Fycompa 2mg 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?
Fycompa 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 even if you feel well, unless your doctor or healthcare provider tells 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. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, skip it and take the next dose at your regular time. Do not take two doses at once 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 even if you feel well, unless your doctor or healthcare provider tells 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. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, skip it and take the next dose at your regular time. Do not take two doses at once or extra doses. If you miss more than one day of taking this medication, consult your doctor for guidance.
Lifestyle & Tips
- Do not stop taking Fycompa suddenly, as this can cause seizures to worsen or occur more frequently. Always talk to your doctor before making any changes to your dose.
- Avoid or limit alcohol consumption while taking Fycompa, as it can increase side effects like dizziness and drowsiness.
- Be aware that Fycompa can cause dizziness, drowsiness, and problems with balance or 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 with your doctor, as Fycompa can reduce the effectiveness of hormonal birth control.
- 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 orally once daily at bedtime. Titrate by 2 mg increments weekly based on response and tolerability. Maintenance: 4-12 mg orally once daily.
Dose Range:
2 - 12 mg
Condition-Specific Dosing:
partialOnsetSeizures:
Initial: 2 mg once daily. Maintenance: 4-12 mg once daily.
generalizedTonicClonicSeizures:
Initial: 2 mg once daily. Maintenance: 8-12 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
4 to less than 12 years (adjunctive therapy for partial-onset seizures): Initial: 2 mg once daily. Titrate by 2 mg increments weekly. Maintenance: 4-12 mg once daily. Dosing based on weight for some indications.
Adolescent:
12 years and older (adjunctive therapy for partial-onset seizures or generalized tonic-clonic seizures): Initial: 2 mg once daily. Titrate by 2 mg increments weekly. Maintenance: 4-12 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required.
Moderate:
No dosage adjustment required.
Severe:
Not recommended due to lack of data.
Dialysis:
Not recommended due to lack of data.
Hepatic Impairment:
Mild:
Initial: 2 mg once daily. Max: 8 mg once daily.
Moderate:
Initial: 2 mg once daily. Max: 6 mg once daily.
Severe:
Not recommended due to lack of 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 is implicated in the initiation and spread of seizures. By modulating AMPA receptor activity, perampanel reduces neuronal excitability, thereby decreasing 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 (apparent volume of distribution)
ProteinBinding:
95-96%
CnssPenetration:
Yes
Elimination:
HalfLife:
70-105 hours (approximately 3-4 days)
Clearance:
Not available (low clearance)
ExcretionRoute:
70% urine (primarily as metabolites), 30% feces (primarily as metabolites)
Unchanged:
Less than 4% (urine), less than 2% (feces)
Pharmacodynamics
OnsetOfAction:
Not precisely defined for seizure control, but clinical effects are observed with titration.
PeakEffect:
Not precisely defined for seizure control, related to steady-state concentrations achieved after multiple doses.
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 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
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 can occur 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
+ 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 any other symptoms that bother you or do not go away, contact your doctor:
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
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 can occur 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
+ 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 any other symptoms that bother you or do not go away, contact your doctor:
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)
- 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
- Unexplained bruising or bleeding
- Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
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. To ensure your safety, please 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
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so, given your unique health situation and medication regimen.
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. To ensure your safety, please 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
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so, given your unique health situation and medication regimen.
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. Additionally, consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
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.
Be aware that this medication can increase your risk of falling, which may lead to severe consequences such as head injuries and fractures. This risk is particularly higher in older adults. It is crucial 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, be aware that their effectiveness in preventing pregnancy may be reduced. Consider using an alternative form of birth control, such as condoms, in conjunction with your current birth control method and for at least one month after your last dose of this medication. 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 well-being of both 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. Additionally, consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
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.
Be aware that this medication can increase your risk of falling, which may lead to severe consequences such as head injuries and fractures. This risk is particularly higher in older adults. It is crucial 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, be aware that their effectiveness in preventing pregnancy may be reduced. Consider using an alternative form of birth control, such as condoms, in conjunction with your current birth control method and for at least one month after your last dose of this medication. 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 well-being of both you and your baby.
