Fycompa 4mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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.
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).
Minor Interactions
- Other AEDs (e.g., Valproate, Levetiracetam): Generally no significant pharmacokinetic interaction, but additive CNS effects are possible.
Monitoring
Baseline Monitoring
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.
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.
Routine Monitoring
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.
Frequency: Regularly, as clinically indicated.
Target: Reduction or elimination of seizures.
Action Threshold: Lack of efficacy may warrant dose increase or alternative therapy.
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.
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
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:
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.
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.
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
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.
Alternative Therapies
- Levetiracetam (Keppra)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Valproate (Depakote)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Lacosamide (Vimpat)
- Cenobamate (Xcopri)