Fycompa is an anticonvulsant used to treat seizures in adults and children.

Fycompa is used to treat partial onset seizures that may or may not develop into general seizures in people with epilepsy who are at least 4 years old.

Fycompa is also used with other medications to treat primary generalized tonic-clonic (PGTC) seizures in patients 12 years of age and older.

Some people taking Fycompa have had serious psychotic effects, especially when starting this medicine or changing doses. Stay alert to changes in your mood or symptoms.

Call your doctor right away if you have any changes in mood or behavior changes, personality changes, thoughts about suicide, or thoughts about hurting others. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Before taking this medicine

You should not use Fycompa if you are allergic to perampanel.

To make sure Fycompa is safe for you, tell your doctor if you have:

• depression, a mood disorder, or other mental health problems;

• thoughts of hurting yourself or others;

• liver or kidney disease;

• drug addiction; or

• if you drink alcohol.

Some people taking Fycompa have had serious psychotic effects such as anger, aggression, feeling hostile or irritable, and thoughts about hurting others. These effects may be more likely to occur when you first start taking Fycompa, or whenever your dose is changed. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

Fycompa can make some birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of perampanel on the baby.

It may not be safe to breastfeed while using Fycompa. Ask your doctor about any risk.

Fycompa is usually taken at bedtime. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Perampanel may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not stop using Fycompa suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat. Do not freeze.

Throw away any leftover liquid medicine 90 days after you first opened the bottle.

Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Usual Adult Dose of Fycompa for Seizures:

In the absence of enzyme inducing AEDs:
Initial dose: 2 mg orally once daily at bedtime. Dosage may be increased by 2 mg orally daily in increments no more frequently than every week.
Maintenance dose: 4 to 12 mg orally once daily at bedtime
Maximum dose: 12 mg orally once daily at bedtime

In the presence of enzyme inducing AEDs (including phenytoin, carbamazepine, and oxcarbazepine):
Initial dose: 4 mg orally once daily at bedtime. Patients should be monitored closely for response. Studies revealed a substantially reduced effect on seizure rates in these patients. When these enzyme-inducing AEDs are introduced or withdrawn from a treatment regimen, the patient should be monitored for clinical response and tolerability. Dose adjustment of perampanel may be necessary.
Maximum dose: 12 mg orally once daily at bedtime

Approved indication: Adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.

Usual Pediatric Dose of Fycompa for Seizures:

Greater than or equal to 12 years of age:

In the absence of enzyme inducing AEDs: Initial dose: 2 mg orally once daily at bedtime. Dosage may be increased by 2 mg orally daily in increments no more frequently than every week. Maintenance dose: 4 to 12 mg orally once daily at bedtime Maximum dose: 12 mg orally once daily at bedtime

In the presence of enzyme inducing AEDs (including phenytoin, carbamazepine, and oxcarbazepine): Initial dose: 4 mg orally once daily at bedtime. Patients should be monitored closely for response. Studies revealed a substantially reduced effect on seizure rates in these patients. When these enzyme-inducing AEDs are introduced or withdrawn from a treatment regimen, the patient should be monitored for clinical response and tolerability. Dose adjustment of perampanel may be necessary.
Maximum dose: 12 mg orally once daily at bedtime

Approved indication: Adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.

You should not use Fycompa if you are allergic to perampanel.

To make sure Fycompa is safe for you, tell your doctor if you have:

• depression, a mood disorder, or other mental health problems;

• thoughts of hurting yourself or others;

• liver or kidney disease;

• drug addiction; or

• if you drink alcohol.

Some people taking Fycompa have had serious psychotic effects such as anger, aggression, feeling hostile or irritable, and thoughts about hurting others. These effects may be more likely to occur when you first start taking Fycompa, or whenever your dose is changed. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

Fycompa can make some birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of perampanel on the baby.

It may not be safe to breastfeed while using Fycompa. Ask your doctor about any risk.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Call your doctor for instructions if you miss your Fycompa dose for more than one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction to Fycompa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, fear, panic attacks, trouble sleeping, or if you feel irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself or someone else.

Call your doctor at once if you have:

• severe dizziness, spinning sensation, feeling like you might pass out;

• trouble walking, loss of balance or coordination;

• feeling very weak or tired;

• an accidental fall; or

• memory problems, confusion, hallucinations.

Accidental falls may occur more often in elderly patients who take Fycompa. Use caution to avoid falling or accidental injury while taking this medicine.

Common Fycompa side effects may include:

• headache, dizziness, drowsiness;

• feeling anxious, tired, or irritable;

• nausea, vomiting, stomach pain;

• bruising;

• weight gain; or

• loss of coordination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Fycompa with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• birth control pills;

• rifampin;

• St. John's wort;

• other seizure medicine - carbamazepine, oxcarbazepine, phenytoin.

This list is not complete. Other drugs may interact with perampanel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.