Tomorrows Convulsive seizure control is possible* - Fycompa
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w it h F Y C O M PA®
G e tt in g s ta rt e d
seize YOUR
ws m o r r o
tCono
vu ls iv e s e iz u re c o n
*
tr o l is p o s s ib le
*In clinical trials, some patients taking FYCOMPA experienced fewer seizures. Individual results may vary.
What is FYCOMPA (perampanel)?
FYCOMPA is a prescription medicine used:
•a
lone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures
in people with epilepsy aged 4 and older
•w
ith other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy aged 12 and older
Selected Safety Information
FYCOMPA may cause serious mental (psychiatric) problems. Tell your healthcare provider right away
if you have any new or worsening mental problems while taking FYCOMPA.
Please see Important Safety Information on pages 22 to 23
and enclosed Prescribing Information and Medication Guide.
YOUR TREATMENT WITH FYCOMPA®
STARTS HERE
Whether you’ve been recently diagnosed with epilepsy or have tried multiple treatment options before, you’re
looking for seizure control. You and your doctor have decided FYCOMPA might be able to help. This brochure
is here to provide education and support as you begin treatment with FYCOMPA. Read on to learn about
epilepsy, how FYCOMPA may help you, and what resources are available.
You’re here because you want to live life on your terms. You may even have hopes for seizure freedom. With the
right treatment and a healthy lifestyle, you can work toward the possibility of convulsive seizure control.
Selected Safety Information
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 • confusion
behavior), hostility, anger, anxiety, or irritability • difficulty with memory
• being suspicious or distrustful (believing things that are not true) • other unusual or extreme
• seeing objects or hearing things that are not there changes in behavior or mood
Tell your healthcare provider right away if you have any new or worsening mental problems while
2 taking FYCOMPA.
o n te n t s
o f C
Table
6
y 8
ut Epileps
L ea r n A b o
ilepsy ?
W h at Is Ep
h Epilepsy
L iv in g W it 14
Help 16
MPA® Ca n
How F YCO ferent Ty p
e s of S e iz u
re s 18
Treats D if
F YCOMPA 20
S e iz u re s
Y C O M PA Ca n Reduce
F 22
ily D osi n g
t O nce -Da
Conven ien
PA L iqu id
k e F YC O M
How to Ta
rm ation
Sa fety In fo
Imp orta nt 26
t You Need
28
pp o r
G e t t h e Su g s Ca rd P ro
g ra m 30
a nt Sav in
MPA® In st
T h e F YC O Supp ort
it h O th e rs a nd G et
Con ne ct W
Epilepsy
m it ment to
E is a i’s Com
Please see Important Safety Information on pages 22 to 23
and enclosed Prescribing Information and Medication Guide.
3
U T
Y
B O
S
N A
P
LEA R
EPIL E
What is epilepsy?
Epilepsy is a condition of the brain that causes seizures. The brain is a complex system of nerves and cells
(and a lot of other parts too). These all work together to communicate signals to different parts of the body,
telling them what to do. Everything from eating, talking, and walking is controlled by and depends on these
signals working right.
In people with epilepsy, these signals become overloaded and confused. Too many signals, or the wrong
type of signals being sent at once, are what cause a seizure.
WHAT HAPPENS DURING A SEIZURE?
How you MOVE, ACT, or FEEL can change during a seizure.
During a seizure you MIGHT GET CONFUSED and MAY NOT BE AWARE OF WHAT’S GOING ON around you.
6You are not alone
Millions of people in the United States and worldwide have epilepsy.
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E P IL E P S Y IN T H
7LIVING WITH epilepsy
As you may already know, living with epilepsy means it’s important to consider your overall health in
addition to managing your seizures. You should always take your medicine as prescribed by your doctor.
It’s also important to take care of your body and practice self-care. This is critical for your physical and
emotional health.
Remember to take your medicine as prescribed by your doctor.
MISSING EVEN 1 DOSE CAN HAVE A NEGATIVE IMPACT ON YOUR HEALTH.
8Some tips to stay healthy
Stress can come on quickly
Think about what you’re and have damaging effects
putting into your body. on your brain and body.
Drinking alcohol—and Are you maintaining Think of ways to unwind
Everyone needs skipping doses of your a well-balanced diet? and focus on what’s
time to wind down medication to do so— Consider the many benefits important to you.
and relax. Taking it can be dangerous to of eating healthy.
easy is important. your health.
FINDING THE RIGHT TREATMENT OPTION FOR YOUR EPILEPSY IS IMPORTANT.
But it’s just 1 piece of the puzzle. Staying committed to your health,
as mentioned above, can also help.
9LIVING WITH EPILEPSY
Unfortunately, seizures can happen even if you are
taking medicine. You may have heard these referred to as
breakthrough seizures. Sometimes they occur because your
medicine is no longer working for you. Often times, these
seizures happen when a dose is missed because the medicine
does not stay in the body for a long time.
But life is hectic and we’re only human, so missed doses can
happen. It’s important to plan ahead as best you can and take
your medicine as prescribed to try to avoid experiencing a
seizure while on treatment.
1011
HOW
O M P A
FYC CAN HELP
®
Please see Important Safety Information on pages 22 to 23
and enclosed Prescribing Information and Medication Guide.FYCOMPA® treats different TYPES
OF SEIZURES
PARTIAL •U
sually last less •C
hanges in smell, taste,
than 2 minutes and hearing
• Experiences can •S
trange sensations in the
PARTIAL-ONSET Happen in vary depending on body can occur or impact
SEIZURES one part of where the seizure how people think or
the brain experience events
(ALSO KNOWN AS “FOCAL”) occurs in the brain
•S
tiffening or jerking •S
ometimes memory
movements is lost
Selected Safety Information
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 new or worsening symptoms.
14FYCOMPA® is a prescription medicine used:
• to treat partial-onset seizures with or without secondarily generalized seizures in people with epilepsy
who are 4 years of age and older
• with other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy who
are 12 years of age and older
CONVULSIVE • Usually last 1 to 3 minutes
Start on one side
SECONDARILY of the brain and
• Happen without warning
GENERALIZED SEIZURES spread to the other • M
ovements can be strong
or forceful
• L
oss of consciousness, falling
to the floor
PRIMARY GENERALIZED Can start on both •B
reathing can be temporarily
TONIC-CLONIC SEIZURES sides of the brain impaired
at the same time
(ALSO KNOWN AS “GRAND MAL”) •N
o memory of the event
happening
Please see Important Safety Information on pages 22 to 23
and enclosed Prescribing Information and Medication Guide.
