Fycompa 12mg 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
Schedule III
Overview
What is this medicine?
Perampanel is a medication used to help control seizures in people with epilepsy. It works by calming down 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 medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Consult your pharmacist for guidance on proper disposal methods, and inquire about 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 medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Consult your pharmacist for guidance on proper disposal methods, and inquire about 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
- Avoid alcohol while taking this medication, as it can increase side effects like dizziness, sleepiness, and mood changes.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- Report any new or worsening mood changes, aggression, hostility, or thoughts of self-harm to your doctor immediately.
- Do not stop taking this medication suddenly without talking to your doctor, as this can cause seizures to worsen.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 2 mg once daily at bedtime. Titrate by 2 mg increments weekly. Maintenance: 4-12 mg once daily.
Dose Range:
2 - 12 mg
Condition-Specific Dosing:
Focal-onset seizures (with or without secondary generalization):
Initial: 2 mg once daily. Titrate by 2 mg increments weekly to a maintenance dose of 4-12 mg once daily.
Primary generalized tonic-clonic seizures:
Initial: 2 mg once daily. Titrate by 2 mg increments weekly to a maintenance dose of 8-12 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Focal-onset seizures (âĨ4 years): Initial 2 mg once daily. Titrate by 2 mg increments weekly to 4-12 mg once daily. Primary generalized tonic-clonic seizures (âĨ7 years): Initial 2 mg once daily. Titrate by 2 mg increments weekly to 8-12 mg once daily.
Adolescent:
Focal-onset seizures (âĨ4 years): Initial 2 mg once daily. Titrate by 2 mg increments weekly to 4-12 mg once daily. Primary generalized tonic-clonic seizures (âĨ7 years): Initial 2 mg once daily. Titrate by 2 mg increments weekly to 8-12 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
Not recommended due to lack of data.
Dialysis:
Not recommended due to lack of data.
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
Maximum dose 6 mg/day. Use with caution.
Severe:
Not recommended due to lack of data.
Confidence:
High
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 is thought to reduce neuronal hyperexcitability, thereby reducing seizure activity.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (well-absorbed)
Tmax:
0.5-2.5 hours
FoodEffect:
Food does not affect the extent of absorption, but may delay Tmax by 2-3 hours.
Distribution:
Vd:
102 L
ProteinBinding:
95-96%
CnssPenetration:
Yes
Elimination:
HalfLife:
70 hours (range 48-106 hours)
Clearance:
Not available
ExcretionRoute:
Mainly urine (70%, mostly as metabolites), feces (30%, mostly as metabolites).
Unchanged:
Less than 4% (urine), less than 2% (feces)
Pharmacodynamics
OnsetOfAction:
Within hours (based on Tmax), clinical effect seen with titration.
PeakEffect:
Achieved after several weeks of titration to maintenance dose.
DurationOfAction:
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 have occurred in patients with and without a history of psychiatric problems, and some patients have required hospitalization. Suicidal ideation and behavior have also been reported. Patients should be monitored for these reactions, and the dose should be reduced or the drug discontinued if they occur.
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
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
In rare cases, people taking seizure medications like this one may experience a severe and potentially deadly reaction. Seek medical help immediately if you experience:
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
+ 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, or if they bother you or persist, contact your doctor or seek medical help:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Upset stomach or vomiting
Back pain
Weight gain
Stomach pain
* Bruising
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek 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
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
In rare cases, people taking seizure medications like this one may experience a severe and potentially deadly reaction. Seek medical help immediately if you experience:
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
+ 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, or if they bother you or persist, contact your doctor or seek medical help:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Upset stomach or vomiting
Back pain
Weight gain
Stomach pain
* Bruising
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unusual changes in mood or behavior (e.g., increased aggression, anger, irritability, hostility)
- Thoughts of harming yourself or others
- New or worsening depression or anxiety
- Panic attacks
- Restlessness or agitation
- Severe dizziness or loss of balance
- Extreme tiredness or sleepiness
- Blurred vision or double vision
- 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 the medications you are currently taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to ensure that this medication is safe to take with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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 the medications you are currently taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to ensure that this medication is safe to take with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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 impair your reactions, with your doctor beforehand.
