Xcopri 50-100mg Titration Pak 28s
It is used to help control certain kinds of seizures.
Drug Class
Antiepileptic drug (AED)
Pharmacologic Class
Voltage-gated sodium channel inhibitor; 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 medication used to treat partial-onset seizures (also called focal-onset seizures) in adults. It works by calming overactive nerve signals in the brain that cause seizures. It's important to start this medication at a very low dose and slowly increase it over several weeks to reduce the risk of a serious skin reaction.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this 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 for your dose and add them to a cup containing 25 mL of water. Swirl the mixture until it is well combined, then 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 still use this medication. Follow the instructions provided by your healthcare provider and flush the feeding tube after administering the medication.
Continue taking this 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, avoiding bathrooms. Keep it in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or secure area to store your medication. Keep all medications out of reach of 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 out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this 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 for your dose and add them to a cup containing 25 mL of water. Swirl the mixture until it is well combined, then 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 still use this medication. Follow the instructions provided by your healthcare provider and flush the feeding tube after administering the medication.
Continue taking this 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, avoiding bathrooms. Keep it in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or secure area to store your medication. Keep all medications out of reach of 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, usually once daily. Do not stop taking it suddenly without consulting your doctor, as this can worsen seizures.
- Avoid driving or operating heavy machinery until you know how Xcopri affects you, as it can cause dizziness, drowsiness, and vision problems.
- Avoid or limit alcohol consumption, as it can increase the risk of side effects like dizziness and drowsiness.
- Use effective non-hormonal birth control methods if you are taking hormonal contraceptives, as Xcopri can make them less effective.
- Report any new or worsening mood changes, depression, or suicidal thoughts to your doctor immediately.
- Carry a medical alert card or wear medical alert jewelry 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. Titrate every 2 weeks: 25 mg, 50 mg, 100 mg, 150 mg, 200 mg once daily. Maintenance: 200-400 mg once daily. (The 50-100mg Titration Pak is part of this titration schedule).
Dose Range:
12.5 - 400 mg
Condition-Specific Dosing:
focalonset_seizures:
Initial: 12.5 mg once daily for 2 weeks. Titrate every 2 weeks: 25 mg, 50 mg, 100 mg, 150 mg, 200 mg once daily. Maintenance: 200-400 mg once daily. Max 400 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and effectiveness not established in pediatric patients <18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
Consider starting at 12.5 mg once daily and titrating to a maximum of 300 mg once daily.
Severe:
Consider starting at 12.5 mg once daily and titrating to a maximum of 300 mg once daily.
Dialysis:
Consider starting at 12.5 mg once daily and titrating to a maximum of 300 mg once daily. Administer after dialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
Consider starting at 12.5 mg once daily and titrating to a maximum of 200 mg once daily.
Severe:
Consider starting at 12.5 mg once daily and titrating to a maximum of 200 mg once daily.
Pharmacology
Mechanism of Action
Cenobamate is an antiepileptic drug that is thought to reduce 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:
1-4 hours
FoodEffect:
Food does not affect the extent of absorption, but may delay Tmax by 1-2 hours. Can be taken with or without food.
Distribution:
Vd:
40-50 L
ProteinBinding:
Approximately 60%
CnssPenetration:
Yes
Elimination:
HalfLife:
50-70 hours
Clearance:
Approximately 10 L/hour (oral clearance)
ExcretionRoute:
Mainly renal (87% as metabolites), minor fecal (13%)
Unchanged:
<1% in urine
Pharmacodynamics
OnsetOfAction:
Within days to weeks (due to slow titration)
PeakEffect:
Achieved after reaching stable maintenance dose (weeks to months)
DurationOfAction:
Prolonged due to long half-life, allowing once-daily dosing
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 immediate medical attention:
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 immediately. If you have suicidal thoughts or actions, seek help right away.
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 immediately:
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 an exhaustive list of 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 immediate medical attention:
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 immediately. If you have suicidal thoughts or actions, seek help right away.
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 immediately:
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 an exhaustive list of 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 skin rash (especially if severe, widespread, blistering, or accompanied by fever)
- Fever
- Swollen lymph nodes
- Swelling of the face, eyes, lips, or tongue
- Difficulty breathing or swallowing
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Unusual bruising or bleeding
- Severe fatigue or weakness
- New or worsening depression, anxiety, or suicidal thoughts
- Unusual changes in behavior or mood
- Severe dizziness or drowsiness
- 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 symptoms you experienced.
If you have kidney disease or liver disease, as these conditions may affect how your body processes the medication.
If you have been diagnosed with Familial Short QT syndrome, a heart condition that may be exacerbated by certain medications.
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Any health problems you have, as they may interact with this medication
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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 symptoms you experienced.
If you have kidney disease or liver disease, as these conditions may affect how your body processes the medication.
If you have been diagnosed with Familial Short QT syndrome, a heart condition that may be exacerbated by certain medications.
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Any health problems you have, as they may interact with this medication
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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 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 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. Consider using an additional form of birth control, such as condoms, to prevent pregnancy.
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 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 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. Consider using an additional form of birth control, such as condoms, to prevent pregnancy.