15It’s Time To Seize Your Tomorrows
FYCOMPA® may help control your seizures
The studies used to gain FDA approval of FYCOMPA studied how effective
FYCOMPA was at reducing certain types of seizures.
arch :
Ba se d on th is re se
ith FYCOMPA* experienc
ed:
s ar e ex pe ct ed in patients with
ar s of ag e and ol de r tr ea te d w Similar result w hen FYCOMPA is us
ed
Some pa tients 12 ye se t se iz ur es
in th e n u m b e r of seizures they partial-on
ch ild re n 4 years of age or
older
A decrease se iz ures happened alon e or in
h ow of te n
had and
sa m e re su lt s w it h FY C O M PA
N o t a ll p a ti e n ts h a d th e
drugs.
tiepileptic
plus 1 to 3 an
*FYCOMPA
Selected Safety Information
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.
16Is seizure freedom possible for me?
Clinical studies provide information about the safety and effectiveness of a medicine.
The main purpose of the FYCOMPA® studies was measuring the number of seizures and how often
the seizures happened. Sometimes researchers look for results that were not part of the main
purpose of the study. In the FYCOMPA studies, researchers also looked for patients who achieved
seizure freedom (meaning patients had no seizures) over the course of 13 weeks. These results were
measured either during the study or after the study ended.
While measuring seizure freedom was not the main purpose of the studies, results from these separate
reviews of the data showed that some patients achieved seizure freedom while taking FYCOMPA.
Because measuring seizure freedom was not the main purpose of the FYCOMPA studies, the data are
not considered to be significant. This means the data are not meaningful enough to be able to draw
conclusions about these results.
While some patients experienced seizure freedom with FYCOMPA, everyone reacts differently
to medicine and may experience different results.
TALK TO YOUR DOCTOR TO LEARN MORE ABOUT FYCOMPA
Please see Important Safety Information on pages 22 to 23
and enclosed Prescribing Information and Medication Guide.
17CONVENIENT ONCE-DAILY DOSING
Living with epilepsy already has its challenges. The simple administration of FYCOMPA® fits into your daily routine.
ONE DOSE ONCE DAILY AT BEDTIME
FYCOMPA comes in
small tablet or liquid form.
FYCOMPA HAS A LONG HALF-LIFE
Half-life describes how long a medicine stays in your body. Half-life is important in epilepsy treatment
because medicines with longer half-lives stay in your body at steadier levels for a longer time even in the event you
miss a dose. Talk to your doctor if you miss one or more of your doses or if you have questions about what
a long half-life means to you. Remember to always take your medication as prescribed by your doctor.
Selected Safety Information
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.
18FYCOMPA® is taken once daily, whenever you go to bed
Depending on what type of seizures you are experiencing, FYCOMPA
can be taken alone or with other medicines. Your doctor will first
START FYCOMPA start you on a low dose. Then, your doctor will slowly increase your
LIQUID OR TABLET dose to be sure you get the amount of FYCOMPA that’s right for you.
Your dose could be increased as slowly as every 2 to 4 weeks, but no
more than once a week, depending on how FYCOMPA works for you.
ou should take FYCOMPA every night at bedtime, whenever
Y
TAKE FYCOMPA that may be. Sometimes life can get hectic so your bedtime may
be different from night to night and that’s OK. It won’t change
AT BEDTIME
the way FYCOMPA works.
If you notice any reactions to FYCOMPA, it’s important to let your
MONITOR FOR doctor know right away. Your doctor may lower or discontinue your
ANY REACTIONS dose depending on how you react to FYCOMPA.
Please see Important Safety Information on pages 22 to 23
and enclosed Prescribing Information and Medication Guide.
19H O W T O TA K E
F YCOMP A ®
STEP 5
C
LIQUID Push the plunger of the syringe all the way
down. While the bottle is upright, put the
YO U W IL L NE ED : io n bo tt le syringe into the bottle through the opening
at
• Li qu id fo rm ul in the bottle adapter. See C
te r
• Bo tt le ad ap s)
ri ng e( D
• Do si ng sy STEP 6
STEP 1
Hold the syringe in place, and turn the bottle
and syringe upside down. Pull the plunger
Take the FYCOMPA bottle, bottle adapter,
on the syringe to reach the dose your doctor
and syringe(s) out of the box.
prescribed (the amount of FYCOMPA medicine
STEP 2 in Step 4). If you see air bubbles in the syringe, fully push in
the plunger so the medicine flows back into the bottle. Then,
Shake the bottle well—like you A pull the plunger on the syringe to reach the dose your doctor
would shake a container of salad prescribed. Measure the mLs of FYCOMPA liquid from the
dressing—before each use. white line at the end of the plunger, not the black line.
STEP 3 If the prescribed dose is more than 20 mL, go to Step 7. If
the dose is 20 mL or less, skip Step 7 and go to Step 8. See D
Take the cap off the bottle. Put the bottle
adapter into the bottle by pressing it down.
After the bottle adapter is in place,
B
STEP 7
you can’t take it off. See A the dose is more than 20 mL, you may use 2 syringes.
If
Or you may use 1 syringe twice by repeating the steps above.
STEP 4 If using 1 syringe, draw the first 20 mL into the syringe and
Check the dose in milliliters (mL) slowly squirt into the corner of the mouth (Steps 8 to 9).
of FYCOMPA liquid that your doctor Then, draw the remaining amount of medicine in the same
prescribed. Find this number on the syringe. See B syringe (Steps 4 to 6) and take FYCOMPA liquid (Steps 8 to 9).
20STEP 8
Turn the bottle right-side up and take the syringe H O W T O S T O RlEiquid
out of the bottle adapter.
FYCOMPA
STEP 9 Tw ist it
Push down on the plunger to slowly squirt FYCOMPA® on the bott le.
