Perampanel

What is Perampanel?

• Perampanel (FYCOMPA), a non-competitive AMPA glutamate receptor antagonist used as an anticonvulsant in the therapy of partial onset seizures.

Perampanel

Perampanel molecule ball

What are the uses of this medicine?

FYCOMPA is a prescription medicine used:

• to treat partial-onset seizures with or without secondarily generalized seizures in people with epilepsy who are 4 years of age and older.
• with other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older.

How does this medicine work?

• Perampanel (per am' pan el) is a glutamate receptor antagonist that is used to treat severe or refractory partial onset seizures.
• Perampanel binds to the alpha-amino-3-hydroxyl-5-methyl-4-isooxazole-propionate receptor (AMPAR) for glutamate, a major central nervous system excitatory neurotransmitter.
• The inhibition of the AMPAR leads to reduction in seizure activity in animal models as well as in patients with difficult to control seizures.
• In several large, prelicensure randomized controlled trials, addition of perampanel to conventional anticonvulsant medications led to improved control of epilepsy attributed to partial onset seizures.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Use of FYCOMPA with contraceptives containing levonorgestrel may render them less effective. Additional non-hormonal forms of contraception are recommended.
• The starting doses for FYCOMPA should be increased in the presence of moderate or strong CYP3A4 inducers (including carbamazepine, phenytoin, or oxcarbazepine).
• The concomitant use of FYCOMPA and CNS depressants including alcohol may increase CNS depression.

Is this medicine FDA approved?

• Perampanel was approved for use in the United States in 2012 as an anticonvulsant to be used in combination with other agents as adjunctive therapy of partial onset seizures.

How should this medicine be used?

Recommended dosage: Dosage for Partial-Onset Seizures:

• The recommended starting dosage of FYCOMPA in adults and pediatric patients 4 years of age and older is 2 mg once daily taken orally at bedtime.
• Increase dosage no more frequently than at weekly intervals by increments of 2 mg once daily based on individual clinical response and tolerability.
• May increase dose based on clinical response and tolerability by increments of 2 mg once daily no more frequently than at weekly intervals

Recommended maintenance dose in monotherapy or adjunctive therapy for partial-onset seizures: 8 mg to 12 mg once daily at bedtime

Dosage for Primary Generalized Tonic-Clonic Seizures:

• The recommended starting dosage of FYCOMPA in adults and pediatric patients 12 years of age and older is 2 mg once daily taken orally at bedtime.
• Increase dosage no more frequently than at weekly intervals by increments of 2 mg once daily based on individual clinical response and tolerability.

Recommended maintenance dose in adjunctive therapy for primary generalized tonic-clonic seizures:

• 8 mg once daily at bedtime

Dosage Modifications with Concomitant Use of Moderate or Strong CYP3A4 Enzyme Inducers:

• Increase dosage by increments of 2 mg once daily based on individual clinical response and tolerability, no more frequently than at weekly intervals.
• A maintenance dose has not been established in clinical trials.
• The highest dose studied in patients on concomitant enzyme-inducing AEDs was 12 mg once daily.

Dosage Adjustment in Patients with Hepatic Impairment

• In patients with mild and moderate hepatic impairment, the starting dose of FYCOMPA is 2 mg once daily.
• Increase dosage by increments of 2 mg once daily no more frequently than every 2 weeks.
• The maximum recommended daily dose is 6 mg for patients with mild hepatic impairment and 4 mg for patients with moderate hepatic impairment.

