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FYCOMPA- perampanel tabletFYCOMPA- perampanel suspension


  1. Patient Information
  2. Neurologic Effects:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication GuideandInstructions for Use).

Administration of Oral Suspension

Advise patients who are prescribed the oral suspension to shake the bottle well before every administration and to use the adaptor and oral dosing syringe provided. Advise patients that a household teaspoon or tablespoon is not an adequate measuring device. Instruct patients to discard any unused FYCOMPA oral suspension remaining 90 days after first opening the bottle[seeDosage 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[seeWarnings 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[seeWarnings 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[seeWarnings and Precautions (5.3)].

Falls

Counsel patients that FYCOMPA may cause falls and injuries[seeWarnings and Precautions (5.4)].

DRESS/Multi-organ Hypersensitivity

Instruct patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately[seeWarnings and Precautions (5.5)].

Withdrawal of Antiepileptic Drugs

Counsel patients that abrupt discontinuation of FYCOMPA may increase seizure frequency[seeWarnings and Precautions (5.6)].

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[seeDrug 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[seeDrug 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[seeDrug 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[seeUse in Specific Populations (8.1)].

FYCOMPAis a registered trademark owned by Eisai R&D Management Co., Ltd.

Marketed by Eisai Inc., Woodcliff Lake, NJ 07677

2019 Eisai Inc.



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