Put the cap
directly into the corner of the mouth and slowly squirt
on tightly
FYCOMPA from the syringe into the
E below 86°F
corner of the mouth. See E MPA liquid
Store F YCO
ot freeze
(30°C ). Do n
STEP 10 y after
Rinse the syringe(s) with tap water after each use. e cap tightl
Replace th
To do this:
opening
• Fill a cup with water
ithin the
• Put the tip of the syringe(s) in the water. PA liquid w
F Use F YCOM g the bott le
Pull the plunger back to draw water from s of openin
the cup into the syringe(s) first 90 day
• Push down the plunger to release water into liquid that
F YCOMPA
the sink. See F Do not use tt le for
b ee n in an open bo
h a s fely throw
90 days. Sa
STEP 11 m
o u
o
t
re
a
th
ny
a
F
n
Y COMPA liq
uid that ha
s of
s
90 day
Put the cap on the bottle and twist tightly. Leave the sed w ithin
bottle adapter on. The cap will fit over the bottle adapter. not been u
ed
being open
Please see Important Safety Information on pages 22 to 23
and enclosed Prescribing Information and Medication Guide.
21Important Safety Information
What is the most important • acting aggressive, being angry, Before taking FYCOMPA, tell your
information I should know or violent healthcare provider about all of
about FYCOMPA®? • an extreme increase in activity your medical conditions, including
1. F
YCOMPA may cause mental and talking (mania) if you:
(psychiatric) problems, including: • attempt to commit suicide • have or have had depression,
• new or worse aggressive behavior • new or worse anxiety mood problems, aggressive or
(including homicidal behavior), • panic attacks hostile behavior (for example,
hostility, anger, anxiety, or irritability • new or worse irritability homicidal behavior), suicidal
• being suspicious or distrustful • acting on dangerous impulses thoughts or behavior, or other
(believing things that are not true) • other unusual changes in behavior psychiatric problems
• seeing objects or hearing things or mood • have liver or kidney problems
that are not there Suicidal thoughts or actions can • drink alcohol
• confusion be caused by things other than • have abused prescription medicines,
• difficulty with memory medicines. If you have suicidal street drugs, or alcohol in the past
• other unusual or extreme changes thoughts or actions, your healthcare • are pregnant or plan to become
in behavior or mood provider may check for other causes. pregnant. It is not known if
Tell your healthcare provider right FYCOMPA will harm your unborn
How can I watch for early baby. If you become pregnant
away if you have any new or
symptoms of suicidal thoughts while taking FYCOMPA, talk to
worsening mental problems while
and actions? your healthcare provider about
taking FYCOMPA.
• Pay attention to any changes registering with the North American
2. L
ike other antiepileptic drugs, especially sudden changes in mood, Antiepileptic Drug Pregnancy
FYCOMPA may cause suicidal behaviors, thoughts, or feelings Registry (1-888-233-2334)
thoughts or actions in a very • Keep all follow-up visits with your • are breastfeeding or plan to
small number of people, about 1 in healthcare provider as scheduled breastfeed. Talk to your healthcare
500. Call your healthcare provider Call your healthcare provider provider about the best way to
right away if you have any of these between visits as needed, especially if feed your baby if you take FYCOMPA
symptoms, especially if they are you are worried about symptoms. and to decide if you will take
new, worse, or worry you: FYCOMPA or breastfeed. You should
• thoughts about suicide or dying Do not stop FYCOMPA without
first talking with your healthcare not do both.
• new or worse depression
• feeling agitated or restless provider. Stopping suddenly can
• trouble sleeping (insomnia) cause serious problems and can cause
you to have seizures more often.
22Tell your healthcare provider about •D izziness, vertigo (sense of The most common side effects of
all the medicines you take, including spinning), and problems walking FYCOMPA include:
prescription and over-the-counter normally. You may have problems • dizziness •p roblems walking
medicines, vitamins, and herbal walking normally if you are • sleepiness normally
supplements. Taking FYCOMPA® unsteady because you feel dizzy. • tiredness •p roblems with
with certain other medicines can These symptoms can increase when • irritability muscle coordination
cause side effects or reduce either the dose of FYCOMPA is increased. • falls • headache
drug’s benefit. These medicines Your risk of feeling dizzy and having •n ausea and • bruising
include: birth control, carbamazepine, problems walking normally may be vomiting • abdominal pain
phenytoin, oxcarbazepine, rifampin, higher if you are elderly. • weight gain • anxiety
and St. John’s Wort.
• Sleepiness and tiredness •v ertigo (sense
What should I avoid while • I ncreased risk of falls. Taking of spinning)
taking FYCOMPA? FYCOMPA can increase your FYCOMPA is a controlled substance
Do not drive, operate heavy chance of falling. These falls can (CIII) because it can be abused
machinery, or do other dangerous cause serious injuries. Your risk or lead to drug dependence. Keep
activities until you know how of falling may be higher if you FYCOMPA in a safe place to protect
FYCOMPA affects you. FYCOMPA are elderly. it from theft and never give it
may make you dizzy, sleepy, or tired. •A serious allergic reaction that
Do not drink alcohol or take other to anyone else because it may
may affect your skin or other harm them. Selling or giving away
medicines that make you sleepy parts of your body such as your
or dizzy until you talk to your FYCOMPA is against the law.
liver, kidneys, heart, or blood cells.
healthcare provider. FYCOMPA This allergic reaction can be life- You are encouraged to report
taken with alcohol or medicines that threatening and can cause death. negative side effects of
cause sleepiness or dizziness may Call your healthcare provider right prescription drugs to the FDA.
make your sleepiness or dizziness away if you have: Visit www.fda.gov/medwatch
worse. FYCOMPA when taken with or call 1-800-FDA-1088.
–a skin rash, hives
alcohol may also make your mood
–fever or swollen glands that do
worse, increase anger, confusion,
not go away
and depression.
–swelling of your face
What are the possible side effects –shortness of breath, swelling of
of FYCOMPA? the legs, yellowing of the skin or
FYCOMPA may cause other serious whites of the eyes, or dark urine
side effects, including:
Please see enclosed Prescribing Information and Medication Guide.
23Get the
p o r t
sup you need
Please see Important Safety Information on pages 22 to 23
and enclosed Prescribing Information and Medication Guide.A ® I N S T A NT
H E F Y C O MP G R AM
T AR D P R O
V I N G S C A®
SA A S $ 10 PER MON
T H * F O R F Y C O M P
PAY A S L IT T L E
Once you’ve been prescribed FYCOMPA, you can receive your
savings card through your doctor or by visiting FYCOMPA.com
and clicking the “Register or Activate now” link. You can also activate
the card by calling 1-855-347-2448.
• Bring your card to the pharmacy
•S
how your savings card to the pharmacist each time
you fill your prescription
The back of the card has details for the savings program. This will help ensure that the offer applies to
you. Eligible commercially insured patients may pay as little as $10 per month with a maximum savings
of $1,300 per year.