Administration:

• Take FYCOMPA exactly as your healthcare provider tells you. Your healthcare provider will tell you how much FYCOMPA to take and when to take it. FYCOMPA is usually taken 1 time a day at bedtime.
• Your healthcare provider may change the dose. Do not change the dose without talking to your healthcare provider.
• If you take FYCOMPA Oral Suspension, shake the bottle well before you take each dose.
• Measure the dose of FYCOMPA Oral Suspension using the bottle adapter and dosing syringes provided. Do not use a household teaspoon.
• Talk to your healthcare provider about what to do if you miss more than 1 dose of FYCOMPA.
• If you take too much FYCOMPA, call your local Poison Control Center or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg
• Oral Suspension: 0.5 mg/mL

This medicine is available in fallowing brand namesː

• FYCOMPA

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• sleepiness
• tiredness
• irritability
• falls
• nausea and vomiting
• weight gain
• vertigo (sense of spinning)
• problems walking normally
• problems with muscle coordination
• headache
• bruising
• abdominal pain
• anxiety

FYCOMPA may cause other serious side effects, including:

• mental (psychiatric) problems
• suicidal thoughts
• Dizziness, vertigo (sense of spinning), and problems walking normally
• Sleepiness and tiredness
• A serious allergic reaction

What special precautions should I follow?

• Antiepileptic drugs (AEDs), including FYCOMPA, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor for suicidal thoughts or behavior.
• FYCOMPA caused dose-related increases in events related to dizziness and disturbance in gait or coordination. Monitor for dizziness, gait disturbance, somnolence, and fatigue.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how FYCOMPA affects you. FYCOMPA may make you dizzy, sleepy, or tired.
• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking FYCOMPA until you talk to your healthcare provider. FYCOMPA taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse. FYCOMPA when taken with alcohol may also make your mood worse, increase anger, confusion, and depression.
• An increased risk of falls, in some cases leading to serious injuries including head injuries and bone fracture, occurred in patients being treated with FYCOMPA. Monitor for falls and injuries.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including FYCOMPA. Discontinue if no alternate etiology
• There is the potential of increased seizure frequency in patients with seizure disorders when antiepileptic drugs are withdrawn abruptly. In patients with epilepsy, there may be an increase in seizure frequency.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• somnolence
• stupor
• coma
• psychiatric or behavioral reactions
• altered mental status
• dizziness or gait disturbances

Treatment of overdosage:

• There is no available specific antidote to the overdose reactions of FYCOMPA.
• In the event of overdose, standard medical practice for the management of any overdose should be used.
• An adequate airway, oxygenation, and ventilation should be ensured; monitoring of cardiac rhythm and vital sign measurement is recommended.
• Due to its long half-life, the reactions caused by FYCOMPA could be prolonged.

Can this medicine be used in pregnancy?

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as FYCOMPA, during pregnancy.

Can this medicine be used in children?

• Safety and effectiveness of FYCOMPA for the treatment of partial-onset seizures have been established in pediatric patients 4 years of age and older.
• The safety and efficacy of FYCOMPA for the adjunctive therapy of primary generalized tonic-clonic seizures in pediatric patients 12 years of age and older was established.
• The safety and effectiveness of FYCOMPA for the treatment of partial-onset seizures in pediatric patients less than 4 years of age or for the treatment of primary generalized tonic-clonic seizures in pediatric patients less than 12 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: perampanel
• Inactive ingredients (tablets): lactose monohydrate, low substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, talc, and titanium dioxide. Tablets of different strengths also may contain yellow ferric oxide (10 mg and 2 mg), red ferric oxide (2 mg, 4 mg, 6 mg, 8 mg), black ferric oxide (8 mg), and FD&C blue # 2 (indigo carmine) aluminum lake (10 mg and 12 mg).
• Inactive ingredients (oral suspension): sorbitol, microcrystalline cellulose, carboxymethylcellulose sodium, poloxamer, simethicone, citric acid, sodium benzoate, and purified water.

Who manufactures and distributes this medicine?

• Marketed by Eisai Inc., Nutley, NJ

FYCOMPA® is a trademark owned by Eisai R&D Management

What should I know about storage and disposal of this medication?

• Store FYCOMPA tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Store FYCOMPA oral suspension below 86°F (30°C). Do not freeze.
• Replace the cap tightly after opening.
• Use FYCOMPA oral suspension within 90 days after the bottle is first opened.

• Dailymed label info on Perampanel
• FDA Perampanel

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