Fycompa 0.5mg/ml Suspension 340ml
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 medicine 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 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. If the adapter is not already attached to the bottle, prepare it according to the instructions you received or as described in the package insert.
Take this medication at bedtime.
Before using, shake the bottle well to ensure the medication is properly mixed.
When measuring a liquid dose, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.
Do not use a household teaspoon or tablespoon to measure your dose, as this can lead to taking too much medication.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, avoiding the bathroom.
Do not freeze the medication.
* After opening, discard any unused portion after 90 days.
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 medication, consult your doctor for guidance.
To use this medication correctly, follow your doctor's instructions and read all the information provided. If the adapter is not already attached to the bottle, prepare it according to the instructions you received or as described in the package insert.
Take this medication at bedtime.
Before using, shake the bottle well to ensure the medication is properly mixed.
When measuring a liquid dose, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.
Do not use a household teaspoon or tablespoon to measure your dose, as this can lead to taking too much medication.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, avoiding the bathroom.
Do not freeze the medication.
* After opening, discard any unused portion after 90 days.
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 medication, consult your doctor for guidance.
Lifestyle & Tips
- Take Fycompa exactly as prescribed, usually once daily at bedtime.
- Do not stop taking Fycompa suddenly, as this can increase the risk of seizures.
- Avoid or limit alcohol consumption, as it can increase side effects like dizziness and drowsiness.
- Be aware that Fycompa can cause dizziness, drowsiness, and problems with balance, especially when starting the medication or increasing the dose. Avoid driving or operating machinery until you know how it affects you.
- Report any new or worsening mood changes, aggression, hostility, or thoughts of self-harm to your doctor immediately.
- If you are taking hormonal birth control, discuss with your doctor as Fycompa may make it less effective, especially at higher doses.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 2 mg orally once daily at bedtime. Titrate by 2 mg/day increments at weekly intervals. Maintenance: 4-12 mg orally once daily at bedtime.
Dose Range:
2 - 12 mg
Condition-Specific Dosing:
Focal Onset Seizures (Adjunctive Therapy):
Initial: 2 mg/day, titrate to 4-12 mg/day. Max: 12 mg/day.
Primary Generalized Tonic-Clonic Seizures (Adjunctive Therapy):
Initial: 2 mg/day, titrate to 8 mg/day. Max: 8 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (approved for children 4 years and older for focal onset seizures)
Child:
Focal Onset Seizures (4 to <12 years): Initial 2 mg/day, titrate by 2 mg/day increments at weekly intervals based on response and tolerability. Maintenance: 4-12 mg/day (weight-based dosing may apply, refer to prescribing information for specific weight bands). Primary Generalized Tonic-Clonic Seizures (12 to <18 years): Initial 2 mg/day, titrate to 8 mg/day. Max: 8 mg/day.
Adolescent:
Focal Onset Seizures (12 to <18 years): Initial 2 mg/day, titrate to 4-12 mg/day. Max: 12 mg/day. Primary Generalized Tonic-Clonic Seizures (12 to <18 years): Initial 2 mg/day, titrate to 8 mg/day. Max: 8 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
Use with caution; limited data. Not recommended for patients with severe renal impairment (CrCl <30 mL/min) or those on dialysis.
Dialysis:
Not recommended due to limited data and high protein binding.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
Initial dose of 2 mg/day. Max dose of 6 mg/day. Titrate with caution.
Severe:
Not recommended due to limited clinical experience and potential for increased exposure.
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 decreasing seizure activity.
Pharmacokinetics
Absorption:
Bioavailability:
Nearly 100%
Tmax:
0.5-2.5 hours (oral suspension may have slightly different Tmax compared to tablets)
FoodEffect:
Food delays Tmax (by 2-3 hours) but does not affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 100 L
ProteinBinding:
95-96%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 70-105 hours (can be significantly shorter, e.g., 25-46 hours, when co-administered with enzyme-inducing AEDs)
Clearance:
Approximately 12 mL/min (can be significantly increased by enzyme-inducing AEDs)
ExcretionRoute:
Approximately 70% via urine (as metabolites), approximately 30% via feces (as metabolites).
Unchanged:
<0.2%
Pharmacodynamics
OnsetOfAction:
Not precisely defined for seizure control, but clinical effects are observed with titration.
PeakEffect:
Steady-state concentrations are reached within 2-3 weeks with once-daily dosing.
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 prior psychiatric history, and some patients have required hospitalization. Suicidal ideation and behavior have also been reported. Monitor patients for these reactions and consider dose reduction or discontinuation 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
+ 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 or seek medical help:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Upset stomach or vomiting
Back pain
Weight gain
Stomach pain
* Bruising
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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
+ 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 or seek medical help:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Upset stomach or vomiting
Back pain
Weight gain
Stomach pain
* Bruising
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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
- Agitation or restlessness
- Severe dizziness or loss of balance
- Extreme tiredness or weakness
- Blurred or double vision
- Severe nausea or vomiting
- Unexplained bruising or bleeding
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 safe treatment, 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
* All your health problems, including any pre-existing conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the best possible treatment outcome.