Eligible cash patients can receive up to $60 per prescription for a maximum savings of $720 per year.
Ask your doctor or pharmacist if you are not sure whether the offer applies to you.
*Restrictions apply. Not available to patients enrolled in federal or state healthcare programs, including Medicare, Medicaid, Medigap,
VA, DoD, or TRICARE. See https://www.fycompa.com/savings-card for complete terms and conditions.
26FYCOMPA® Patient Assistance Program
In addition to the FYCOMPA® Instant Savings Card, this program provides information
that may help you pay for your medicine.
If you qualify, you may be able to get FYCOMPA® at no cost and receive other resources.
Call 1-855-347-2448 or visit EisaiReimbursement.com to learn more.
Eisai is COMMITTED TO SUPPORTING PATIENTS by
providing information that may help you get access to the treatment you need
Please see Important Safety Information on pages 22 to 23
and enclosed Prescribing Information and Medication Guide.
27Connect with others and
get support
Living with epilepsy can be stressful, but you don’t have to face it alone. Keep an open channel of communication
with your doctor in case you have any questions or concerns about treatment with FYCOMPA®.
MORE THAN 300,000 PEOPLE WORLDWIDE
HAVE BEEN PRESCRIBED FYCOMPA * †
It can also help to talk to other people who have epilepsy. You can learn a lot from
them and they can learn a lot from you, too. You can star t by hearing from patients
like you who wanted to share their stor y at F YCOMPA.com.
*Worldwide figure from 2012 through December 2019. Over 40,000 patients prescribed FYCOMPA in the United States.
†
Across different indications.
28Other helpful resources:
Advancing Epilepsy Care Centers for Disease Control Citizens United for Research
advancingepilepsycare.com and Prevention (CDC) in Epilepsy (CURE)
CDC.gov/epilepsy CUREepilepsy.org
National Association of The Epilepsy Foundation North American Antiepileptic
Epilepsy Centers (NAEC) Epilepsy.com Drug Pregnancy Registry
NAEC-epilepsy.org AEDpregnancyregistry.org
IF Y O U A R E C AEROINNGE
FO R S O M
Visit FYCOMPA.com for information
specifically for caregivers.
WITH EPILEPSY
Please see Important Safety Information on pages 22 to 23
and enclosed Prescribing Information and Medication Guide.
29Eisai’s commitment
to epilepsy
Eisai is a pharmaceutical company committed to putting patients and families first,
and is driven by a deeply rooted history of helping patients and caregivers. Eisai has
studied multiple medicines for the treatment of epilepsy.
Community outreach
Eisai is actively involved in the community and supporting foundations that
help spread awareness about epilepsy. Find out more about Eisai’s commitment
to patients with epilepsy by visiting us.eisai.com.
3031
U R
®:
FYCOMPA
seize YO le a rn in g m o re ? Visit F YC OMPA .c om
ws In te re s te d in
tomorro
Selected Safety Information
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.
Please see Important Safety Information on pages 22 to 23
and enclosed Prescribing Information and Medication Guide.
FYCOMPA® is a registered trademark of Eisai R&D Management Co., Ltd., licensed to Eisai Inc.
©2021 Eisai Inc. FYCO-US4233 August 2021HIGHLIGHTS OF PRESCRIBING INFORMATION • Severe Renal Impairment or on Hemodialysis: Not recommended (2.5)
These highlights do not include all the information needed to use FYCOMPA® • Elderly: Increase dose no more frequently than every 2 weeks (2.6)
safely and effectively. See full prescribing information for FYCOMPA ® .
----------------------DOSAGE FORMS AND STRENGTHS------------------
FYCOMPA® (perampanel) tablets, for oral use, CIII
• Tablets: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg (3)
FYCOMPA® (perampanel) oral suspension, CIII
Initial U.S. Approval: 2012 • Oral Suspension: 0.5 mg/mL (3)
----------------------------------CONTRAINDICATIONS-----------------------
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS None (4)
See full prescribing information for complete boxed warning.
-----------------------WARNINGS AND PRECAUTIONS---------------------
• Serious or life-threatening psychiatric and behavioral adverse reactions • Suicidal Behavior and Ideation: Monitor for suicidal thoughts or
including aggression, hostility, irritability, anger, and homicidal ideation behavior (5.2)
and threats have been reported in patients taking FYCOMPA (5.1) • Neurologic Effects: Monitor for dizziness, gait disturbance, somnolence,
• Monitor patients for these reactions as well as for changes in mood, and fatigue (5.3)
behavior, or personality that are not typical for the patient, particularly Patients should use caution when driving or operating machinery (5.3)
during the titration period and at higher doses (5.1) • Falls: Monitor for falls and injuries (5.4)
• FYCOMPA should be reduced if these symptoms occur and should be • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/
discontinued immediately if symptoms are severe or are worsenin g (5.1) Multi-Organ Hypersensitivity: Discontinue if no alternate etiology (5.5)
• Withdrawal of Antiepileptic Drugs: In patients with epilepsy, there may
------------------------------INDICATIONS AND USAGE----------------------------- be an increase in seizure frequency (5.6)
FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated
-----------------------------ADVERSE REACTIONS-----------------------------
for:
Most common adverse reactions (≥5% and ≥1% higher than placebo)
• Treatment of partial-onset seizures with or without secondarily generalized include dizziness, somnolence, fatigue, irritability, falls, nausea, weight
seizures in patients with epilepsy 4 years of age and older (1.1) gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and
• Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures anxiety (6.1)
in patients with epilepsy 12 years of age and older (1.2)
To report SUSPECTED ADVERSE REACTIONS, contact Eisai at 1-
--------------------------DOSAGE AND ADMINISTRATION----------------------- 888-274-2378 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Dosing in the absence of moderate or strong CYP3A4 inducers
• Starting dose: 2 mg once daily orally at bedtime (2.1, 2.2) ------------------------------DRUG INTERACTIONS----------------------------
• May increase dose based on clinical response and tolerability by increments of • Contraceptives: 12 mg once daily may decrease the effectiveness of
2 mg once daily no more frequently than at weekly intervals (2.1, 2.2) hormonal contraceptives containing levonorgestrel (7.1)
• Recommended maintenance dose in monotherapy or adjunctive therapy for • Moderate and Strong CYP3A4 Inducers (including carbamazepine,
partial-onset seizures: 8 mg to 12 mg once daily at bedtime (2.1) oxcarbazepine, and phenytoin): increase clearance of perampanel and
• Recommended maintenance dose in adjunctive therapy for primary generalized decrease perampanel plasma concentrations. When moderate or strong
tonic-clonic seizures: 8 mg once daily at bedtime (2.2) CYP3A4 inducers are introduced or withdrawn, monitor patients
• Measure oral suspension using provided adaptor and dosing syringe (2.7) closely. Dose adjustment of FYCOMPA may be necessary (2.3, 7.2)
Dosing in the presence of concomitant moderate or strong CYP3A4 inducers: see ----------------------USE IN SPECIFIC POPULATIONS----------------------
section 2.3 Pregnancy: Based on animal data, may cause fetal harm (8.1)
Specific Populations
See 17 for PATIENT COUNSELING INFORMATION and
• Mild and Moderate Hepatic Impairment: Maximum recommended daily dose is Medication Guide.
