nausea, vomiting, or decreased appetite
Nose or throat irritation
* Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Abnormal or rapid heartbeat
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Unexplained bruising or bleeding
Severe muscle pain or weakness
Balance problems
Difficulty walking
Uncontrolled eye movements
Memory problems or loss
Confusion, difficulty focusing, or changes in behavior
Speech difficulties
Changes in vision
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. If you experience any new or worsening symptoms, such as:
Depression
Anxiety, restlessness, or irritability
Panic attacks
Mood or behavior changes
contact your doctor right away. If you have suicidal thoughts or actions, seek help immediately.
A rare but potentially life-threatening condition has occurred in people taking seizure medications like this one. If you experience any of the following symptoms, contact your doctor right away:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness, drowsiness, fatigue, or weakness
Headache
Constipation, diarrhea, nausea, vomiting, or decreased appetite
Nose or throat irritation
* Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe rash (especially with fever, swollen glands, or organ involvement)
- Suicidal thoughts or behavior
- New or worsening depression or anxiety
- Unusual changes in mood or behavior
- Severe dizziness or drowsiness
- Double vision or blurred vision
- Problems with coordination or balance
- Difficulty speaking
- Swelling of the face, lips, or tongue
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Existing health conditions, specifically:
+ Kidney disease
+ Liver disease
+ Familial Short QT syndrome
All medications you are currently taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
All health problems you have, as this is not an exhaustive list of potential interactions with this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Existing health conditions, specifically:
+ Kidney disease
+ Liver disease
+ Familial Short QT syndrome
All medications you are currently taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
All health problems you have, as this is not an exhaustive list of potential interactions with this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in any activity that requires alertness and clear vision, wait until you understand how this medication affects you.
Consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
If you experience changes in your seizure patterns or if they worsen after starting this medication, discuss this with your doctor promptly.
Do not abruptly discontinue this medication without first consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dosage.
Be aware that this medication has the potential for abuse and dependence. Adhere strictly to your doctor's instructions for taking this medication, and inform your doctor if you have a history of substance abuse or dependence on drugs or alcohol.
If you are using birth control pills or other hormone-based contraceptives, note that this medication may reduce their effectiveness. As a precaution, use an additional form of birth control, such as condoms, while taking this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Before operating a vehicle or engaging in any activity that requires alertness and clear vision, wait until you understand how this medication affects you.
Consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
If you experience changes in your seizure patterns or if they worsen after starting this medication, discuss this with your doctor promptly.
Do not abruptly discontinue this medication without first consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dosage.
Be aware that this medication has the potential for abuse and dependence. Adhere strictly to your doctor's instructions for taking this medication, and inform your doctor if you have a history of substance abuse or dependence on drugs or alcohol.
If you are using birth control pills or other hormone-based contraceptives, note that this medication may reduce their effectiveness. As a precaution, use an additional form of birth control, such as condoms, while taking this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Dizziness
- Confusion
- Difficulty breathing
- Coma
What to Do:
Seek immediate medical attention or call 911. Contact a poison control center at 1-800-222-1222. Management is supportive and symptomatic. There is no specific antidote.
Drug Interactions
Major Interactions
- Oral contraceptives (decreased efficacy due to CYP3A4 induction)
- Phenytoin (increased phenytoin levels due to CYP2C19 inhibition; decreased cenobamate levels due to CYP2C19 induction)
- Phenobarbital (decreased phenobarbital levels due to CYP2B6 induction)
- Clobazam (increased N-desmethylclobazam levels due to CYP2C19 inhibition)
- Other CNS depressants (additive CNS depression)
Moderate Interactions
- Midazolam (decreased midazolam levels due to CYP3A4 induction)
- Lamotrigine (potential for decreased lamotrigine levels)
- Valproate (potential for decreased valproate levels)
- Drugs that shorten QTc interval (theoretical additive effect, though cenobamate itself can shorten QTc)
Monitoring
Baseline Monitoring
ECG
Rationale: To assess baseline QTc interval, as cenobamate can cause QTc shortening.
Timing: Prior to initiation
Liver function tests (LFTs)
Rationale: Although not routinely required, consider in patients with pre-existing hepatic impairment or risk factors.
Timing: Prior to initiation (if indicated)
Renal function tests
Rationale: To assess baseline renal function for dose adjustment.
Timing: Prior to initiation
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly throughout treatment
Target: Reduction in seizure activity
Action Threshold: Lack of efficacy or worsening seizures may require dose adjustment or alternative therapy.
Adverse effects (e.g., dizziness, somnolence, fatigue, diplopia)
Frequency: Regularly, especially during titration
Target: Tolerable levels
Action Threshold: Intolerable side effects may require dose reduction or slower titration.
Signs/symptoms of DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
Frequency: Regularly, especially during the first 3 months
Target: Absence of symptoms
Action Threshold: Rash with fever, lymphadenopathy, or organ involvement (e.g., hepatitis, nephritis, myocarditis) requires immediate discontinuation and medical evaluation.
Mood and behavior changes (e.g., suicidal ideation)
Frequency: Regularly
Target: Stable mood
Action Threshold: New or worsening depression, suicidal thoughts, or unusual behavior changes require immediate evaluation.
Symptom Monitoring
- Rash (especially if accompanied by fever, swollen lymph nodes, or organ involvement)
- Dizziness
- Somnolence
- Fatigue
- Diplopia (double vision)
- Headache
- Nausea
- Vomiting
- Constipation
- Dry mouth
- Changes in mood or behavior (e.g., depression, anxiety, agitation, suicidal thoughts)
- Coordination problems (ataxia, gait disturbance)
- Speech problems (dysarthria)
- Cognitive impairment (e.g., memory problems, confusion)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of cenobamate in pregnant women. Based on animal studies, cenobamate may cause fetal harm. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy registry is available.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations based on animal data.
Second Trimester:
Potential for developmental toxicity based on animal data.
Third Trimester:
Potential for developmental toxicity based on animal data.
Lactation
Cenobamate is excreted into breast milk in animals. It is unknown if cenobamate is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for somnolence, feeding difficulties, and other adverse effects in breastfed infants.
Pediatric Use
The safety and effectiveness of Xcopri in pediatric patients have not been established. It is not approved for use in patients younger than 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. However, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Slow titration is critical to minimize the risk of serious adverse reactions, particularly DRESS syndrome and CNS-related effects.
- Patients should be educated on the signs and symptoms of DRESS syndrome and instructed to seek immediate medical attention if they occur.
- Cenobamate can shorten the QTc interval; caution is advised when co-administering with other drugs that shorten QTc.
- Due to its enzyme induction properties, cenobamate can significantly reduce the effectiveness of hormonal contraceptives. Advise patients to use alternative or additional non-hormonal birth control methods.
- Monitor for changes in mood or behavior, including suicidal ideation, as with all antiepileptic drugs.
Alternative Therapies
- Levetiracetam
- Lamotrigine
- Lacosamide
- Carbamazepine
- Oxcarbazepine
- Topiramate
- Zonisamide
- Perampanel
- Brivaracetam
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to over a thousand USD per 30 tablets
Insurance Coverage:
Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.