Fycompa 6mg 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 help control certain types of seizures in people with epilepsy. It works by calming overactive brain signals that can cause seizures. It's usually taken once a day at bedtime.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take this medication at bedtime as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. 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. 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. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you miss more than one day of taking your medication, consult with your doctor for further guidance.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take this medication at bedtime as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. 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. 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. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you miss more than one day of taking your medication, consult with your doctor for further guidance.
Lifestyle & Tips
- Take Fycompa exactly as prescribed, usually once daily at bedtime.
- Do not stop taking Fycompa suddenly without talking to your doctor, as this can cause seizures to worsen.
- Avoid or limit alcohol consumption while taking Fycompa, as it can increase side effects like dizziness and drowsiness.
- Be aware that Fycompa can cause serious mood or behavior changes, including aggression, hostility, and thoughts of harming yourself or others. Report any such changes to your doctor immediately.
- Fycompa can cause dizziness and drowsiness, especially when you first start taking it or when the dose is increased. Avoid driving or operating machinery until you know how it affects you.
- If you are taking birth control pills, especially progestin-only pills, discuss this with your doctor as Fycompa may make them less effective.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 2 mg orally once daily at bedtime, titrated weekly by 2 mg/day. Maintenance dose typically 4-12 mg/day for partial-onset seizures (POS) and 8 mg/day for primary generalized tonic-clonic (PGTC) seizures.
Dose Range:
2 - 12 mg
Condition-Specific Dosing:
partialOnsetSeizures:
Maintenance 4-12 mg/day
primaryGeneralizedTonicClonicSeizures:
Maintenance 8 mg/day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For patients 4 years and older: Initial 2 mg orally once daily at bedtime, titrated weekly by 2 mg/day based on weight. Maintenance dose varies by weight (e.g., 4-12 mg/day for β₯30 kg, 4-8 mg/day for 20 to <30 kg, 2-6 mg/day for <20 kg).
Adolescent:
Same as adult dosing for patients 12 years and older.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
Not recommended due to lack of data.
Dialysis:
Not recommended due to lack of data.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
Maximum dose of 8 mg/day.
Severe:
Not recommended due to lack of data.
Pharmacology
Mechanism of Action
Perampanel is a selective, non-competitive antagonist of the ionotropic Ξ±-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 excitability, thereby decreasing seizure activity.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
0.5-2.5 hours (fasted state)
FoodEffect:
Food increases Tmax by 2-3 hours but does not affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 107 L
ProteinBinding:
>95% (primarily to albumin and alpha1-acid glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 70-105 hours (can be shorter, 25-46 hours, with concomitant enzyme-inducing AEDs)
Clearance:
Approximately 0.5 L/hr (can be increased by enzyme inducers)
ExcretionRoute:
Approximately 70% in urine (as metabolites), 30% in feces (unchanged and metabolites)
Unchanged:
Less than 5% excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Not precisely quantified for antiepileptic effect, but plasma concentrations reach steady state in 2-3 weeks with once-daily dosing.
PeakEffect:
Correlates with steady-state plasma concentrations.
DurationOfAction:
Due to long half-life, effects persist for several days after discontinuation.
Safety & Warnings
BLACK BOX WARNING
Serious psychiatric and behavioral 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. Advise patients and caregivers to be alert for these reactions and to seek medical advice immediately if they occur. Closely monitor patients for these reactions, especially during the titration period and at higher doses. If these reactions occur, consider dose reduction or discontinuation of Fycompa.
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
Change 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 side effect. 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
+ Change in the amount of urine passed
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ 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. Many people may not experience any side effects or may 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 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 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
Change 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 side effect. 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
+ Change in the amount of urine passed
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ 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. Many people may not experience any side effects or may 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 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:
- Unusual changes in mood or behavior (e.g., increased aggression, anger, irritability)
- 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 weakness
- New or worsening seizures
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 a history of kidney disease or liver disease, as these conditions may affect how your body processes the 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 medications you are taking
Any natural products or vitamins you are using
* Any existing health problems
This information will help your doctor determine whether it is safe for you to take this medication, considering your unique health profile and potential interactions with other substances. 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 symptoms you experienced.
If you have a history of kidney disease or liver disease, as these conditions may affect how your body processes the 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 medications you are taking
Any natural products or vitamins you are using
* Any existing health problems
This information will help your doctor determine whether it is safe for you to take this medication, considering your unique health profile and potential interactions with other substances. 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 discontinue this medication without first consulting your doctor, as this may increase your risk of experiencing seizures. If you need 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 complications such as head injuries and fractures. Older adults are at a higher risk of falls, so it is vital to discuss this with your doctor.