6 mg (mild) and 4 mg (moderate) once daily at bedtime (2.4) Revised: 2/2021
• Severe Hepatic Impairment: Not recommended (2.4)
FULL PRESCRIBING INFORMATION: CONTENTS* 7.3 Alcohol and Other CNS Depressants
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL 8 USE IN SPECIFIC POPULATIONS
REACTIONS 8.1 Pregnancy
1 INDICATIONS AND USAGE 8.2 Lactation
1.1 Partial-Onset Seizures 8.3 Females and Males of Reproductive Potential
1.2 Primary Generalized Tonic-Clonic Seizures 8.4 Pediatric Use
2 DOSAGE AND ADMINISTRATION 8.5 Geriatric Use
2.1 Dosage for Partial-Onset Seizures 8.6 Hepatic Impairment
2.2 Dosage for Primary Generalized Tonic-Clonic Seizures 8.7 Renal Impairment
2.3 Dosage Modifications with Concomitant Use of Moderate or Strong 9 DRUG ABUSE AND DEPENDENCE
CYP3A4 Enzyme Inducers 9.1 Controlled Substance
2.4 Dosage Adjustment in Patients with Hepatic Impairment 9.2 Abuse
2.5 Dosage Information for Patients with Renal Impairment 9.3 Dependence
2.6 Dosage Information for Elderly Patients 10 OVERDOSAGE
2.7 Administration of Oral Suspension 11 DESCRIPTION
3 DOSAGE FORMS AND STRENGTHS 12 CLINICAL PHARMACOLOGY
4 CONTRAINDICATIONS 12.1 Mechanism of Action
5 WARNINGS AND PRECAUTIONS 12.2 Pharmacodynamics
5.1 Serious Psychiatric and Behavioral Reactions 12.3 Pharmacokinetics
5.2 Suicidal Behavior and Ideation 13 NONCLINICAL TOXICOLOGY
5.3 Neurologic Effects 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility
5.4 Falls 14 CLINICAL STUDIES
5.5 Drug Reaction with Eosinophilia and Systemic Symptoms 14.1 Partial-Onset Seizures
(DRESS)/Multiorgan Hypersensitivity 14.2 Primary Generalized Tonic-Clonic (PGTC) Seizures
5.6 Withdrawal of Antiepileptic Drugs 16 HOW SUPPLIED/STORAGE AND HANDLING
6 ADVERSE REACTIONS 16.1 How Supplied
6.1 Clinical Trials Experience 16.2 Storage
6.2 Postmarketing Experience 17 PATIENT COUNSELING INFORMATION
7 DRUG INTERACTIONS * Sections or subsections omitted from the Full Prescribing Information are not
7.1 Contraceptives listed.
7.2 Moderate and Strong CYP3A4 Inducers
FYCO-US4155FULL PRESCRIBING INFORMATION
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
• 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).
• These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or
concomitant use of medications associated with hostility and aggression (5.1).
• Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes
in mood, behavior, or personality that are not typical for the patient are observed while taking FYCOMPA or
after discontinuing FYCOMPA (5.1).
• Closely monitor patients 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).
1 INDICATIONS AND USAGE
1.1 Partial-Onset Seizures
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.
1.2 Primary Generalized Tonic-Clonic Seizures
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.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Partial-Onset Seizures
Monotherapy or Adjunctive Therapy
The recommended starting dosage of FYCOMPA in adults and pediatric patients 4 years of age and older is 2 mg once daily
taken orally at bedtime. Increase dosage no more frequently than at weekly intervals by increments of 2 mg once daily based
on individual clinical response and tolerability.
The recommended maintenance dose range is 8 mg to 12 mg once daily, although some patients may respond to a dose of
4 mg daily. A dose of 12 mg once daily resulted in somewhat greater reductions in seizure rates than the dose of 8 mg once
daily, but with a substantial increase in adverse reactions.
Dosage adjustment is recommended with concomitant use of moderate or strong CYP3A4 enzyme inducing drugs, which
include certain antiepileptic drugs (AEDs) [see Dosage and Administration (2.3)].
2.2 Dosage for Primary Generalized Tonic-Clonic Seizures
Adjunctive Therapy
The recommended starting dosage of FYCOMPA in adults and pediatric patients 12 years of age and older is 2 mg once
daily taken orally at bedtime. Increase dosage no more frequently than at weekly intervals by increments of 2 mg once daily
based on individual clinical response and tolerability.
The recommended maintenance dose is 8 mg once daily taken at bedtime. Patients who are tolerating FYCOMPA at 8 mg
once daily and require further reduction of seizures may benefit from a dose increase up to 12 mg once daily if tolerated.
Dosage adjustment is recommended with concomitant use of moderate or strong CYP3A4 enzyme inducing drugs, which
include certain AEDs [see Dosage and Administration (2.3)].
FYCO-US41552.3 Dosage Modifications with Concomitant Use of Moderate or Strong CYP3A4 Enzyme Inducers
Moderate and strong CYP3A4 inducers, including enzyme-inducing AEDs such as phenytoin, carbamazepine, and
oxcarbazepine, cause a reduction in FYCOMPA plasma levels [see Drug Interactions (7.2), Clinical Pharmacology (12.3)].
Therefore, in adults and pediatric patients 4 years of age and older receiving these concomitant enzyme-inducing drugs, the
recommended starting dosage of FYCOMPA is 4 mg once daily taken orally at bedtime.
