How to take FYCOMPA® liquid

YOU WILL NEED:

  • Liquid formulation bottle
  • Bottle adapter
  • Dosing syringe (1 dosing syringe is included in the FYCOMPA Oral
    Suspension box)

Step 1.

Take the FYCOMPA bottle, bottle adapter, and syringe out of the box.

Step 2.

Shake the bottle well—as you would shake a container of salad dressing—before each use.

Step 3.

Take the cap off the bottle. Put the bottle adapter into the bottle by pressing it down. After the bottle adapter is in place, you can't take it off. See A

Step 4.

Check the dose in milliliters (mL) of FYCOMPA liquid that your doctor prescribed. Find this number on the syringe. See B

Step 5.

Push the plunger of the syringe all the way down. While the bottle is upright, put the syringe into the bottle through the opening in the bottle adapter. See C

Step 6.

Hold the syringe in place, and turn the bottle and syringe upside down. Pull the plunger on the syringe to reach the dose your doctor prescribed (the amount of FYCOMPA medicine in Step 4). See D

If you see air bubbles in the syringe, fully push in the plunger so the medicine flows back into the bottle.

Then, pull the plunger on the syringe to reach the dose your doctor prescribed. Measure the mLs of FYCOMPA liquid from the white line at the end of the plunger, not the black line.

If your prescribed dose is more than 20 mL, go to Step 7. If your dose is 20 mL or less, skip Step 7 and go to Step 8.

Step 7.

If your dose is more than 20 mL, you can get the right amount of FYCOMPA by using the same syringe.

Draw the first 20 mL into the syringe and slowly squirt into the corner of your mouth (Steps 8 to 9).

Then, draw the remaining amount of medicine in the same syringe (Steps 4 to 6) and take FYCOMPA liquid (Steps 8 to 9).

Step 8.

Turn the bottle right-side up and take the syringe out of the bottle adapter.

Step 9.

Push down on the plunger to slowly squirt FYCOMPA directly into the corner of your mouth.

If your dose is more than 20 mL, slowly squirt FYCOMPA from the syringe into the corner of your mouth. Then repeat Steps 7 to 8 and slowly squirt FYCOMPA from the same syringe into the corner of your mouth. See E

Step 10.

Rinse the syringe with tap water after each use. To do this:

  • Fill a cup with water
  • Put the tip of the syringe in the water. Pull the plunger back to draw water from the cup into the syringe
  • Push down the plunger to release water into the sink. See F

Step 11.

Put the cap of the bottle and twist tightly. Leave the bottle adapter on. The cap will fit over the bottle adapter.



HOW TO STORE FYCOMPA LIQUID

  • Put the cap on the bottle. Twist it on tightly
  • Store FYCOMPA liquid below 86°F (30°C). Do not freeze
  • Replace the cap tightly after opening
  • Use FYCOMPA liquid within the first 90 days of opening the bottle
  • Safely throw out any FYCOMPA liquid that has not been used within 90 days of being opened

Please read the Medication Guide, including the information about serious mental (psychiatric) problems, at the end of the Prescribing Information. The Medication Guide does not take the place of talking with your healthcare provider about your condition or your treatment.

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Indication and Important Safety Information

What is FYCOMPA (perampanel)?

FYCOMPA is a prescription medicine used alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures in people with epilepsy aged 4 and older and with other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy aged 12 and older.

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.

Prescribing Information and Medication Guide for FYCOMPA.