Xcopri 150-200mg Titration Pak 28s
It is used to help control certain kinds of seizures.
Drug Class
Anticonvulsant
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 medicine used to treat a specific type of seizure called focal-onset seizures in adults. It works by calming overactive electrical signals in the brain that cause 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 for your dose and place them in a cup with 25 mL of water.
+ Swirl the mixture to combine.
+ Drink the mixture immediately. Do not store it for later use.
+ To ensure you take the entire dose, rinse the cup with an additional 25 mL of water and drink. If any tablet residue remains, repeat the rinse process.
Using a Feeding Tube
If you have a feeding tube, you can still use this medication. Follow the instructions provided by your healthcare provider. After administering the medication, flush the feeding tube to prevent clogging.
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
To keep your medication safe and effective:
Store it at room temperature in a dry place, away from the bathroom.
Keep it out of reach of children and pets, and store it in a secure location where others cannot access it. A locked box or area can help prevent unauthorized use.
* 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're 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 for your dose and place them in a cup with 25 mL of water.
+ Swirl the mixture to combine.
+ Drink the mixture immediately. Do not store it for later use.
+ To ensure you take the entire dose, rinse the cup with an additional 25 mL of water and drink. If any tablet residue remains, repeat the rinse process.
Using a Feeding Tube
If you have a feeding tube, you can still use this medication. Follow the instructions provided by your healthcare provider. After administering the medication, flush the feeding tube to prevent clogging.
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
To keep your medication safe and effective:
Store it at room temperature in a dry place, away from the bathroom.
Keep it out of reach of children and pets, and store it in a secure location where others cannot access it. A locked box or area can help prevent unauthorized use.
* 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're unsure, contact your doctor for guidance.
Lifestyle & Tips
- Take Xcopri exactly as prescribed, usually once a day. Do not stop taking it suddenly without talking to your doctor, as this can cause seizures to worsen.
- Follow the titration schedule carefully. Taking too much too soon can increase the risk of serious side effects.
- Avoid driving or operating machinery until you know how Xcopri affects you, as it can cause dizziness, drowsiness, and vision problems.
- Limit or avoid alcohol consumption, as it can increase 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 symptoms, especially skin rash, fever, swollen lymph nodes, or yellowing of the skin/eyes, to your doctor immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 12.5 mg once daily, titrated gradually over weeks to a target maintenance dose of 200 mg once daily. Max 400 mg once daily.
Dose Range:
12.5 - 400 mg
Condition-Specific Dosing:
titrationSchedule:
Week 1: 12.5 mg/day; Week 2: 25 mg/day; Week 3: 50 mg/day; Week 4: 100 mg/day; Week 5: 150 mg/day; Week 6: 200 mg/day. Further increases to 300 mg/day or 400 mg/day may be considered based on clinical response and tolerability, with increments of 50 mg/day every 2 weeks.
Xcopri_150_200mg_Titration_Pak:
This specific pack is designed for the later stages of titration, typically for patients who have already completed the initial titration phases and are progressing from 150 mg to 200 mg daily, or for dose adjustments within this range.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
Maximum recommended dose is 300 mg once daily.
Dialysis:
Maximum recommended dose is 300 mg once daily. Administer after dialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
Maximum recommended dose is 200 mg once daily.
Severe:
Maximum recommended dose is 150 mg once daily.
Pharmacology
Mechanism of Action
Cenobamate is an anticonvulsant that is thought to exert its therapeutic effects through a dual mechanism of action. It reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents (preferentially enhancing the inactivated state of sodium channels). It also enhances inhibitory synaptic currents by positive allosteric modulation of the GABA-A receptor, binding at a non-benzodiazepine site.
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.
Distribution:
Vd:
Not available (high volume of distribution, approximately 40-50 L)
ProteinBinding:
Approximately 60%
CnssPenetration:
Yes
Elimination:
HalfLife:
50-70 hours
Clearance:
Not available
ExcretionRoute:
Renal (approximately 93% as metabolites, <1% unchanged drug)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Not precisely defined, therapeutic effects are observed with gradual titration over weeks.
PeakEffect:
Achieved after reaching stable maintenance dose, typically several weeks into therapy.
DurationOfAction:
Due to long half-life, once-daily dosing is sufficient.
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, significant weight gain, or swelling in the arms or legs
Unexplained bruising or bleeding
Severe muscle pain or weakness
Changes in balance or coordination
Difficulty walking
Inability to control 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 behavioral changes
contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
A rare but potentially life-threatening condition has been reported 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 taking this medication do not experience significant side effects, but some may occur. If you experience 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 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, significant weight gain, or swelling in the arms or legs
Unexplained bruising or bleeding
Severe muscle pain or weakness
Changes in balance or coordination
Difficulty walking
Inability to control 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 behavioral changes
contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
A rare but potentially life-threatening condition has been reported 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 taking this medication do not experience significant side effects, but some may occur. If you experience 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 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:
- Rash (especially severe, widespread, or accompanied by other symptoms)
- Fever
- Swollen glands (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
- Muscle weakness or pain
- New or worsening drowsiness or dizziness
- Double vision
- Problems with coordination or balance
- Changes in mood or behavior, including thoughts of self-harm
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.
Certain health conditions, including:
+ 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 your health problems, as this medication may interact with other drugs or health conditions.
Remember, 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 issues 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 symptoms you experienced.
Certain health conditions, including:
+ 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 your health problems, as this medication may interact with other drugs or health conditions.
