e and Administration (2.7)].
Serious Psychiatric and Behavioral Reactions
Counsel patients, families, and caregivers of patients of the need to monitor for the emergence of anger, aggression, hostility, hallucinations, delusions, confusion, unusual changes in mood, personality, or behavior, and other behavioral symptoms. Advise them to report any such symptoms immediately to their healthcare providers [see Warnings and Precautions (5.1)].
Suicidal Thinking and Behavior
Counsel patients, their caregivers, and families that AEDs, including FYCOMPA, may increase the risk of suicidal thinking and behavior and advise them of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients, caregivers, and families to report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.2)].
Neurologic Effects: Dizziness, Gait Disturbance, Somnolence, and Fatigue
Counsel patients that FYCOMPA may cause dizziness, gait disturbance, somnolence, and fatigue. Advise patients taking FYCOMPA not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with FYCOMPA [see Warnings and Precautions (5.3)].
Falls
Counsel patients that FYCOMPA may cause falls and injuries [see Warnings and Precautions (5.4)].
Withdrawal of Antiepileptic Drugs
Counsel patients that abrupt discontinuation of FYCOMPA may increase seizure frequency [see Warnings and Precautions (5.5)].
Contraceptives
Counsel females of reproductive potential that FYCOMPA may decrease efficacy of contraceptives containing levonorgestrel, and advise them to use an additional non-hormonal form of contraception while using FYCOMPA and for a month after discontinuation [see Drug Interactions (7.1), Use in Specific Populations (8.3)].
Alcohol and Other CNS Depressants
Counsel patients that FYCOMPA may enhance the impairment effects of alcohol. These effects may also be seen if FYCOMPA is taken with other CNS depressants [see Drug Interactions (7.3)].
Missed Doses
Counsel patients that if they miss a dose, they should resume dosing the following day at their prescribed daily dose. Instruct patients to contact their physician if more than one day of dosing is missed.
Controlled Substance
Counsel patients that FYCOMPA is a controlled substance that can be misused and abused [see Drug Abuse and Dependence (9.1)].
Pregnancy Registry
Advise women who are exposed to FYCOMPA during pregnancy that there is a pregnancy exposure registry that monitors pregnancy outcomes. Encourage these patients to enroll in the NAAED Pregnancy Registry [see Use in Specific Populations (8.1)].
FYCOMPA® is a registered trademark owned by Eisai R&D Management Co., Ltd.
Marketed by Eisai Inc., Woodcliff Lake, NJ 07677
©2016 Eisai Inc.
Close
MEDICATION GUIDE
MEDICATION GUIDE
FYCOMPA® (fī-COM-puh)
(perampanel)
Tablets FYCOMPA® (fī-COM-puh)
(perampanel) Oral Suspension
What is the most important information I should know about FYCOMPA?
1. FYCOMPA may cause mental (psychiatric) problems, including:
new or worse ag |
