Fycompa 4mg Tablets

Manufacturer CATALYST PHARMACEUTICALS Active Ingredient Perampanel Tablets(per AM pa nel) Pronunciation per-AM-pa-nel
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.
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Drug Class
Antiepileptic Drug (AED)
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Pharmacologic Class
Selective, non-competitive AMPA receptor antagonist
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Pregnancy Category
Category C
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FDA Approved
Oct 2012
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Perampanel is a medication used to treat certain types of seizures (epilepsy). It works by calming overactive brain signals that can cause seizures. It's taken once a day, usually at bedtime.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to 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 by your doctor or other healthcare provider. Continue taking the medication even if you start to feel well, as instructed by your doctor.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding bathrooms. 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, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs.

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.
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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 alcohol 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, anger, and thoughts of harming yourself or others. Report any such changes to your doctor immediately.
  • Fycompa can cause dizziness, drowsiness, and problems with balance. Avoid driving or operating machinery until you know how this medication affects you.
  • If you are taking oral contraceptives, discuss with your doctor as Fycompa may reduce their effectiveness, especially at higher doses.

Dosing & Administration

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Adult Dosing

Standard Dose: Adjunctive therapy: Initial 2 mg once daily at bedtime, titrate by 2 mg/day increments at weekly intervals based on response and tolerability. Maintenance 4-12 mg once daily. Monotherapy: Initial 2 mg once daily at bedtime, titrate by 2 mg/day increments at weekly intervals. Maintenance 4-8 mg once daily.
Dose Range: 2 - 12 mg

Condition-Specific Dosing:

adjunctive: 4-12 mg once daily
monotherapy: 4-8 mg once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 4 to <12 years: Initial 2 mg once daily at bedtime, titrate by 2 mg/day increments at weekly intervals. Maintenance 4-12 mg once daily (adjunctive) or 4-8 mg once daily (monotherapy), based on weight and response. Max 12 mg/day.
Adolescent: 12 years and older: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment required.
Moderate: No dose adjustment required.
Severe: Not recommended due to lack of data.
Dialysis: Not recommended due to lack of data.

Hepatic Impairment:

Mild: No dose adjustment required.
Moderate: Initial 2 mg once daily at bedtime, titrate by 2 mg/day increments at weekly intervals. Max 8 mg once daily.
Severe: Not recommended due to lack of data.

Pharmacology

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Mechanism of Action

Perampanel is a selective, non-competitive antagonist of the ionotropic Îą-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on postsynaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in the initiation and propagation of seizures. By blocking AMPA receptors, perampanel reduces neuronal excitability, thereby exerting its anticonvulsant effect.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 100%
Tmax: 0.5 to 2.5 hours (median)
FoodEffect: Food does not affect the extent of absorption, but may prolong Tmax by 1 hour.

Distribution:

Vd: Approximately 107 L
ProteinBinding: 95-96%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 105 hours (range 70-300 hours)
Clearance: Approximately 12 mL/min
ExcretionRoute: Approximately 70% in urine (as metabolites), 30% in feces (as metabolites)
Unchanged: <2% in urine, <7% in feces
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Pharmacodynamics

OnsetOfAction: Not precisely quantified for seizure control, but therapeutic effects are observed with titration.
PeakEffect: Steady-state concentrations are reached within 2-3 weeks with once-daily dosing.
DurationOfAction: Due to its long half-life, effects persist for several days after discontinuation.

Safety & Warnings

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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. Monitor patients for these reactions and consider dose reduction or discontinuation if they occur.
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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 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:

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.
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Seek Immediate Medical Attention If You Experience:

  • Unusual changes in mood or behavior (e.g., new or worsening aggression, anger, irritability, hostility)
  • Thoughts of harming yourself or others (homicidal ideation)
  • Thoughts of suicide or self-harm
  • New or worsening depression or anxiety
  • Panic attacks
  • Restlessness or agitation
  • Severe dizziness or loss of balance
  • Extreme tiredness or weakness
  • Unexplained skin rash or allergic reaction
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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 the 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, tell your doctor and pharmacist about:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems, as they may interact with this medication

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.
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Precautions & Cautions

It is essential to inform all of 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 it is necessary to stop taking this medication, your doctor will provide guidance on how to gradually taper off the dosage.

This medication may increase your risk of falling, which can lead to severe consequences such as head injuries and fractures. 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.

It is also important to note that birth control pills and other hormone-based birth control products containing levonorgestrel may be less effective in preventing pregnancy. If you are using a birth control product with levonorgestrel, consider using an additional form of birth control, such as a condom, during treatment and for one month after your last dose of this medication. If you have any questions or concerns, consult your doctor.