Remember, 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 issues 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, ensure 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 the frequency or severity of seizures after starting this medication, discuss these changes 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, 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, ensure 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 the frequency or severity of seizures after starting this medication, discuss these changes 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, 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
- Ataxia (loss of coordination)
- Blurred vision
- Coma
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive; there is no specific antidote.
Drug Interactions
Major Interactions
- Phenytoin (cenobamate can decrease phenytoin levels, requiring dose adjustment of phenytoin)
- Phenobarbital (cenobamate can decrease phenobarbital levels, requiring dose adjustment of phenobarbital)
- Clobazam (cenobamate can increase clobazam and N-desmethylclobazam levels, requiring dose reduction of clobazam)
- Oral contraceptives (cenobamate can decrease efficacy of hormonal contraceptives due to CYP3A4 induction)
- Drugs metabolized by CYP3A4 (e.g., midazolam, triazolam, alprazolam, simvastatin, atorvastatin, tacrolimus, cyclosporine, carbamazepine, lamotrigine, valproate - may require dose adjustments of these drugs)
- Drugs metabolized by CYP2B6 (e.g., bupropion, efavirenz - may require dose adjustments of these drugs)
- Drugs metabolized by CYP2C19 (e.g., clopidogrel, omeprazole, diazepam - may require dose adjustments of these drugs)
Moderate Interactions
Confidence Interactions
Monitoring
Baseline Monitoring
Baseline ECG
Rationale: To assess for pre-existing cardiac conduction abnormalities, although QT shortening is rare with cenobamate.
Timing: Prior to initiation
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, as cenobamate is metabolized hepatically and can cause DRESS syndrome.
Timing: Prior to initiation
Renal function tests (SCr, eGFR)
Rationale: To assess baseline renal function, as dose adjustments are needed in severe renal impairment.
Timing: Prior to initiation
Routine Monitoring
Clinical monitoring for DRESS syndrome
Frequency: Throughout treatment, especially during titration and first 3 months
Target: N/A
Action Threshold: Discontinue immediately if DRESS is suspected (fever, rash, lymphadenopathy, eosinophilia, organ involvement)
Clinical monitoring for CNS adverse reactions (somnolence, dizziness, fatigue, diplopia)
Frequency: Regularly, especially during titration
Target: N/A
Action Threshold: Consider dose reduction or slower titration if severe or intolerable
Seizure frequency and severity
Frequency: Regularly
Target: Reduction in seizure frequency
Action Threshold: Adjust dose based on efficacy and tolerability
Drug levels of co-administered AEDs (e.g., phenytoin, clobazam, phenobarbital)
Frequency: As clinically indicated, especially after cenobamate dose changes
Target: Therapeutic range for co-administered AED
Action Threshold: Adjust co-administered AED dose to maintain therapeutic levels and avoid toxicity
Symptom Monitoring
- Rash (especially severe, widespread, or accompanied by fever, lymphadenopathy, facial swelling)
- 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 weakness or pain
- New or worsening somnolence
- Dizziness
- Diplopia (double vision)
- Ataxia (loss of coordination)
- Changes in mood or behavior (e.g., depression, suicidal thoughts)
Special Patient Groups
Pregnancy
Limited human data on cenobamate use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. In animal studies, developmental toxicity (e.g., increased fetal malformations, decreased fetal weight) was observed at clinically relevant exposures. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major birth defects based on animal data and general AED class effects.
Second Trimester:
Not specifically studied, but continued exposure carries potential risks.
Third Trimester:
Not specifically studied, but continued exposure carries potential risks.
Lactation
Cenobamate is present in the milk of lactating rats. It is unknown whether cenobamate is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, including somnolence and feeding difficulties, breastfeeding is not recommended during treatment with cenobamate.
Infant Risk:
Risk L3 (Moderate concern - no human data, but animal data suggest excretion into milk and potential for adverse effects in infant).
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustments for renal or hepatic impairment may be necessary in this population.
Clinical Information
Clinical Pearls
- Strict adherence to the slow titration schedule is paramount to minimize the risk of serious adverse reactions, particularly DRESS syndrome.
- Educate patients thoroughly on the signs and symptoms of DRESS syndrome and the importance of immediate discontinuation and medical attention if suspected.
- Cenobamate is a potent enzyme inducer (CYP3A4, CYP2B6) and inhibitor (CYP2C19), requiring careful monitoring and potential dose adjustments of co-administered medications, especially other AEDs and hormonal contraceptives.
- Patients should be advised about potential CNS depressant effects (somnolence, dizziness) and cautioned against activities requiring mental alertness until they know how the drug affects them.
- Consider baseline ECG, especially in patients with pre-existing cardiac conditions, although QT shortening is rare and typically not clinically significant.
- The 150-200mg titration pack is for patients who have already tolerated lower doses and are progressing towards or maintaining the typical therapeutic range.
Alternative Therapies
- Lacosamide (Vimpat)
- Levetiracetam (Keppra)
- Lamotrigine (Lamictal)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Eslicarbazepine acetate (Aptiom)
- Perampanel (Fycompa)
- Brivaracetam (Briviact)
- Zonisamide (Zonegran)
- Topiramate (Topamax)
Cost & Coverage
Average Cost:
Varies significantly by pharmacy and insurance plan. A 28-day titration pack (e.g., 150mg-200mg) can range from $1,000 to $1,500+. per 28-day titration pack
Insurance Coverage:
Specialty Tier / Tier 4 or 5 (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 your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again each time you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.