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| Please click here to read Important Safety Information about FYCOMPA®, including information about serious mental (psychiatric) problems. Talk to your doctor before taking FYCOMPA. |
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| Are you eligible to save on your seizure treatment? |
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| You may qualify to pay no more than $10 for your monthly FYCOMPA prescription (read eligibility criteria). The savings card is available from your doctor or find out more here: |
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| | • | FYCOMPA was studied in 4 clinical trials in people 12 years of age and older | | • | A total of 1119 people received FYCOMPA | | • | FYCOMPA plus 1 to 3 other seizure medicines was used to treat patients with: | | • | primary generalized tonic-clonic seizures | | • | partial-onset seizures with or without generalized seizures. | | | | | | |
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| FYCOMPA (perampanel) is a prescription medicine that is used with other medications to treat: | | | • | Partial-onset seizures with or without secondarily generalized seizures in people with epilepsy who are 12 years of age and older | | • | Primary generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older | | | |
| 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. | | |
| Before taking FYCOMPA, patients should tell their healthcare provider if they have or had mental problems, aggression or hostile behavior. | | |
| 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 | | • | St. John's wort | | | |
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| • | 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. | | |
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| | 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. | |  | | FYCOMPA® is a registered trademark of Eisai R&D Management Co., Ltd., licensed to Eisai Inc.
Manufactured and marketed by Eisai Inc., 100 Tice Blvd., Woodcliff Lake, NJ 07677
©2016 Eisai Inc. All rights reserved. FYCO-US0327 January 2016 | |
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