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.

 


Indication and Important Safety Information

Indication

FYCOMPA (perampanel) is a prescription medicine used with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older.

Important Safety Information

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), and other unusual or extreme changes in behavior or mood. Before taking FYCOMPA, patients should tell their healthcare provider if they have or had mental problems, aggression or hostile behavior.

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.

Antiepileptic drugs, including FYCOMPA, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients should call their healthcare providers right away if they have any of the following symptoms, especially if they are new, worse, or worrisome: thoughts about suicide or dying, thoughts of self-harm, attempt to commit suicide, new or worse depression, new or worse anxiety, feeling agitated or restless, panic attacks, trouble sleeping (insomnia), new or worse irritability, acting aggressive, being angry or violent, acting on dangerous impulses, an extreme increase in activity and talking (mania), and other unusual changes in behavior or mood.

Patients may have problems walking normally if they are unsteady because they feel dizzy. These symptoms may increase when their dose of FYCOMPA is increased. A patient’s risk of feeling dizzy and having problems walking normally may be higher if they are elderly. FYCOMPA may make patients feel sleepy or tired. Patients should not drive, operate heavy machinery, or do other dangerous activities until they know how FYCOMPA affects them. A patient’s risk of feeling sleepy and tired may be higher if they are elderly.

Taking FYCOMPA may increase a patient's chance of falling. These falls can cause serious injuries. A patient's risk of falling may be higher if they are elderly.

Patients must not stop FYCOMPA without first talking to their healthcare provider. Stopping FYCOMPA suddenly can cause serious problems and can cause patients to have seizures more often.

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.

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 other medicines include: birth control, carbamazepine, phenytoin, oxcarbazepine, rifampin, and St. John’s wort.

Before taking FYCOMPA, patients should tell their healthcare provider if they drink alcohol. Patients should not drink alcohol or take other medicines that make them sleepy or dizzy while taking FYCOMPA until they talk to their healthcare provider. FYCOMPA taken with alcohol or medicines that cause sleepiness or dizziness may make their sleepiness or dizziness worse.

Before taking FYCOMPA, patients should tell their healthcare provider if they are pregnant or plan to become pregnant while taking FYCOMPA. It is not known if FYCOMPA will harm your unborn baby. If a patient becomes pregnant while taking FYCOMPA, they should talk to their healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (1-888-233-2334).

Before taking FYCOMPA, patients should tell their healthcare provider if they are breastfeeding or plan to breastfeed. Patients should talk to their healthcare provider about the best way to feed their baby if they take FYCOMPA. Patients should not take FYCOMPA if they breastfeed.

Before taking FYCOMPA, patients should tell their healthcare provider if they have liver or kidney problems. They should not take FYCOMPA if they have severe kidney or liver problems.

FYCOMPA is a controlled substance (CIII) because it can be abused or lead to drug dependence. Before taking FYCOMPA, patients should tell their healthcare provider if they have abused prescription medicines, street drugs, or alcohol in the past. Patients should keep their FYCOMPA in a safe place to protect it from theft and should never give it to anyone else because it may harm them. Selling or giving away FYCOMPA is against the law.