Xcopri 150mg 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
Schedule V
Overview
What is this medicine?
Xcopri (cenobamate) is a prescription medicine used to treat partial-onset seizures (also called focal-onset seizures) in adults. It works by affecting certain chemicals and electrical signals in the brain to help reduce the number of seizures you have.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from 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 with water.
Continuing Your Medication
Continue taking your medication as directed 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 sight and 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 forget to take a dose, make sure you know what to do. If you are unsure, contact your doctor for guidance.
To ensure you get the most benefit from 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 with water.
Continuing Your Medication
Continue taking your medication as directed 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 sight and 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 forget to take 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 status epilepticus (a medical emergency with continuous seizures).
- Avoid or limit alcohol consumption while taking Xcopri, as it can increase side effects like dizziness and drowsiness.
- Be cautious when driving or operating machinery until you know how Xcopri affects you, as it can cause dizziness, drowsiness, and vision problems.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, vitamins, and herbal supplements, as Xcopri can interact with many other drugs, including birth control pills.
- Carry a medical alert card or wear a medical alert bracelet indicating you have epilepsy and are taking Xcopri.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 12.5 mg once daily for 2 weeks; Titration: Increase by 12.5 mg or 25 mg every 2 weeks to target maintenance dose; Maintenance: 200 mg once daily; Max: 400 mg once daily
Dose Range:
12.5 - 400 mg
Condition-Specific Dosing:
focal-onset seizures:
Titrate gradually to maintenance dose of 200 mg once daily. Some patients may benefit from 400 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed.
Moderate:
Initial: 12.5 mg once daily for 2 weeks; Titration: Increase by 12.5 mg or 25 mg every 2 weeks to target maintenance dose; Max: 300 mg once daily.
Severe:
Initial: 12.5 mg once daily for 2 weeks; Titration: Increase by 12.5 mg or 25 mg every 2 weeks to target maintenance dose; Max: 300 mg once daily.
Dialysis:
No specific recommendations for dialysis patients; use with caution and monitor closely. Max 300 mg once daily.
Hepatic Impairment:
Mild:
Initial: 12.5 mg once daily for 2 weeks; Titration: Increase by 12.5 mg or 25 mg every 2 weeks to target maintenance dose; Max: 200 mg once daily.
Moderate:
Initial: 12.5 mg once daily for 2 weeks; Titration: Increase by 12.5 mg or 25 mg every 2 weeks to target maintenance dose; Max: 200 mg once daily.
Severe:
Not recommended due to lack of data.
Pharmacology
Mechanism of Action
Cenobamate is an antiepileptic drug that is thought to exert its therapeutic effects through two proposed mechanisms: 1) it reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents, preferentially enhancing the inactivated state of the sodium channel; and 2) it enhances inhibitory currents through positive allosteric modulation of the GABA-A receptor, binding to a non-benzodiazepine site.
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:
50 to 70 hours (mean 60 hours)
Clearance:
Approximately 0.8 to 1.2 L/h
ExcretionRoute:
Primarily renal (approximately 93% of dose, mostly as metabolites)
Unchanged:
Less than 1% (in urine)
Pharmacodynamics
OnsetOfAction:
Not acutely defined for seizure control; steady-state concentrations are achieved after approximately 14 days of once-daily dosing.
PeakEffect:
Clinical effect is observed with titration to maintenance doses.
DurationOfAction:
Due to long half-life, once-daily dosing maintains therapeutic concentrations.
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, especially 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 can occur 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 experience any of the following side effects and they bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Headache
Constipation, diarrhea, nausea, vomiting, or decreased appetite
Nose or throat irritation
* Back pain
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, 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, especially 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 can occur 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 experience any of the following side effects and they bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Headache
Constipation, diarrhea, nausea, vomiting, or decreased appetite
Nose or throat irritation
* Back pain
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, 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:
- New or worsening rash, especially if accompanied by fever, swollen lymph nodes, or swelling of the face, eyes, lips, or tongue (signs of DRESS syndrome). Seek immediate medical attention.
- Yellowing of the skin or eyes (jaundice), dark urine, or unusual bruising/bleeding (signs of liver problems).
- New or worsening thoughts about suicide or dying, attempts to commit suicide, new or worsening depression, anxiety, or panic attacks.
- Feeling agitated, restless, aggressive, irritable, or violent.
- Acting on dangerous impulses.
- An extreme increase in activity and talking (mania).
- Other unusual changes in behavior or mood.
- Severe dizziness, extreme tiredness, or problems with coordination.
- Double vision or blurred vision.
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 medication may interact with other drugs or health conditions.
Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to consult with your doctor and pharmacist about all your medications and health problems before taking this drug. Never start, stop, or change the dose of any medication without first discussing it 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 medication may interact with other drugs or health conditions.
Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to consult with your doctor and pharmacist about all your medications and health problems before taking this drug. Never start, stop, or change the dose of any medication without first discussing it with 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 can impair your reactions.
If you experience changes in your seizures 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 guide 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. If you have a history of substance abuse or dependence on drugs or alcohol, inform your doctor.
Note that birth control pills and other hormone-based contraceptives may be less effective while taking this medication. To prevent pregnancy, use an additional form of birth control, such as condoms, in conjunction with your regular birth control method.
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 can impair your reactions.
If you experience changes in your seizures 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 guide 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. If you have a history of substance abuse or dependence on drugs or alcohol, inform your doctor.