Increase dosage by increments of 2 mg once daily based on individual clinical response and tolerability, no more frequently
than at weekly intervals. A maintenance dose has not been established in clinical trials. The highest dose studied in patients
on concomitant enzyme-inducing AEDs was 12 mg once daily.
When moderate or strong CYP3A4 inducers are introduced or withdrawn from a patient’s treatment regimen, the patient
should be closely monitored for clinical response and tolerability. Dose adjustment of FYCOMPA may be necessary.
2.4 Dosage Adjustment in Patients with Hepatic Impairment
In patients with mild and moderate hepatic impairment, the starting dose of FYCOMPA is 2 mg once daily. Increase dosage
by increments of 2 mg once daily no more frequently than every 2 weeks. The maximum recommended daily dose is 6 mg
for patients with mild hepatic impairment and 4 mg for patients with moderate hepatic impairment. FYCOMPA is not
recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.6), Clinical
Pharmacology (12.3)].
2.5 Dosage Information for Patients with Renal Impairment
FYCOMPA can be used in patients with moderate renal impairment with close monitoring. A slower titration may be
considered, based on clinical response and tolerability. FYCOMPA is not recommended in patients with severe renal
impairment or patients undergoing hemodialysis [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
2.6 Dosage Information for Elderly Patients
In elderly patients, increase dosage no more frequently than every 2 weeks during titration [see Use in Specific Populations
(8.5)].
2.7 Administration of Oral Suspension
FYCOMPA oral suspension, 0.5 mg/mL, should be shaken well before every administration. The provided adapter and
graduated oral dosing syringe should be used to administer the oral suspension. A household teaspoon or tablespoon is not
an adequate measuring device. The adapter, which is supplied in the product carton, should be inserted firmly into the neck
of the bottle before use and remain in place for the duration of the usage of the bottle. The dosing syringe should be inserted
into the adapter and the dose withdrawn from the inverted bottle. The cap should be replaced after each use. The cap fits
properly when the adapter is in place [see Instructions for Use].
Discard any unused FYCOMPA oral suspension remaining 90 days after first opening the bottle.
3 DOSAGE FORMS AND STRENGTHS
Tablets
• 2 mg tablets: orange, round, debossed with “2” on one side and “Є 275” on the other.
• 4 mg tablets: red, round, debossed with “4” on one side and “Є 277” on the other.
• 6 mg tablets: pink, round, debossed with “6” on one side and “Є 294” on the other.
• 8 mg tablets: purple, round, debossed with “8” on one side and “Є 295” on the other.
• 10 mg tablets: green, round, debossed with “10” on one side and “Є 296” on the other.
• 12 mg tablets: blue, round, debossed with “12” on one side and “Є 297” on the other.
Oral Suspension
0.5 mg/mL white to off-white opaque liquid suspension for oral administration.
4 CONTRAINDICATIONS
None.
FYCO-US41555 WARNINGS AND PRECAUTIONS
5.1 Serious Psychiatric and Behavioral Reactions
In the controlled partial-onset seizure clinical trials, hostility- and aggression-related adverse reactions occurred in 12%
and 20% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 6%
of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of
treatment, although new events continued to be observed through more than 37 weeks. FYCOMPA-treated patients
experienced more hostility- and aggression-related adverse reactions that were serious, severe, and led to dose reduction,
interruption, and discontinuation more frequently than placebo-treated patients.
In general, in placebo-controlled partial-onset seizure clinical trials, neuropsychiatric events were reported more frequently
in patients being treated with FYCOMPA than in patients taking placebo. These events included irritability, aggression,
anger, and anxiety, which occurred in 2% or greater of FYCOMPA-treated patients and twice as frequently as in placebo-
treated patients. Other symptoms that occurred with FYCOMPA and were more common than with placebo included
belligerence, affect lability, agitation, and physical assault. Some of these events were reported as serious and life-
threatening. Homicidal ideation and/or threat were exhibited in 0.1% of 4,368 FYCOMPA-treated patients in controlled and
open label trials, including non-epilepsy trials. Homicidal ideation and/or threat have also been reported postmarketing in
patients treated with FYCOMPA.
In the partial-onset seizure clinical trials, these events occurred in patients with and without prior psychiatric history, prior
aggressive behavior, or concomitant use of medications associated with hostility and aggression. Some patients experienced
worsening of their pre-existing psychiatric conditions. Patients with active psychotic disorders and unstable recurrent
affective disorders were excluded from the clinical trials. The combination of alcohol and FYCOMPA significantly
worsened mood and increased anger. Patients taking FYCOMPA should avoid the use of alcohol [see Drug Interactions
(7.3)].
Similar serious psychiatric and behavioral events were observed in the primary generalized tonic-clonic seizure clinical trial.
In healthy volunteers taking FYCOMPA, observed psychiatric events included paranoia, euphoric mood, agitation, anger,
mental status changes, and disorientation/confusional state.
In the non-epilepsy trials, psychiatric events that occurred in perampanel-treated patients more often than placebo-treated
patients included disorientation, delusion, and paranoia.
In the postmarketing setting, there have been reports of psychosis (acute psychosis, hallucinations, delusions, paranoia) and
delirium (delirium, confusional state, disorientation, memory impairment) in patients treated with FYCOMPA [see Adverse
Reactions (6.2)].
Patients, their caregivers, and families should be informed that FYCOMPA may increase the risk of psychiatric events.
Patients should be monitored during treatment and for at least 1 month after the last dose of FYCOMPA, and especially
when taking higher doses and during the initial few weeks of drug therapy (titration period) or at other times of dose
increases. Dose of FYCOMPA should be reduced if these symptoms occur. Permanently discontinue FYCOMPA for
persistent severe or worsening psychiatric symptoms or behaviors and refer for psychiatric evaluation.
5.2 Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including FYCOMPA, increase the risk of suicidal thoughts or behavior in patients taking these
drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or
worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that
patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI: 1.2, 2.7) of
suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment
duration of 12 weeks, the estimated incidence of suicidal behavior or ideation among 27,863 AED-treated patients was
0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of
suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials
and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
FYCO-US4155The increased risk of suicidal thoughts or behavior with AEDs was observed as early as 1 week after starting drug treatment
with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend
beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased
risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs
used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed.
Table 1 shows absolute and relative risk by indication for all evaluated AEDs.