If you are 65 years or older, exercise caution when taking 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, be aware that 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 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 cause drowsiness, 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 you need 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 complications such as head injuries and fractures. Older adults are at a higher risk of falls, so it is vital to discuss this with your doctor.
If you are 65 years or older, exercise caution when taking 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, be aware that 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 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
- Reduced consciousness
- Coma
What to Do:
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. There is no specific antidote. Treatment is supportive and symptomatic.
Drug Interactions
Major Interactions
- Carbamazepine (decreases perampanel levels)
- Phenytoin (decreases perampanel levels)
- Oxcarbazepine (decreases perampanel levels)
- Rifampin (decreases perampanel levels)
- Oral contraceptives (perampanel may decrease efficacy of progestin-only contraceptives)
Monitoring
Baseline Monitoring
Baseline psychiatric assessment
Rationale: To identify pre-existing psychiatric conditions that may be exacerbated by perampanel, given the risk of serious psychiatric and behavioral reactions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly, at each follow-up visit.
Target: Reduction in seizure frequency, improved seizure control.
Action Threshold: Lack of efficacy or worsening seizures may require dose adjustment or alternative therapy.
Psychiatric and behavioral symptoms (e.g., aggression, hostility, irritability, anger, homicidal ideation/threats, suicidal ideation)
Frequency: Regularly, at each follow-up visit, and instruct patients/caregivers to report immediately.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: Emergence or worsening of symptoms requires immediate medical evaluation and consideration of dose reduction or discontinuation.
Dizziness, somnolence, gait disturbance
Frequency: Regularly, especially during titration.
Target: Tolerance of side effects.
Action Threshold: Severe or intolerable side effects may require dose reduction or slower titration.
Symptom Monitoring
- Aggression
- Hostility
- Irritability
- Anger
- Homicidal ideation or threats
- Suicidal ideation or behavior
- Depression
- Anxiety
- Psychosis
- Dizziness
- Somnolence
- Fatigue
- Ataxia
- Gait disturbance
- Nausea
- Weight gain
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. Data from pregnancy registries are limited but suggest potential for adverse outcomes. Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally, the first trimester is a critical period for organogenesis. Potential for increased risk of major congenital malformations cannot be excluded.
Second Trimester:
Not specifically studied, but continued exposure may impact fetal development.
Third Trimester:
Not specifically studied, but continued exposure may impact fetal development and neonatal adaptation.
Lactation
Perampanel is excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the motherβs clinical need for Fycompa, and any potential adverse effects on the breastfed infant from Fycompa or from the underlying maternal condition. Monitor breastfed infants for sedation, irritability, and poor feeding.
Infant Risk:
Moderate risk (L3). Potential for sedation, irritability, and poor feeding in the infant.
Pediatric Use
Approved for children 4 years and older for partial-onset seizures and 12 years and older for primary generalized tonic-clonic seizures. Dosing is weight-based for younger children. Safety and efficacy in children younger than 4 years have not been established.
Geriatric Use
No specific dose adjustment is required based on age. 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 very 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 Black Box Warning for serious psychiatric and behavioral reactions (including aggression and homicidal ideation) is significant and requires careful patient and caregiver counseling and monitoring.
- Enzyme-inducing AEDs (e.g., carbamazepine, phenytoin, oxcarbazepine) can significantly reduce perampanel levels, requiring higher perampanel doses.
- Perampanel can reduce the effectiveness of progestin-only oral contraceptives; advise alternative or additional birth control methods.
- Alcohol should be avoided due to additive CNS depressant effects.
- Weight gain is a common side effect that should be monitored.
Alternative Therapies
- Levetiracetam (Keppra)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Valproic Acid (Depakote)
- Lacosamide (Vimpat)
- Zonisamide (Zonegran)
- Cenobamate (Xcopri)
Cost & Coverage
Average Cost:
Varies widely, typically $1000-$1500 per 30 tablets (6mg)
Generic Available:
Yes
Insurance Coverage:
Tier 3 (Non-preferred Brand) or Tier 2 (Preferred Brand) for brand, Tier 1 (Preferred Generic) for generic. Requires prior authorization for some plans.
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. If you have any questions or concerns about this medication, don't hesitate to consult 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. If you have any questions or concerns about this medication, don't hesitate to consult 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.