Fycompa 10mg Tablets
WARNING: New or worse mental, mood, or behavior problems have happened with this drug. These problems include thoughts of suicide or murder, depression, forceful actions, fury, anxiety, and anger. These problems have happened in people with and without a history of mental or mood problems. Watch people who take this drug closely. If you think you have any of these problems, call your doctor right away. Call your doctor right away if you have any other signs like nervousness, restlessness, grouchiness, panic attacks, or any new or worse changes in mood or actions. @ COMMON USES: It is used to help control certain kinds of seizures.
Drug Class
Antiepileptic Drug (AED)
Pharmacologic Class
Selective, non-competitive AMPA receptor antagonist
Pregnancy Category
Not available
FDA Approved
Oct 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Perampanel is a medication used to treat certain types of seizures in people with epilepsy. It works by calming overactive brain signals that can cause seizures. It's taken once a day, usually at bedtime.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take this medication at bedtime as directed. Continue taking it as prescribed by your doctor or healthcare provider, even if you feel well.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding bathrooms. Keep it in a secure location where children cannot see or reach it, and other individuals cannot access it. Consider using a locked box or area to ensure safety. Keep all medications away from pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on proper disposal methods, and explore potential drug take-back programs in your area.
Missing a Dose
If you miss a dose, skip it and resume your regular schedule. Do not take two doses at the same time or extra doses. If you miss more than one day of taking this medication, consult your doctor for guidance.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take this medication at bedtime as directed. Continue taking it as prescribed by your doctor or healthcare provider, even if you feel well.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding bathrooms. Keep it in a secure location where children cannot see or reach it, and other individuals cannot access it. Consider using a locked box or area to ensure safety. Keep all medications away from pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on proper disposal methods, and explore potential drug take-back programs in your area.
Missing a Dose
If you miss a dose, skip it and resume your regular schedule. Do not take two doses at the same time or extra doses. If you miss more than one day of taking this medication, consult your doctor for guidance.
Lifestyle & Tips
- Take Fycompa exactly as prescribed, usually once daily at bedtime. Do not stop taking it suddenly, as this can increase your risk of seizures.
- Avoid alcohol while taking Fycompa, as it can increase side effects like dizziness, sleepiness, and problems with balance.
- Be aware that Fycompa can cause dizziness, sleepiness, and problems with coordination. Avoid driving or operating machinery until you know how this medication affects you.
- If you are a woman of childbearing potential, discuss effective contraception methods with your doctor, as Fycompa can reduce the effectiveness of some hormonal birth control pills (especially those containing levonorgestrel).
- Report any new or worsening mood changes, aggression, hostility, irritability, or thoughts of self-harm to your doctor immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 2 mg once daily at bedtime; titrate by 2 mg/day increments weekly. Maintenance 4-12 mg once daily.
Dose Range:
2 - 12 mg
Condition-Specific Dosing:
Partial-onset seizures (POS) with or without secondary generalization:
Initial 2 mg once daily, titrate to 4-12 mg once daily.
Primary generalized tonic-clonic seizures (PGTCS):
Initial 2 mg once daily, titrate to 8-12 mg once daily.
Concomitant strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, oxcarbazepine):
Maximum dose 8 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
POS (âĨ4 years): Initial 2 mg once daily, titrate by 2 mg/day increments weekly. Maintenance 4-12 mg once daily (weight-based considerations for younger children). PGTCS (âĨ7 years): Initial 2 mg once daily, titrate by 2 mg/day increments weekly. Maintenance 8-12 mg once daily (weight-based considerations for younger children).
Adolescent:
Dosing similar to adults, based on seizure type and tolerability.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
Not studied; use with caution.
Dialysis:
Not studied; use with caution.
Hepatic Impairment:
Mild:
Maximum dose 8 mg once daily (Child-Pugh A).
Moderate:
Maximum dose 8 mg once daily (Child-Pugh B).
Severe:
Not recommended (Child-Pugh C).
Pharmacology
Mechanism of Action
Perampanel is a selective, non-competitive antagonist of the ionotropic Îą-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on postsynaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system, and AMPA receptors mediate fast synaptic transmission. By blocking AMPA receptors, perampanel reduces neuronal hyperexcitability, thereby decreasing seizure activity.