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 safe treatment, 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
* All your health problems, including any pre-existing conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the best possible treatment outcome.
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 activities that require alertness, wait until you understand how this drug affects you. Additionally, consult with your doctor before consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may impair your reactions.
To minimize the risk of seizures, do not abruptly discontinue this medication without first consulting your doctor. If you need to stop taking this drug, your doctor will instruct you on how to gradually taper off the dosage.
Be aware that this medication increases the risk of falls, which can 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. As a precaution, 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 questions or concerns, consult with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor to ensure the well-being of both you and your baby.
To minimize the risk of seizures, do not abruptly discontinue this medication without first consulting your doctor. If you need to stop taking this drug, your doctor will instruct you on how to gradually taper off the dosage.
Be aware that this medication increases the risk of falls, which can 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. As a precaution, 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 questions or concerns, consult with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the 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
- Ataxia
- Confusion
- Disorientation
What to Do:
Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention. There is no specific antidote for perampanel overdose. Treatment is supportive and symptomatic.
Drug Interactions
Major Interactions
- Carbamazepine (significant decrease in perampanel levels)
- Phenytoin (significant decrease in perampanel levels)
- Oxcarbazepine (significant decrease in perampanel levels)
- Rifampin (expected significant decrease in perampanel levels)
- St. John's Wort (expected significant decrease in perampanel levels)
Moderate Interactions
- Oral contraceptives (may reduce efficacy of hormonal contraceptives, particularly progestin-only)
- Alcohol (increased CNS depressant effects)
- Other CNS depressants (e.g., opioids, benzodiazepines, sedating antihistamines, tricyclic antidepressants - increased risk of somnolence, dizziness, ataxia)
- Levonorgestrel (reduced efficacy when co-administered with perampanel at doses >8 mg/day)
Monitoring
Baseline Monitoring
Baseline psychiatric assessment
Rationale: To identify pre-existing psychiatric conditions or risk factors for behavioral changes, aggression, or suicidal ideation.
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 may warrant dose increase or alternative therapy; worsening seizures require re-evaluation.
Psychiatric and behavioral symptoms (e.g., aggression, hostility, irritability, anger, suicidal ide ideation/behavior, depression)
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 dose reduction, discontinuation, or psychiatric consultation.
Dizziness, somnolence, gait disturbance
Frequency: Regularly, especially during titration.
Target: Tolerable levels of side effects.
Action Threshold: Severe or persistent symptoms may require dose reduction or discontinuation.
Symptom Monitoring
- Aggression
- Hostility
- Irritability
- Anger
- Suicidal thoughts or behavior
- Depression
- Anxiety
- Paranoia
- Psychosis
- Dizziness
- Somnolence
- Fatigue
- Ataxia (loss of coordination)
- 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. Patients should be enrolled in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant while taking perampanel.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations based on animal studies, though human data are limited.
Second Trimester:
Not specifically studied, but continued exposure carries potential risks.
Third Trimester:
Not specifically studied, but continued exposure carries potential risks.
Lactation
Perampanel is excreted into human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother and the potential adverse effects on the infant. Monitor breastfed infants for somnolence, irritability, and poor feeding.
Infant Risk:
L3 (Moderately Safe) - Potential for infant adverse effects (e.g., sedation) due to drug excretion in milk, but benefits of breastfeeding may outweigh risks in some cases. Monitor infant closely.
Pediatric Use
Approved for adjunctive treatment of focal onset seizures in patients 4 years of age and older, and for adjunctive treatment of primary generalized tonic-clonic seizures in patients 12 years of age and older. Dosing is weight-based for younger children. Safety and efficacy in patients 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 long half-life, allowing for once-daily dosing and making it less prone to missed doses causing immediate withdrawal seizures.
- The Black Box Warning for psychiatric and behavioral reactions is significant; thoroughly counsel patients and caregivers and monitor closely, especially during titration.
- Dose adjustments are crucial when co-administering with enzyme-inducing AEDs (e.g., carbamazepine, phenytoin, oxcarbazepine) as they significantly reduce perampanel levels.
- Titrate slowly to minimize CNS side effects like dizziness and somnolence.
- The oral suspension formulation is useful for patients who have difficulty swallowing tablets or require precise dose adjustments.
- Advise patients about potential weight gain, which is a common side effect with long-term use of AEDs, including perampanel.
Alternative Therapies
- Levetiracetam
- Lamotrigine
- Topiramate
- Valproic acid
- Zonisamide
- Lacosamide
- Brivaracetam
- Cenobamate
Cost & Coverage
Average Cost:
Varies, typically $1000-$1500+ per 340ml bottle (0.5mg/ml)
Insurance Coverage:
Tier 3 or 4 (Non-preferred Brand)
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 patient fact sheet that provides crucial information. 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 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, and the time it occurred.