Fycompa 8mg 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
Category C
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 affecting a specific chemical in the brain that can cause seizures, helping to reduce how often they happen.
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 even if you feel well, unless your doctor or healthcare provider advises you to stop.
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 and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of local drug take-back programs.
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 medication, consult your doctor for guidance on how to proceed.
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 even if you feel well, unless your doctor or healthcare provider advises you to stop.
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 and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of local drug take-back programs.
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 medication, consult your doctor for guidance on how to proceed.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily at bedtime.
- Do not stop taking this medication suddenly without talking to your doctor, as this can cause seizures to worsen.
- Avoid alcohol while taking this medication, as it can increase side effects like dizziness and drowsiness.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness and sleepiness.
- Report any new or worsening mood changes, aggression, hostility, 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 increments weekly. Maintenance 8-12 mg once daily.
Dose Range:
2 - 12 mg
Condition-Specific Dosing:
Adjunctive therapy for focal-onset seizures (with or without secondary generalization):
Initial 2 mg once daily, titrate by 2 mg increments weekly to maintenance 8-12 mg once daily. Max 12 mg/day.
Adjunctive therapy for primary generalized tonic-clonic seizures:
Initial 2 mg once daily, titrate by 2 mg increments weekly to maintenance 8 mg once daily. Max 8 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For patients 4 years and older (FOS) or 7 years and older (PGTCS): Initial 2 mg once daily, titrate by 2 mg increments weekly. Maintenance dose depends on weight and indication (e.g., 4-12 mg/day for FOS, 4-8 mg/day for PGTCS).
Adolescent:
Same as adult dosing for patients 12 years and older. For patients 4 to less than 12 years, dosing is weight-based (e.g., 2-12 mg/day for FOS, 2-8 mg/day for PGTCS).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
Not recommended due to limited data.
Dialysis:
Not recommended due to limited data.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
Max dose 8 mg/day. Use with caution.
Severe:
Not recommended due to limited data.
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 post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system, and AMPA receptors mediate fast synaptic transmission. By modulating AMPA receptor activity, perampanel is thought to reduce neuronal hyperexcitability, thereby exerting its anticonvulsant effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
0.5-2.5 hours (median 1 hour)
FoodEffect:
Food does not affect the extent of absorption but may delay Tmax by 2-3 hours.
Distribution:
Vd:
Approximately 107 L
ProteinBinding:
95-96% (primarily to albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 105 hours (range 70-300 hours)
Clearance:
Approximately 12 mL/min
ExcretionRoute:
Mainly via metabolism followed by renal (70%) and fecal (30%) excretion.
Unchanged:
< 2% (renal)
Pharmacodynamics
OnsetOfAction:
Within days of reaching therapeutic levels (titration period)
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 reactions, including aggression, hostility, irritability, anger, and homicidal ideation and threats, have been reported in patients taking FYCOMPA. These reactions have been reported 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 and caregivers should be advised to look for signs of these reactions and to seek medical advice immediately 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
Feeling confused
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
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 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
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 any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Nausea 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
Feeling confused
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
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 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
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 any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Nausea 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)
- 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
- Unexplained skin rash or blistering
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 as a result of the allergy.
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 medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not 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 as a result of the allergy.
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 medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not 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 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 you need to stop taking this medication, your doctor will instruct you 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. 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 unintended pregnancy, use 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 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 you need to stop taking this medication, your doctor will instruct you 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. 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 unintended pregnancy, use 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
- Nausea
- Vomiting
- Somnolence
- Fatigue
- Ataxia
- Disorientation
- Coma
What to Do:
Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US) immediately. Seek emergency medical attention. There is no specific antidote; treatment is supportive.
Drug Interactions
Major Interactions
- Strong CYP3A4/CYP2B6 inducers (e.g., carbamazepine, phenytoin, oxcarbazepine, rifampin): May decrease perampanel concentrations, requiring higher perampanel doses.
- Hormonal contraceptives: Perampanel may decrease the effectiveness of hormonal contraceptives (e.g., levonorgestrel-containing products).
Monitoring
Baseline Monitoring
Psychiatric history assessment
Rationale: To identify pre-existing conditions that may increase risk of behavioral/psychiatric adverse events.
Timing: Prior to initiation
Liver function tests (LFTs)
Rationale: To assess baseline hepatic function, especially if hepatic impairment is suspected or patient has history of liver disease.
Timing: Prior to initiation
Routine Monitoring
Behavioral and mood changes
Frequency: Regularly, especially during titration and dose adjustments
Target: Absence of new or worsening aggression, hostility, irritability, anger, suicidal ideation, or homicidal ideation.
Action Threshold: Prompt evaluation and dose adjustment/discontinuation if severe or persistent changes occur.
Seizure frequency and severity
Frequency: Regularly
Target: Reduction in seizure frequency and/or severity.
Action Threshold: Adjust dose if inadequate seizure control or intolerable side effects.
Dizziness, somnolence, gait disturbance
Frequency: Regularly, especially during titration
Target: Tolerance of side effects.
Action Threshold: Consider dose reduction or slower titration if severe or persistent.
Symptom Monitoring
- Aggression
- Hostility
- Irritability
- Anger
- Suicidal ideation or behavior
- Homicidal ideation or behavior
- Depression
- Anxiety
- Psychotic symptoms
- Dizziness
- Somnolence
- Fatigue
- Ataxia
- Gait disturbance
- Nausea
- Weight gain
Special Patient Groups
Pregnancy
Perampanel is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data from animal studies show developmental toxicity (e.g., skeletal abnormalities, reduced fetal weight) at clinically relevant exposures.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations based on animal data.
Second Trimester:
Potential for developmental effects based on animal data.
Third Trimester:
Potential for developmental effects based on animal data.
Lactation
Perampanel is excreted into human milk. Due to the 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 concern) - Potential for sedation, irritability, and other CNS effects in the infant due to long half-life and excretion into milk.
Pediatric Use
Approved for adjunctive treatment of focal-onset seizures in patients 4 years and older, and primary generalized tonic-clonic seizures in patients 7 years and older. Dosing is weight-based for younger children. Close monitoring for behavioral and psychiatric adverse events is crucial.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the CNS depressant effects (dizziness, somnolence, ataxia) and should be monitored closely. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Perampanel has a long half-life, allowing for once-daily dosing, typically at bedtime to mitigate CNS side effects.
- The Black Box Warning for psychiatric/behavioral changes is significant; counsel patients and caregivers thoroughly and monitor closely, especially during titration.
- Enzyme-inducing AEDs (carbamazepine, phenytoin, oxcarbazepine) can significantly reduce perampanel levels, often requiring higher perampanel doses.
- Perampanel can reduce the effectiveness of hormonal contraceptives; advise patients on alternative birth control methods.
- Titrate slowly to minimize dose-related adverse effects like dizziness and somnolence.
Alternative Therapies
- Levetiracetam (Keppra)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Valproic acid (Depakote)
- Lacosamide (Vimpat)
- Brivaracetam (Briviact)
- Cenobamate (Xcopri)
Cost & Coverage
Average Cost:
$1000 - $1500 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 3 (Non-preferred Brand) or Tier 2 (Preferred Brand) depending on formulary.
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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.