Pharmacokinetics
Absorption:
Bioavailability:
High (nearly complete)
Tmax:
0.5-2.5 hours
FoodEffect:
Food can delay Tmax by 2-3 hours but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
107 L
ProteinBinding:
95-96%
CnssPenetration:
Yes
Elimination:
HalfLife:
70-105 hours (can be shorter, e.g., 25-46 hours, with concomitant enzyme-inducing AEDs)
Clearance:
Not available
ExcretionRoute:
Approximately 70% via urine (as metabolites), 30% via feces (as metabolites)
Unchanged:
<1% (urine)
Pharmacodynamics
OnsetOfAction:
Gradual (due to titration schedule)
PeakEffect:
Steady-state concentrations achieved within 2-3 weeks with once-daily dosing.
DurationOfAction:
Long (due to long half-life, supports once-daily dosing)
Safety & Warnings
BLACK BOX WARNING
Serious psychiatric and behavioral adverse reactions, including aggression, hostility, irritability, anger, and homicidal ideation and threats, have been reported in patients taking FYCOMPA. These reactions occurred in patients with and without a history of psychiatric problems, and some patients had no prior history of aggression, hostility, or anger. Monitor patients for these reactions and consider dose reduction or discontinuation if they occur.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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
Confusion
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Changes in balance
Severe dizziness or fainting
Difficulty walking
Shortness of breath, significant weight gain, or swelling in the arms or legs
A rare but serious 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 pass urine
+ Changes in the amount of urine passed
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Upset stomach or vomiting
Back pain
Weight gain
Stomach pain
* Bruising
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 right away:
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
Confusion
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Changes in balance
Severe dizziness or fainting
Difficulty walking
Shortness of breath, significant weight gain, or swelling in the arms or legs
A rare but serious 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 pass urine
+ Changes in the amount of urine passed
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Upset stomach or vomiting
Back pain
Weight gain
Stomach pain
* Bruising
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:
- Unusual changes in mood or behavior (e.g., increased aggression, anger, hostility, irritability)
- Thoughts of harming yourself or others (including homicidal ideation)
- New or worsening depression or anxiety
- Panic attacks
- Restlessness or agitation
- Insomnia
- Psychotic symptoms (e.g., hallucinations, delusions)
- Severe dizziness or loss of balance
- Extreme sleepiness
- Unexplained weight gain
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.
If you have a history of kidney disease or liver disease, as these conditions may affect how your body processes this medication.
This list is not exhaustive, and it is crucial to discuss all your health concerns with your doctor. Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Any existing health problems you have
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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.
If you have a history of kidney disease or liver disease, as these conditions may affect how your body processes this medication.
This list is not exhaustive, and it is crucial to discuss all your health concerns with your doctor. Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Any existing health problems you have
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 your full attention, wait until you understand how this medication affects you. It is also crucial to discuss the use of alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness, with your doctor beforehand.
Do not abruptly stop taking this medication without first consulting your doctor, as this may increase your risk of experiencing seizures. If you need to discontinue this medication, your doctor will provide guidance on how to gradually taper off the dosage.
This medication may increase your risk of falling, which can lead to severe complications such as head injuries and fractures. Older adults are at a higher risk of falls. It is vital to discuss this with your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
When using birth control pills or other hormone-based birth control products containing levonorgestrel, this medication may reduce their effectiveness in preventing pregnancy. To minimize the risk of unplanned pregnancy, consider using an additional form of birth control, such as a condom, while taking this medication and for one month after your last dose. If you have any questions or concerns, consult your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. It is also crucial to discuss the use of alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness, with your doctor beforehand.
Do not abruptly stop taking this medication without first consulting your doctor, as this may increase your risk of experiencing seizures. If you need to discontinue this medication, your doctor will provide guidance on how to gradually taper off the dosage.
This medication may increase your risk of falling, which can lead to severe complications such as head injuries and fractures. Older adults are at a higher risk of falls. It is vital to discuss this with your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
When using birth control pills or other hormone-based birth control products containing levonorgestrel, this medication may reduce their effectiveness in preventing pregnancy. To minimize the risk of unplanned pregnancy, consider using an additional form of birth control, such as a condom, while taking this medication and for one month after your last dose. If you have any questions or concerns, consult your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Dizziness
- Irritability
- Aggression
- Nausea
- Vomiting
- Somnolence
- Fatigue
- Ataxia
- Disorientation
- Coma
What to Do:
There is no specific antidote for perampanel overdose. Treatment is supportive and symptomatic. Consider activated charcoal if ingestion is recent. Contact a poison control center immediately (e.g., call 1-800-222-1222 in the US).
Drug Interactions
Major Interactions
- Strong CYP3A4/5 inducers (e.g., carbamazepine, phenytoin, oxcarbazepine, rifampin): May significantly decrease perampanel plasma concentrations, requiring higher perampanel doses (up to 12 mg/day, but max 8 mg/day if on these inducers).
