NOW APPROVED
TO BE USED ALONE TO TREAT secondarily generalized CONVULSIVE seizures
TALK TO YOUR DOCTOR TO LEARN MORE

What is FYCOMPA® (perampanel)?

FYCOMPA is a prescription medicine used in people with epilepsy aged 12 and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures

Important Safety Information

FYCOMPA may cause mental (psychiatric) problems, including: new or worse aggressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability; being suspicious or distrustful (believing things that are not true); seeing objects or hearing things that are not there; confusion; difficulty with memory; other unusual or extreme changes in behavior or mood. Tell your healthcare provider right away if you have any new or worsening mental problems while taking FYCOMPA.

Like other antiepileptic drugs, FYCOMPA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; new or worse depression; feeling agitated or restless; trouble sleeping (insomnia); acting aggressive; being angry, or violent; an extreme increase in activity and talking (mania); attempt to commit suicide; new or worse anxiety; panic attacks; new or worse irritability; acting on dangerous impulses; other unusual changes in behavior or mood. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Pay attention to any changes especially sudden changes in mood, behaviors, thoughts, or feelings and keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop FYCOMPA without first talking with your healthcare provider. Stopping suddenly can cause serious problems and can cause you to have seizures more often.

Before taking FYCOMPA, tell your healthcare provider about all of your medical conditions, including if you: have or have had depression, mood problems, aggressive or hostile behavior (for example, homicidal behavior), suicidal thoughts or behavior, or other psychiatric problems; have liver or kidney problems; drink alcohol; have abused prescription medicines, street drugs, or alcohol in the past; are pregnant or plan to become pregnant. It is not known if FYCOMPA will harm your unborn baby. If you become pregnant while taking FYCOMPA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (1-888-233-2334); are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you take FYCOMPA and to decide if you will take FYCOMPA or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking FYCOMPA with certain other medicines can cause side effects or reduce either drug’s benefit. These medicines include: birth control, carbamazepine, phenytoin, oxcarbazepine, rifampin, and St. John’s Wort.

What should I avoid while taking FYCOMPA?
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 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.

FYCOMPA may cause other serious side effects, including: Dizziness, vertigo (sense of spinning), and problems walking normally. You may have problems walking normally if you are unsteady because you feel dizzy. These symptoms can increase when your dose of FYCOMPA is increased. Your risk of feeling dizzy and having problems walking normally may be higher if you are elderly; Sleepiness and tiredness; Increased risk of falls. Taking FYCOMPA can increase your chance of falling. These falls can cause serious injuries. Your risk of falling may be higher if you are elderly; A serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death. Call your healthcare provider right away if you have: a skin rash, hives; fever or swollen glands that do not go away; swelling of your face; shortness of breath; swelling of the legs; yellowing of the skin or whites of the eyes; or dark urine

The most common side effects of FYCOMPA 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 is a controlled substance (CIII) because it can be abused or lead to drug dependence. Keep FYCOMPA in a safe place to protect it from theft and never give it to anyone else because it may harm them. Selling or giving away FYCOMPA is against the law.

Taking FYCOMPA®

FYCOMPA: One dose, every night, at bedtime

  • FYCOMPA comes in tablet or liquid form
  • FYCOMPA tablets should be swallowed whole with water
  • Your FYCOMPA dose may start at 2 mg (4 mL liquid) or 4 mg (8 mL liquid) depending on the other seizure medicines you are taking
  • Your doctor may slowly raise your dose by 2 mg (4 mL) at a time. This is so you get the dose that works for you
  • Do not change your dose without first talking to your doctor
  • If you take more FYCOMPA than you are supposed to, call your local Poison Control Center or go to the nearest hospital emergency room right away
  • Please see Medication Guide for more detailed instructions on dosing
Fycompa dose conversion

Liquid is available as 0.5 mg/mL.

FYCOMPA comes in
different doses


FYCOMPA Seizure Medication Liquid and Tablet Doses

Dose visuals are not actual size or amount.


FYCOMPA Liquid Bottle Adapter Syringes

How to take FYCOMPA liquid

Step 1. Remove the FYCOMPA liquid bottle, adapter, and 2 syringes from the box.

Step 2. Shake the bottle well before each use.

Step 3. Uncap the bottle. Insert the adapter into the bottle. It will stay there until the bottle is empty.

FYCOMPA Liquid Bottle Adapter

Step 4. Find your dose (in milliliters [mL]) on the syringe.

FYCOMPA Liquid Dose Diagram

Step 5. Put the syringe in the upright bottle. Push the plunger all the way down.

FYCOMPA Syringe In Bottle

Step 6. With the syringe in place, turn the bottle upside down. Pull the plunger to the number of mL needed (the amount of liquid medicine in Step 4). If you see air bubbles in the oral syringe, fully push in the plunger so that the liquid medicine flows back into the bottle. Then, withdraw your prescribed dose of liquid medicine. Measure from the white layer at the end of the plunger, not the black layer.