Table 1. Risk by indication for antiepileptic drugs in the pooled analysis
Relative Risk:
Risk Difference:
Placebo Patients Drug Patients Incidence of Events
Additional Drug
Indication with Events per with Events per in drug Patients/
Patients with Events
1000 Patients 1000 patients Incidence in
per 1000 Patients
Placebo Patients
Epilepsy 1.0 3.4 3.5 2.4
Psychiatric 5.7 8.5 1.5 2.9
Other 1.0 1.8 1.9 0.9
Total 2.4 4.3 1.8 1.9
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for
psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing FYCOMPA or any other AED must balance the risk of suicidal thoughts or behavior with
the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated
with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior
emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient
may be related to the illness being treated.
5.3 Neurologic Effects
Dizziness and Gait Disturbance
FYCOMPA caused dose-related increases in events related to dizziness and disturbance in gait or coordination [see Adverse
Reactions (6.1)]. In the controlled partial-onset seizure clinical trials, dizziness and vertigo were reported in 35% and 47%
of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 10% of
placebo-treated patients. The gait disturbance related events (including ataxia, gait disturbance, balance disorder, and
abnormal coordination) were reported in 12% and 16% of patients randomized to receive FYCOMPA at doses of 8 mg and
12 mg per day, respectively, compared to 2% of placebo-treated patients. Elderly patients had an increased risk of these
adverse reactions compared to younger adults and pediatric patients.
These adverse reactions occurred mostly during the titration phase and led to discontinuation in 3% of FYCOMPA-treated
patients compared to 1% of placebo-treated patients.
These adverse reactions were also observed in the primary generalized tonic-clonic seizure clinical trial.
Somnolence and Fatigue
FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events (including fatigue, asthenia, and
lethargy).
In the controlled partial-onset seizure clinical trials, 16% and 18% of patients randomized to receive FYCOMPA at doses
of 8 mg and 12 mg per day, respectively, reported somnolence compared to 7% of placebo patients. In the controlled partial-
onset seizure clinical trials, 12% and 15% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg per
day, respectively, reported fatigue-related events compared to 5% of placebo patients. Somnolence or fatigue-related events
FYCO-US4155led to discontinuation in 2% of FYCOMPA-treated patients and 0.5% of placebo-treated patients. Elderly patients had an
increased risk of these adverse reactions compared to younger adults and pediatric patients.
In the controlled partial-onset seizure clinical trials, these adverse reactions occurred mostly during the titration phase.
These adverse reactions were also observed in the primary generalized tonic-clonic seizure clinical trial.
Risk Amelioration
Prescribers should advise patients against engaging in hazardous activities requiring mental alertness, such as operating
motor vehicles or dangerous machinery, until the effect of FYCOMPA is known. Patients should be carefully observed for
signs of central nervous system (CNS) depression, such as somnolence and sedation, when FYCOMPA is used with other
drugs with sedative properties because of potential additive effects.
5.4 Falls
An increased risk of falls, in some cases leading to serious injuries including head injuries and bone fracture, occurred in
patients being treated with FYCOMPA (with and without concurrent seizures). In the controlled partial-onset seizure clinical
trials, falls were reported in 5% and 10% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day,
respectively, compared to 3% of placebo-treated patients. Falls were reported as serious and led to discontinuation more
frequently in FYCOMPA-treated patients than placebo-treated patients. Elderly patients had an increased risk of falls
compared to younger adults and pediatric patients.
5.5 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan hypersensitivity, has been
reported in patients taking antiepileptic drugs, including FYCOMPA. DRESS may be fatal or life-threatening. DRESS
typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with
other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis
sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its
expression, other organ systems not noted here may be involved. It is important to note that early manifestations of
hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or
symptoms are present, the patient should be evaluated immediately. FYCOMPA should be discontinued if an alternative
etiology for the signs or symptoms cannot be established.
5.6 Withdrawal of Antiepileptic Drugs
There is the potential of increased seizure frequency in patients with seizure disorders when antiepileptic drugs are
withdrawn abruptly. FYCOMPA has a half-life of approximately 105 hours so that even after abrupt cessation, blood levels
fall gradually. In epilepsy clinical trials FYCOMPA was withdrawn without down-titration. Although a small number of
patients exhibited seizures following discontinuation, the data were not sufficient to allow any recommendations regarding
appropriate withdrawal regimens. A gradual withdrawal is generally recommended with antiepileptic drugs, but if
withdrawal is a response to adverse events, prompt withdrawal can be considered.
6 ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in the labeling:
• Serious Psychiatric and Behavioral Reactions [see Warnings and Precautions (5.1)]
• Suicidal Behavior and Ideation [see Warnings and Precautions (5.2)]
• Neurologic Effects [see Warnings and Precautions (5.3)]
• Falls [see Warnings and Precautions (5.4)]
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings
and Precautions (5.5)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials
of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in
clinical practice.
FYCO-US4155Partial-Onset Seizures
Adult and Adolescent Patients (12 years of age and older)
A total of 1,038 patients receiving FYCOMPA (2, 4, 8, or 12 mg once daily) constituted the safety population in the pooled
analysis of the placebo-controlled trials (Studies 1, 2, and 3) in patients with partial-onset seizures. Approximately 51% of
patients were female, and the mean age was 35 years.
Adverse Reactions Leading to Discontinuation
In controlled clinical trials (Studies 1, 2, and 3), the rate of discontinuation as a result of an adverse reaction was 3%, 8%,
and 19% in patients randomized to receive FYCOMPA at the recommended doses of 4 mg, 8 mg, and 12 mg per day,
respectively, and 5% in patients randomized to receive placebo [see Clinical Studies (14)]. The adverse reactions most
commonly leading to discontinuation (≥1% in the 8 mg or 12 mg FYCOMPA group and greater than placebo) were dizziness,
somnolence, vertigo, aggression, anger, ataxia, blurred vision, irritability, and dysarthria [see Warnings and Precautions
(5.1, 5.3)].
Most Common Adverse Reactions
Table 2 gives the incidence in the controlled clinical trials (Studies 1, 2, and 3) of the adverse reactions that occurred in
≥2% of patients with partial-onset seizures in the FYCOMPA 12 mg dose group and more frequent than placebo (in order
of decreasing frequency for the 12 mg dose group).
The most common dose-related adverse reactions in patients receiving FYCOMPA at doses of 8 mg or 12 mg (≥4% and
occurring at least 1% higher than the placebo group) included dizziness (36%), somnolence (16%), fatigue (10%), irritability
(9%), falls (7%), nausea (7%), ataxia (5%), balance disorder (4%), gait disturbance (4%), vertigo (4%), and weight gain
(4%). For almost every adverse reaction, rates were higher on 12 mg and more often led to dose reduction or discontinuation.