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
- Ataxia (loss of coordination)
- Coma
What to Do:
Seek immediate medical attention or call 911. Contact a poison control center at 1-800-222-1222. Treatment is generally supportive, including close monitoring of vital signs and clinical status.
Drug Interactions
Major Interactions
- Phenytoin (Cenobamate can decrease phenytoin levels)
- Phenobarbital (Cenobamate can decrease phenobarbital levels)
- Clobazam (Cenobamate can increase clobazam and N-desmethylclobazam levels)
- Oral Contraceptives (Cenobamate can decrease efficacy of hormonal contraceptives)
- Drugs that shorten QTc interval (additive effect, monitor ECG)
Moderate Interactions
- CYP3A4 substrates (e.g., midazolam, alprazolam, simvastatin, tacrolimus, cyclosporine - Cenobamate can decrease their levels)
- CYP2B6 substrates (e.g., bupropion, efavirenz - Cenobamate can decrease their levels)
- CYP2C19 substrates (e.g., omeprazole, diazepam - Cenobamate can increase their levels)
Confidence Interactions
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess QTc interval, as cenobamate can cause dose-dependent QTc shortening.
Timing: Prior to initiation, especially if patient has cardiac disease or is on other QTc-shortening drugs.
Liver function tests (LFTs)
Rationale: Although rare, DRESS syndrome can involve hepatic injury. Baseline assessment is prudent.
Timing: Prior to initiation.
Renal function tests (e.g., SCr, eGFR)
Rationale: To guide dose adjustments in patients with renal impairment.
Timing: Prior to initiation.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly throughout treatment
Target: Reduction in seizure frequency
Action Threshold: Lack of efficacy or worsening seizures may require dose adjustment or alternative therapy.
Adverse effects (e.g., somnolence, dizziness, fatigue, diplopia, headache, nausea)
Frequency: At each visit, especially during titration
Target: Tolerable levels
Action Threshold: Intolerable side effects may require dose reduction or slower titration.
Signs/symptoms of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Frequency: Regularly, especially during the first 3 months of treatment
Target: Absence of symptoms
Action Threshold: Rash, fever, lymphadenopathy, eosinophilia, or organ involvement (e.g., hepatitis, nephritis, myocarditis) requires immediate discontinuation and medical evaluation.
Mood and behavior changes (e.g., suicidal ideation, depression)
Frequency: Regularly
Target: Stable mood
Action Threshold: New or worsening depression, suicidal thoughts, or unusual changes in mood/behavior require immediate evaluation.
Symptom Monitoring
- Rash (especially severe, widespread, or blistering)
- 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 fatigue
- Muscle pain or weakness
- New or worsening depression
- Suicidal thoughts or behavior
- Anxiety, agitation, panic attacks
- Insomnia
- Irritability
- Hostility or aggression
- Impulsivity
- Restlessness
- Mania or hypomania
Special Patient Groups
Pregnancy
Cenobamate may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. Based on animal studies, cenobamate may cause developmental toxicity. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Advise pregnant patients to enroll 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 based on animal data.
Third Trimester:
Potential for developmental toxicity based on animal data.
Lactation
It is unknown if cenobamate is excreted in human milk. Cenobamate was excreted in the milk of lactating rats. Because of the potential for serious adverse reactions in breastfed infants, including sedation and feeding difficulties, advise women not to breastfeed during treatment with cenobamate and for 3 days after the last dose.
Infant Risk:
L3 (Moderate risk - potential for sedation, feeding difficulties, and other adverse effects based on drug properties and animal data. Advise against breastfeeding.)
Pediatric Use
Safety and effectiveness in pediatric patients under 18 years of age have not been established. Use is not recommended.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients and younger adults, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment based on age alone is not necessary, but consider age-related decreases in renal and hepatic function.
Clinical Information
Clinical Pearls
- Strict adherence to the slow titration schedule is crucial to minimize the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a severe and potentially fatal hypersensitivity reaction.
- Patients should be educated on the signs and symptoms of DRESS and instructed to seek immediate medical attention if they occur.
- Cenobamate can cause dose-dependent QTc shortening. ECG monitoring may be considered, especially in patients with pre-existing cardiac conditions or those taking other QTc-shortening drugs.
- Cenobamate is a strong inducer of CYP3A4 and CYP2B6, and a moderate inhibitor of CYP2C19. This can lead to significant drug-drug interactions, particularly with oral contraceptives, phenytoin, phenobarbital, and clobazam.
- Due to its long half-life, once-daily dosing is possible, which may improve adherence.
- CNS adverse effects (somnolence, dizziness, fatigue, diplopia) are common, especially during titration. Patients should be advised to avoid activities requiring mental alertness until they know how the drug affects them.
Alternative Therapies
- Lacosamide
- Levetiracetam
- Lamotrigine
- Carbamazepine
- Oxcarbazepine
- Topiramate
- Zonisamide
- Perampanel
- Brivaracetam
Cost & Coverage
Average Cost:
Varies, typically $1000-$1500+ per 30 tablets (for maintenance doses)
Insurance Coverage:
Tier 3 or 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 and effective treatment, 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. It is vital 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 guidance.
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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is vital 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 guidance.
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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.