FYCOMPA Syringe in Upside Down Bottle

Step 7. If the dose is more than 20 mL, you can use 2 syringes. Or you can use 1 syringe twice by repeating the steps above.

Step 8. Remove the syringe from the adapter.

Step 9. Slowly squirt FYCOMPA directly into the corner of your mouth.

Liquid FYCOMPA Oral Administration Diagram

Step 10. Rinse the syringe (or syringes) with tap water after each use.

Cleaning FYCOMPA Syringe After Dosing

Step 11. Cap the bottle tightly. The cap will fit over the adapter. Use within 90 days of first opening bottle.

Store at room temperature. Do not store above 86°F. Do not freeze.


Can FYCOMPA® cause serious mental (psychiatric) problems?

FYCOMPA may cause:

  • New or worse aggressive behavior
  • Homicidal thoughts or threats
  • Hostility
  • Anger
  • Anxiety
  • Irritability
  • Being suspicious or distrustful (believing things that are not true)
  • Other unusual or extreme changes in behavior or mood
 

Patients, their caregivers, and families should monitor for these changes and call their healthcare provider right away if they have any new or worsening mental problems while taking FYCOMPA. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. Patients taking FYCOMPA should avoid the use of alcohol.

What are the most common side effects seen when taking FYCOMPA®?

The most common side effects seen in patients receiving FYCOMPA were dizziness, sleepiness, headache, tiredness, irritability, falls, nausea, problems with muscle coordination, problems walking normally, vertigo, and weight gain. Tell your healthcare provider about any side effect that bothers you or does not go away.

 


NOW APPROVED
to be used alone to treat secondarily generalized convulsive seizures

Indication and Important Safety Information

What is FYCOMPA (perampanel)?

FYCOMPA® is a prescription medicine used in people with epilepsy aged 12 and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures

Important Safety Information

FYCOMPA may cause mental (psychiatric) problems, including: new or worse aggressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability; being suspicious or distrustful (believing things that are not true); seeing objects or hearing things that are not there; confusion; difficulty with memory; other unusual or extreme changes in behavior or mood. Tell your healthcare provider right away if you have any new or worsening mental problems while taking FYCOMPA.

Like other antiepileptic drugs, FYCOMPA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; new or worse depression; feeling agitated or restless; trouble sleeping (insomnia); acting aggressive; being angry, or violent; an extreme increase in activity and talking (mania); attempt to commit suicide; new or worse anxiety; panic attacks; new or worse irritability; acting on dangerous impulses; other unusual changes in behavior or mood. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Pay attention to any changes especially sudden changes in mood, behaviors, thoughts, or feelings and keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop FYCOMPA without first talking with your healthcare provider. Stopping suddenly can cause serious problems and can cause you to have seizures more often.

Before taking FYCOMPA, tell your healthcare provider about all of your medical conditions, including if you: have or have had depression, mood problems, aggressive or hostile behavior (for example, homicidal behavior), suicidal thoughts or behavior, or other psychiatric problems; have liver or kidney problems; drink alcohol; have abused prescription medicines, street drugs, or alcohol in the past; are pregnant or plan to become pregnant. It is not known if FYCOMPA will harm your unborn baby. If you become pregnant while taking FYCOMPA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (1-888-233-2334); are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you take FYCOMPA and to decide if you will take FYCOMPA or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking FYCOMPA with certain other medicines can cause side effects or reduce either drug’s benefit. These medicines include: birth control, carbamazepine, phenytoin, oxcarbazepine, rifampin, and St. John’s Wort.

What should I avoid while taking FYCOMPA?
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 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.

FYCOMPA may cause other serious side effects, including: Dizziness, vertigo (sense of spinning), and problems walking normally. You may have problems walking normally if you are unsteady because you feel dizzy. These symptoms can increase when your dose of FYCOMPA is increased. Your risk of feeling dizzy and having problems walking normally may be higher if you are elderly; Sleepiness and tiredness; Increased risk of falls. Taking FYCOMPA can increase your chance of falling. These falls can cause serious injuries. Your risk of falling may be higher if you are elderly; A serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death. Call your healthcare provider right away if you have: a skin rash, hives; fever or swollen glands that do not go away; swelling of your face; shortness of breath; swelling of the legs; yellowing of the skin or whites of the eyes; or dark urine

The most common side effects of FYCOMPA 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 is a controlled substance (CIII) because it can be abused or lead to drug dependence. Keep FYCOMPA in a safe place to protect it from theft and never give it to anyone else because it may harm them. Selling or giving away FYCOMPA is against the law.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.