Do not abruptly discontinue this medication without first consulting your doctor, as this may increase your risk of experiencing seizures. If it becomes necessary to stop taking 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 consequences such as head injuries and fractures. The risk of falls is particularly higher in older adults. 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, their effectiveness in preventing pregnancy may be reduced. In addition to your regular birth control method, consider using a condom as an extra precautionary measure during treatment with 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 are 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 impair your reactions, with your doctor beforehand.
Do not abruptly discontinue this medication without first consulting your doctor, as this may increase your risk of experiencing seizures. If it becomes necessary to stop taking 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 consequences such as head injuries and fractures. The risk of falls is particularly higher in older adults. 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, their effectiveness in preventing pregnancy may be reduced. In addition to your regular birth control method, consider using a condom as an extra precautionary measure during treatment with 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 are 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
- Agitation
- Vertigo
- Nausea
- Vomiting
- Decreased consciousness
- Coma
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive, as there is no specific antidote.
Drug Interactions
Major Interactions
- Carbamazepine (decreases perampanel levels)
- Phenytoin (decreases perampanel levels)
- Oxcarbazepine (decreases perampanel levels)
- Rifampin (decreases perampanel levels)
- St. John's Wort (decreases perampanel levels)
Moderate Interactions
- Hormonal contraceptives (perampanel may decrease efficacy of progestin-only contraceptives)
- Other CNS depressants (increased risk of sedation, dizziness, ataxia)
- Alcohol (increased risk of CNS depression and psychiatric adverse events)
Monitoring
Baseline Monitoring
Psychiatric history assessment
Rationale: To identify pre-existing conditions that may increase risk of behavioral/mood changes.
Timing: Prior to initiation
Liver function tests (LFTs)
Rationale: To establish baseline, especially in patients with pre-existing hepatic impairment.
Timing: Prior to initiation
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly during treatment
Target: Reduction in seizure frequency
Action Threshold: Lack of efficacy or worsening seizures may require dose adjustment or alternative therapy.
Behavioral and mood changes (e.g., aggression, hostility, irritability, suicidal ideation)
Frequency: Regularly, especially during titration and dose changes
Target: Absence of new or worsening psychiatric symptoms
Action Threshold: Emergence of significant behavioral changes requires immediate evaluation and consideration of dose reduction or discontinuation.
Dizziness, somnolence, gait disturbance
Frequency: Regularly, especially during titration
Target: Tolerable levels
Action Threshold: Severe or persistent symptoms may require dose reduction.
Symptom Monitoring
- Aggression
- Hostility
- Irritability
- Anger
- Suicidal ideation or behavior
- Dizziness
- Somnolence
- Fatigue
- Ataxia
- Gait disturbance
- Nausea
- Weight gain
Special Patient Groups
Pregnancy
Perampanel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is a pregnancy registry for women exposed to antiepileptic drugs during pregnancy.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show developmental toxicity (e.g., skeletal abnormalities, reduced fetal weight) at clinically relevant exposures.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data.
Lactation
Perampanel is excreted into human milk. Due to the long half-life and potential for serious adverse reactions in breastfed infants (e.g., sedation, irritability), 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 - possible adverse effects on infant; monitor for sedation, irritability, poor feeding).
Pediatric Use
Approved for focal-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. Safety and efficacy in children younger than 4 years (focal-onset) and younger than 7 years (primary generalized tonic-clonic) have not been established.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients may be more sensitive to adverse effects (e.g., dizziness, 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.
- Titration is crucial to minimize adverse effects, especially psychiatric and CNS-related ones.
- The Boxed Warning for psychiatric and behavioral adverse reactions is significant; patients and caregivers must be educated to monitor for these changes.
- Strong CYP3A4/5 inducers (e.g., carbamazepine, phenytoin, oxcarbazepine) can significantly reduce perampanel levels, potentially requiring higher perampanel doses.
- Perampanel may reduce the effectiveness of hormonal contraceptives, especially progestin-only types; advise alternative or additional birth control methods.
- Avoid or limit alcohol consumption due to increased risk of CNS depression and behavioral changes.
Alternative Therapies
- Levetiracetam
- Lamotrigine
- Topiramate
- Valproic acid
- Carbamazepine
- Oxcarbazepine
- Lacosamide
- Zonisamide
- Cenobamate
Cost & Coverage
Average Cost:
$1000 - $1500 per 30 tablets
Generic Available:
Yes
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 promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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, and the time it occurred.