FYCOMPA- perampanel tablet FYCOMPA- perampanel suspension

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

PERAMPANEL (UNII: H821664NPK) (PERAMPANEL - UNII:H821664NPK)

Boleh didapati daripada:

Eisai Inc.

INN (Nama Antarabangsa):

PERAMPANEL

Komposisi:

PERAMPANEL 2 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

FYCOMPA is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. FYCOMPA is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.  None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as FYCOMPA, during pregnancy. Encourage women who are taking FYCOMPA during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. Risk Summary There are no adequate data on the developmental risk associated with use in pregnant women.  In animal studies, perampanel induced developmental toxicity in pregnant rat and rabbit at clinically relevant doses [ see Data ] . In the U.S. general population the estimated background risk

Ringkasan produk:

FYCOMPA Tablets FYCOMPA Oral Suspension Tablets: store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature] Oral Suspension: Do not store above 30°C (86°F). Do not freeze. Use within 90 days after the first opening of the bottle.

Status kebenaran:

New Drug Application

Risalah maklumat

FYCOMPA- PERAMPANEL SUSPENSION
Eisai Inc.
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MEDICATION GUIDE
FYCOMPA® (fī-COM-
puh) (perampanel) tablets, for oral
use, CIII
FYCOMPA® (fī-COM-puh)
(perampanel)
oral suspension, CIII
What is the most important information I should know about FYCOMPA?
1. 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.
2. Like other antiepileptic drugs, FYCOMPA may cause suicidal thoughts
or actions in a very small
number of people, about 1 in 500.
Call a 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.
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or
feelings.
•
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 a healthcare provider.
Stopping FYCOM

Ciri produk

FYCOMPA- PERAMPANEL TABLET
FYCOMPA- PERAMPANEL SUSPENSION
EISAI INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FYCOMPA
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FYCOMPA .
FYCOMPA (PERAMPANEL) TABLETS, FOR ORAL USE, CIII
FYCOMPA (PERAMPANEL) ORAL SUSPENSION, CIII
INITIAL U.S. APPROVAL: 2012
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SERIOUS OR LIFE-THREATENING PSYCHIATRIC AND BEHAVIORAL ADVERSE
REACTIONS INCLUDING
AGGRESSION, HOSTILITY, IRRITABILITY, ANGER, AND HOMICIDAL IDEATION AND
THREATS HAVE
BEEN REPORTED IN PATIENTS TAKING FYCOMPA (5.1)
MONITOR PATIENTS FOR THESE REACTIONS AS WELL AS FOR CHANGES IN MOOD,
BEHAVIOR, OR
PERSONALITY THAT ARE NOT TYPICAL FOR THE PATIENT, PARTICULARLY DURING
THE TITRATION
PERIOD AND AT HIGHER DOSES (5.1)
FYCOMPA SHOULD BE REDUCED IF THESE SYMPTOMS OCCUR AND SHOULD BE
DISCONTINUED
IMMEDIATELY IF SYMPTOMS ARE SEVERE OR ARE WORSENING (5.1)
INDICATIONS AND USAGE
FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is
indicated for:
Treatment of partial-onset seizures with or without secondarily
generalized seizures in patients with
epilepsy 4 years of age and older (1.1)
Adjunctive therapy in the treatment of primary generalized
tonic-clonic seizures in patients with
epilepsy 12 years of age and older (1.2)
DOSAGE AND ADMINISTRATION
Dosing in the absence of moderate or strong CYP3A4 inducers
Starting dose: 2 mg once daily orally at bedtime (2.1, 2.2)
May increase dose based on clinical response and tolerability by
increments of 2 mg once daily no
more frequently than at weekly intervals (2.1, 2.2)
Recommended maintenance dose in monotherapy or adjunctive therapy for
partial-onset seizures: 8
mg to 12 mg once daily at bedtime (2.1)
Recommended maintenance dose in adjunctive therapy for primary
generalized tonic-clonic seizures: 8
mg once daily at bedtime (2.2)
Measure oral suspension using provided adaptor and do