Overdose Information
Overdose Symptoms:
- Somnolence
- Irritability
- Aggression
- Vertigo
- Nausea
- Vomiting
- Fatigue
- Dizziness
- Headache
- Coma
What to Do:
There is no specific antidote for perampanel overdose. Treatment should be supportive and symptomatic. Consider activated charcoal if ingestion is recent. Monitor vital signs and cardiac rhythm. Contact a poison control center immediately (e.g., 1-800-222-1222 in the US).
Drug Interactions
Major Interactions
- Hormonal contraceptives (perampanel can decrease efficacy)
- Strong CYP3A4/3A5 inducers (e.g., carbamazepine, phenytoin, oxcarbazepine, rifampin - can significantly decrease perampanel levels)
Moderate Interactions
- Other CNS depressants (e.g., alcohol, opioids, benzodiazepines - increased risk of sedation, dizziness)
- Valproate (may decrease perampanel clearance slightly, but not clinically significant for perampanel dosing)
- Phenobarbital (CYP3A4 inducer, similar to other strong inducers but potentially less potent)
Monitoring
Baseline Monitoring
Baseline psychiatric assessment
Rationale: To identify pre-existing psychiatric conditions or risk factors for behavioral changes, aggression, or hostility.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, especially important for patients with hepatic impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Seizure frequency and characteristics
Frequency: Regularly throughout treatment, especially during titration.
Target: Reduction in seizure frequency or complete seizure control.
Action Threshold: Lack of efficacy or worsening seizures may require dose adjustment or alternative therapy.
Psychiatric and behavioral changes (e.g., aggression, hostility, irritability, suicidal ideation)
Frequency: Regularly, especially during titration and dose increases.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: Any new or worsening psychiatric symptoms, particularly aggression or suicidal ideation, require immediate evaluation and potential dose reduction or discontinuation.
Dizziness, somnolence, gait disturbance
Frequency: Regularly, especially during titration.
Target: Tolerable levels of side effects.
Action Threshold: Severe or persistent side effects may require dose reduction or discontinuation.
Symptom Monitoring
- Aggression
- Hostility
- Irritability
- Anger
- Suicidal thoughts or behavior
- Depression
- Anxiety
- Psychotic symptoms
- Dizziness
- Somnolence
- Fatigue
- Nausea
- Headache
- Weight gain
- Gait disturbance
- Falls
Special Patient Groups
Pregnancy
Perampanel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown 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, though human data are limited. Consider risks vs. benefits.
Second Trimester:
Continued monitoring for fetal development. Risk of adverse effects on fetal growth and development.
Third Trimester:
Potential for withdrawal symptoms in the neonate if exposed late in pregnancy. Monitor neonate for somnolence, poor feeding, and irritability.
Lactation
Perampanel is excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., somnolence, irritability, poor feeding), 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:
Moderate to High (L3). Potential for somnolence, irritability, and poor feeding in the infant due to long half-life and excretion into milk.
Pediatric Use
Approved for adjunctive treatment of partial-onset seizures in patients 4 years and older, and for primary generalized tonic-clonic seizures in patients 12 years and older. Dosing is weight-based for younger children. Psychiatric and behavioral adverse reactions may be more common in pediatric patients.
Geriatric Use
No specific dosage 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. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Perampanel has a very long half-life, allowing for once-daily dosing and slow titration. This also means that steady-state concentrations are reached slowly (over 2-3 weeks), and side effects may take time to resolve after discontinuation.
- The Black Box Warning for psychiatric and behavioral reactions is crucial. Counsel patients and caregivers thoroughly and monitor closely, especially during dose escalation.
- Patients should be advised about the potential for increased CNS depression when combining perampanel with alcohol or other CNS depressants.
- Due to its interaction with hormonal contraceptives, women of childbearing potential should be counseled on alternative or additional birth control methods.
- Weight gain is a common side effect; counsel patients on lifestyle modifications if this becomes an issue.
Alternative Therapies
- Levetiracetam (Keppra)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Valproate (Depakote)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Lacosamide (Vimpat)
- Brivaracetam (Briviact)
Cost & Coverage
Average Cost:
Varies, typically $1000-$1500 per 30 tablets
Insurance Coverage:
Tier 3 (Non-preferred Brand) or Tier 2 (Preferred Brand) depending on insurance plan
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. Be prepared to provide detailed information about the incident, including the medication taken, the quantity, 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. Be prepared to provide detailed information about the incident, including the medication taken, the quantity, and the time it occurred.