Note that birth control pills and other hormone-based contraceptives may be less effective while taking this medication. To prevent pregnancy, use an additional form of birth control, such as condoms, in conjunction with your regular birth control method.
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 somnolence
- Dizziness
- Ataxia (loss of coordination)
- Blurred vision
- Nystagmus (involuntary eye movements)
- Coma
What to Do:
There is no specific antidote for cenobamate overdose. Treatment should be supportive and symptomatic. Contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Major Interactions
- Oral contraceptives (decreased efficacy of hormonal contraceptives)
- Phenytoin (increased phenytoin levels)
- Phenobarbital (increased phenobarbital levels)
- Clobazam (increased clobazam and N-desmethylclobazam levels)
- Lamotrigine (decreased lamotrigine levels)
- Carbamazepine (decreased carbamazepine levels)
- CYP3A4 substrates (e.g., midazolam, triazolam, alprazolam, simvastatin, atorvastatin, tacrolimus, cyclosporine, sildenafil, amlodipine, diltiazem, verapamil, quetiapine, aripiprazole, lurasidone, rivaroxaban, apixaban, dabigatran) - decreased efficacy due to induction.
- CYP2B6 substrates (e.g., bupropion, efavirenz) - decreased efficacy due to induction.
Monitoring
Baseline Monitoring
ECG (Electrocardiogram)
Rationale: To assess for QTc interval prolongation, although not a primary concern with cenobamate, it's a general precaution for new AEDs.
Timing: Prior to initiation
Baseline seizure frequency and characteristics
Rationale: To establish a baseline for assessing treatment efficacy.
Timing: Prior to initiation
Renal and hepatic function tests
Rationale: To guide initial dosing adjustments in patients with impairment.
Timing: Prior to initiation
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly, at each follow-up visit
Target: Reduction in seizure frequency, ideally seizure freedom
Action Threshold: Lack of efficacy, worsening seizures, or intolerable side effects may require dose adjustment or discontinuation.
Adverse effects (e.g., somnolence, dizziness, fatigue, diplopia)
Frequency: Regularly, especially during titration and dose changes
Target: Minimization of side effects
Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.
Signs/symptoms of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Frequency: Regularly, especially during the first 3 months of treatment
Target: Absence of rash, fever, lymphadenopathy, or organ involvement
Action Threshold: Immediate discontinuation of cenobamate if DRESS is suspected.
Mood and behavioral changes (e.g., suicidal ideation)
Frequency: Regularly, at each follow-up visit
Target: Stable mood, absence of suicidal thoughts or behaviors
Action Threshold: Prompt psychiatric evaluation and intervention if suicidal ideation or significant mood changes occur.
Symptom Monitoring
- Rash (especially severe or widespread)
- Fever
- Swollen lymph nodes
- Swelling of face, eyes, lips, or tongue
- Difficulty breathing or swallowing
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Unusual bruising or bleeding
- Severe dizziness or somnolence
- Changes in vision (e.g., double vision)
- Suicidal thoughts or behavior
- New or worsening depression or anxiety
- Panic attacks
- Agitation or restlessness
- Aggressiveness, irritability, or violence
- Insomnia
- Mania or hypomania
- Other unusual changes in behavior or mood
Special Patient Groups
Pregnancy
Cenobamate may cause fetal harm when administered to a pregnant woman. Animal studies have shown developmental toxicity (skeletal abnormalities, reduced fetal weight, increased pup mortality). There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patients should be enrolled in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
Trimester-Specific Risks:
First Trimester:
Potential for major congenital malformations based on animal data.
Second Trimester:
Potential for developmental toxicity.
Third Trimester:
Potential for developmental toxicity.
Lactation
Cenobamate is excreted into the milk of lactating rats. It is unknown whether cenobamate is excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, including somnolence, feeding difficulties, and respiratory depression, breastfeeding is not recommended during treatment with cenobamate.
Infant Risk:
High (potential for serious adverse effects)
Pediatric Use
The safety and effectiveness of cenobamate in pediatric patients have not been established. 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
- Cenobamate requires a slow titration schedule to minimize the risk of adverse events, particularly somnolence, dizziness, and the rare but serious DRESS syndrome.
- Patients should be educated about the signs and symptoms of DRESS syndrome and instructed to seek immediate medical attention if they occur.
- Cenobamate is a potent inducer of several CYP enzymes (CYP3A4, CYP2B6, CYP2C19) and a weak inducer of CYP2C9, which can significantly reduce the effectiveness of many co-administered drugs, including hormonal contraceptives. Alternative or additional birth control methods should be considered.
- Monitor for suicidal ideation and behavior, as with all antiepileptic drugs.
- Cenobamate is a Schedule V controlled substance due to its potential for abuse and dependence, though the risk is considered low.
- Consider dose adjustments for patients with moderate to severe renal impairment or mild to moderate hepatic impairment.
Alternative Therapies
- Levetiracetam (Keppra)
- Lamotrigine (Lamictal)
- Oxcarbazepine (Trileptal)
- Lacosamide (Vimpat)
- Perampanel (Fycompa)
- Brivaracetam (Briviact)
- Topiramate (Topamax)
- Zonisamide (Zonegran)
- Carbamazepine (Tegretol)
- Phenytoin (Dilantin)
Cost & Coverage
Average Cost:
$900 - $1200 per 30 tablets (150mg)
Insurance Coverage:
Tier 3 or Tier 4 (Specialty Drug)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.