- Levonorgestrel-containing oral contraceptives: Perampanel (at doses >8 mg/day) can decrease the efficacy of levonorgestrel. Advise use of non-hormonal contraception or alternative hormonal methods.
Moderate Interactions
- Alcohol: Increased risk of CNS depression (dizziness, somnolence, gait disturbance, irritability).
- Other CNS depressants (e.g., benzodiazepines, opioids, sedating antihistamines): Additive CNS depressant effects.
- Valproate: May slightly increase perampanel levels (usually not clinically significant).
Minor Interactions
- Grapefruit juice: Potential for minor increase in perampanel levels due to CYP3A4 inhibition.
Monitoring
Baseline Monitoring
Psychiatric history
Rationale: To assess baseline risk for psychiatric/behavioral adverse reactions, including aggression, hostility, and suicidal ideation.
Timing: Prior to initiation of therapy.
Seizure frequency and characteristics
Rationale: To establish baseline for efficacy assessment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Psychiatric and behavioral changes (e.g., aggression, hostility, irritability, suicidal ideation)
Frequency: Regularly, especially during titration and dose adjustments.
Target: Absence of new or worsening symptoms.
Action Threshold: Any new or worsening symptoms warrant immediate evaluation and consideration of dose reduction or discontinuation.
Neurological adverse effects (e.g., dizziness, somnolence, gait disturbance)
Frequency: Regularly, especially during titration.
Target: Tolerable levels.
Action Threshold: Significant or intolerable symptoms may require dose reduction or slower titration.
Seizure control
Frequency: Regularly.
Target: Reduction in seizure frequency/severity.
Action Threshold: Lack of efficacy may warrant dose increase (up to max tolerated dose) or consideration of alternative therapy.
Symptom Monitoring
- Aggression
- Hostility
- Irritability
- Anger
- Homicidal ideation/threats
- Suicidal ideation/behavior
- Depression
- Anxiety
- Psychosis
- Dizziness
- Somnolence
- Fatigue
- Ataxia
- Gait disturbance
- Nausea
- Weight gain
Special Patient Groups
Pregnancy
Perampanel may cause fetal harm. Data from animal studies show developmental toxicity (e.g., skeletal abnormalities, reduced fetal weight). Human data are limited but suggest potential risks. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Enrollment in a pregnancy registry (e.g., North American Antiepileptic Drug Pregnancy Registry) is recommended.
Trimester-Specific Risks:
First Trimester:
Potential for major congenital malformations; data are limited.
Second Trimester:
Potential for adverse developmental outcomes; data are limited.
Third Trimester:
Potential for adverse developmental outcomes; data are limited.
Lactation
Perampanel is excreted into human milk. The effects on the breastfed infant are unknown. Monitor breastfed infants for sedation, poor feeding, and developmental milestones. 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:
L3 (Moderate risk - monitor infant for adverse effects)
Pediatric Use
Approved for partial-onset seizures in patients 4 years and older, and for primary generalized tonic-clonic seizures in patients 7 years and older. Dosing is weight-based for younger children, with careful titration. Safety and efficacy in children younger than 4 years (POS) or 7 years (PGTCS) have not been established.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the adverse effects (e.g., dizziness, somnolence, gait disturbance) and should be monitored closely.
Clinical Information
Clinical Pearls
- Perampanel has a long half-life, allowing for once-daily dosing, typically at bedtime to mitigate CNS side effects.
- Slow titration is crucial to minimize dose-related adverse effects such as dizziness, somnolence, and psychiatric/behavioral changes.
- The Black Box Warning for serious psychiatric and behavioral reactions (including aggression and homicidal ideation) is a significant concern; patients and caregivers must be educated to monitor for these symptoms.
- Perampanel can reduce the effectiveness of levonorgestrel-containing oral contraceptives; advise alternative or additional non-hormonal contraception.
- Concomitant use with strong CYP3A4/5 inducers (e.g., carbamazepine, phenytoin, oxcarbazepine) can significantly reduce perampanel levels, often requiring higher perampanel doses (up to 8 mg/day maximum when on these inducers).
- Avoid alcohol due to additive CNS depressant effects.
Alternative Therapies
- Levetiracetam
- Lamotrigine
- Topiramate
- Valproate
- Carbamazepine
- Oxcarbazepine
- Lacosamide
- Zonisamide
- Brivaracetam
- Cenobamate
Cost & Coverage
Average Cost:
Price varies widely, typically high for brand-name. per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 about its use. 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, don't hesitate 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 reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. 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, don't hesitate 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 reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.