Table 2. Adverse Reactions in Pooled Placebo-Controlled Trials in Adult and Adolescent Patients with Partial-
Onset Seizures (Studies 1, 2, and 3) (Reactions ≥ 2% of Patients in Highest FYCOMPA Dose (12 mg) Group and
More Frequent than Placebo)
FYCOMPA
Placebo
4 mg 8 mg 12 mg
n=442
% n=172 n=431 n=255
% % %
Dizziness 9 16 32 43
Somnolence 7 9 16 18
Headache 11 11 11 13
Irritability 3 4 7 12
Fatigue 5 8 8 12
Falls 3 2 5 10
Ataxia 0 1 3 8
Nausea 5 3 6 8
Vertigo 1 4 3 5
Back pain 2 2 2 5
Dysarthria 0 1 3 4
Anxiety 1 2 3 4
Blurred vision 1 1 3 4
Gait disturbance 1 1 4 4
Weight gain 1 4 4 4
Cough 3 1 1 4
Upper respiratory tract infection 3 3 3 4
Vomiting 3 2 3 4
Hypersomnia 0 1 2 3
AngerFYCOMPA
Placebo
4 mg 8 mg 12 mg
n=442
n=172 n=431 n=255
%
% % %
Head injury 1 1 1 3
Hypoaesthesia 1 0 0 3
Pain in extremity 1 0 2 3
Constipation 2 2 2 3
Myalgia 2 1 1 3
Coordination abnormal 0 1Table 3. Adverse Reactions in a Placebo-Controlled Trial in Patients with Primary Generalized Tonic-Clonic
Seizures (Study 4) (Reactions ≥ 4% of Patients in FYCOMPA Group and More Frequent than Placebo)
Placebo FYCOMPA 8 mg
n=82 n=81
% %
Dizziness 6 32
Fatigue 6 15
Headache 10 12
Somnolence 4 11
Irritability 2 11
Vertigo 2 9
Vomiting 2 9
Weight gain 4 7
Contusion 4 6
Nausea 5 6
Abdominal pain 1 5
Anxiety 4 5
Urinary tract infection 1 4
Ligament sprain 0 4
Balance disorder 1 4
Rash 1 4
Weight Gain
Weight gain has occurred with FYCOMPA.
In controlled partial-onset seizure clinical trials, FYCOMPA-treated adults gained an average of 1.1 kg (2.5 lbs) compared
to an average of 0.3 kg (0.7 lbs) in placebo-treated adults with a median exposure of 19 weeks. The percentages of adults
who gained at least 7% and 15% of their baseline body weight in FYCOMPA-treated patients were 9.1% and 0.9%,
respectively, as compared to 4.5% and 0.2% of placebo-treated patients, respectively. Clinical monitoring of weight is
recommended.
Similar increases in weight were also observed in adult and adolescent patients treated with FYCOMPA in the primary
generalized tonic-clonic seizure clinical trial.
Elevated triglycerides
Increases in triglycerides have occurred with FYCOMPA use.
Comparison of Sex and Race
No significant sex differences were noted in the incidence of adverse reactions.
Although there were few non-Caucasian patients, no differences in the incidence of adverse reactions compared to
Caucasian patients were observed.
6.2 Postmarketing Experience
The following adverse reactions have been identified during post approval use of FYCOMPA. Because these reactions
are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency
or establish a causal relationship to drug exposure.
Dermatologic: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.5)]
Psychiatric: Acute psychosis, hallucinations, delusions, paranoia, delirium, confusional state, disorientation, memory
impairment [see Warnings and Precautions (5.1)].
FYCO-US41557 DRUG INTERACTIONS
7.1 Contraceptives
With concomitant use, FYCOMPA at a dose of 12 mg per day reduced levonorgestrel exposure by approximately 40% [see
Clinical Pharmacology (12.3)]. Use of FYCOMPA with contraceptives containing levonorgestrel may render them less
effective. Additional non-hormonal forms of contraception are recommended [see Use in Specific Populations (8.3)].
7.2 Moderate and Strong CYP3A4 Inducers
The concomitant use of known moderate and strong CYP3A4 inducers including carbamazepine, phenytoin, or
oxcarbazepine with FYCOMPA decreased the plasma levels of perampanel by approximately 50-67% [see Clinical
Pharmacology (12.3)]. The starting doses for FYCOMPA should be increased in the presence of moderate or strong
CYP3A4 inducers [see Dosage and Administration (2.3)].
When these moderate or strong CYP3A4 inducers are introduced or withdrawn from a patient’s treatment regimen, the
patient should be closely monitored for clinical response and tolerability. Dose adjustment of FYCOMPA may be necessary
[see Dosage and Administration (2.3)].
7.3 Alcohol and Other CNS Depressants
The concomitant use of FYCOMPA and CNS depressants including alcohol may increase CNS depression. A
pharmacodynamic interaction study in healthy subjects found that the effects of FYCOMPA on complex tasks such as
driving ability were additive or supra-additive to the impairment effects of alcohol [see Clinical Pharmacology (12.3)].
Multiple dosing of FYCOMPA 12 mg per day also enhanced the effects of alcohol to interfere with vigilance and alertness,
and increased levels of anger, confusion, and depression. These effects may also be seen when FYCOMPA is used in
combination with other CNS depressants. Care should be taken when administering FYCOMPA with these agents. Patients
should limit activity until they have experience with concomitant use of CNS depressants (e.g., benzodiazepines, narcotics,
barbiturates, sedating antihistamines). Advise patients not to drive or operate machinery until they have gained sufficient
experience on FYCOMPA to gauge whether it adversely affects these activities.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
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 of major birth defects and miscarriage in clinically recognized
pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the
indicated population is unknown.
Data
Animal Data
Oral administration of perampanel (1, 3, or 10 mg/kg/day) to pregnant rats throughout organogenesis resulted in an
increase in visceral abnormalities (diverticulum of the intestine) at all doses tested; maternal toxicity was observed at the
mid and high doses. In a dose-ranging study at higher oral doses (10, 30, or 60 mg/kg/day), embryo lethality and reduced
fetal body weight were observed at the mid and high doses tested. The lowest dose tested (1 mg/kg/day) is similar to a
human dose of 8 mg/day based on body surface area (mg/m2 ).
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