Additionally, if you are pregnant, plan to become pregnant, or are breastfeeding, you should discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Irritability
  • Aggression
  • Nausea
  • Vomiting
  • Ataxia (loss of coordination)
  • Somnolence (extreme drowsiness)
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. There is no specific antidote; treatment is supportive.

Drug Interactions

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Major Interactions

  • Strong CYP3A4/5 inducers (e.g., Carbamazepine, Phenytoin, Oxcarbazepine): Significantly decrease perampanel plasma concentrations, requiring higher perampanel doses.
  • Rifampin: May significantly decrease perampanel plasma concentrations.
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Moderate Interactions

  • Oral Contraceptives (Ethinyl Estradiol): Perampanel 12 mg/day may decrease ethinyl estradiol levels, potentially reducing contraceptive efficacy.
  • Levonorgestrel: Perampanel 12 mg/day may decrease levonorgestrel levels.
  • Other CNS depressants (e.g., Alcohol, Opioids, Benzodiazepines): May enhance CNS depressant effects (drowsiness, dizziness, ataxia).
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Minor Interactions

  • Other AEDs (e.g., Valproate, Levetiracetam): Generally no significant pharmacokinetic interaction, but additive CNS effects are possible.

Monitoring

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Baseline Monitoring

Psychiatric history and current mental status

Rationale: Perampanel carries a Black Box Warning for serious psychiatric and behavioral reactions, including aggression, hostility, irritability, and homicidal ideation/threats. Baseline assessment helps identify risk factors and monitor for changes.

Timing: Prior to initiation of therapy.

Renal and Hepatic function tests (e.g., SCr, ALT, AST, bilirubin)

Rationale: To establish baseline function and guide dosing adjustments in patients with hepatic impairment; not recommended in severe renal/hepatic impairment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Monitoring for psychiatric and behavioral changes (e.g., aggression, hostility, irritability, anger, homicidal ideation/threats, suicidal ideation)

Frequency: Regularly throughout treatment, especially during titration and dose increases.

Target: Absence of new or worsening symptoms.

Action Threshold: Promptly evaluate any new or worsening psychiatric symptoms; consider dose reduction or discontinuation.

Seizure frequency and severity

Frequency: Regularly, as clinically indicated.

Target: Reduction or elimination of seizures.

Action Threshold: Lack of efficacy may warrant dose increase or alternative therapy.

Dizziness, somnolence, gait disturbance

Frequency: Regularly, especially during titration.

Target: Tolerable levels of side effects.

Action Threshold: Significant or intolerable side effects may require dose reduction or slower titration.

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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

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Pregnancy

Perampanel is classified as Pregnancy Category C. Studies in animals have shown adverse effects on fetal development. 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.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of major congenital malformations based on animal data; human data are limited.
Second Trimester: Limited human data; animal studies suggest potential for developmental toxicity.
Third Trimester: Limited human data; animal studies suggest potential for developmental toxicity.
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Lactation

Perampanel is excreted into breast milk. The half-life is long, leading to prolonged exposure in the infant. Due to the potential for serious adverse reactions in breastfed infants (e.g., sedation, 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 risk (L3). Potential for sedation, irritability, and other CNS effects in the infant. Monitor breastfed infants for adverse effects.
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Pediatric Use

Approved for adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients 4 years of age and older, and for monotherapy of partial-onset seizures with or without secondarily generalized seizures in patients 4 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.

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Geriatric Use

No specific dose 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.

Clinical Information

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Clinical Pearls

  • Perampanel has a very long half-life (around 105 hours), allowing for once-daily dosing and slow titration. This also means side effects can be prolonged after discontinuation.
  • The Black Box Warning for psychiatric and behavioral reactions is significant; patients and caregivers must be thoroughly counselled on these risks and instructed to report any changes immediately.
  • Titration should be slow (2 mg increments weekly) to minimize CNS side effects like dizziness and somnolence.
  • Patients on oral contraceptives should be advised about potential reduced efficacy, especially at higher perampanel doses (12 mg/day), and consider alternative or additional birth control methods.
  • Avoid abrupt discontinuation, as this can increase seizure frequency or severity.
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Alternative Therapies

  • Levetiracetam (Keppra)
  • Lamotrigine (Lamictal)
  • Topiramate (Topamax)
  • Valproate (Depakote)
  • Carbamazepine (Tegretol)
  • Oxcarbazepine (Trileptal)
  • Lacosamide (Vimpat)
  • Cenobamate (Xcopri)
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Cost & Coverage

Average Cost: Varies widely, typically $1000-$1500+ per 30 tablets (4mg)
Generic Available: Yes
Insurance Coverage: Tier 3 (Non-preferred Brand) or Tier 2 (Preferred Brand) for brand; Tier 1 (Preferred Generic) for generic.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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.