Fycompa

Generic Name: perampanel (per AM pa nel)
Brand Names: Fycompa

What is Fycompa?

Fycompa (perampanel) is an anticonvulsant used to treat seizures

Fycompa is a prescription medicine that is used with other medications to treat partial-onset seizures with or without secondarily generalized seizures in adults and children who are at least 12 years old.

Fycompa may also be used for purposes not listed in this medication guide.

Important information

Some people taking Fycompa have had serious psychotic effects, especially when starting the medication.

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.

Slideshow: Flashback: FDA Drug Approvals 2013

Before you take Fycompa, tell your doctor if you have liver or kidney disease, or a history of depression, mental illness, or addiction to drugs or alcohol.

Tell your doctor right away if you become pregnant while taking Fycompa for seizures. Do not start or stop taking Fycompa during pregnancy without your doctor's advice.

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

Never share Fycompa with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Before taking this medicine

You should not use Fycompa if you are allergic to perampanel, or if you have severe liver disease.

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

  • liver disease;

  • kidney disease;

  • a history of depression or mental illness; or

  • a history of drug or alcohol addiction.

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. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category C. Do not start or stop taking Fycompa 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 while taking Fycompa.

See also: Pregnancy and breastfeeding warnings (in more detail)

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Fycompa on the baby.

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

It is not known whether perampanel passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

Do not give this medication to anyone under 12 years old without medical advice.

How should I take Fycompa?

Fycompa is usually taken at bedtime. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may occasionally change your dose to make sure you get the best results.

Do not stop using any other seizure medications 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.

Keep track of the amount of medicine used from each new bottle. Fycompa may be a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Fycompa dosing information

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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

What happens if I overdose?

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

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of Fycompa.

Fycompa side effects

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

Stop using Fycompa and call your doctor at once if you have a side effect such as:

  • changes in mood, behavior, or personality;

  • anger, aggression, anxiety, trouble sleeping, feeling hostile or irritable;

  • talking more than usual;

  • unusual thoughts, paranoid behavior, panic attacks;

  • thoughts about suicide, or thoughts about hurting someone else;

  • trouble walking, loss of balance or coordination;

  • an accidental fall; or

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

Common Fycompa side effects may include:

  • mild dizziness;

  • drowsiness, tiredness;

  • nausea;

  • weight gain; or

  • headache, joint pain, back pain.

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.

See also: Side effects (in more detail)

What other drugs will affect Fycompa?

Taking Fycompa with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking Fycompa with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Fycompa, especially:

  • bosentan;

  • nafcillin;

  • pentobarbital;

  • St. John's wort;

  • rifabutin, rifapentine, rifampin;

  • HIV medications--efavirenz, nevirapine; or

  • other seizure medication--carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone.

This list is not complete. Other drugs may interact with Fycompa, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Fycompa.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Fycompa only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2013-01-24, 4:06:53 PM.

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