It could be a sign of PseudoBulbar Affect (PBA)
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For people with certain neurologic conditions or brain injuries
Uncontrollable Uncontrollable
crying? laughing?
It could be a sign of
PseudoBulbar Affect (PBA)
There are risks associated with using NUEDEXTA. Please see Important
Safety Information inside and accompanying full Prescribing Information.
Table of Contents
About uncontrollable crying or laughing 4-5
What is PseudoBulbar Affect (PBA)?
Who gets PBA?
Science of PBA
Understanding PBA Symptoms 6-7
An emotional disconnect
PBA & Depression
Control PBA symptoms with NUEDEXTA® 8-9
What is NUEDEXTA?
How does it work?
NUEDEXTA is clinically proven
Taking NUEDEXTA 10-11 Welcome!
Getting the most from your treatment You’re about to learn about PBA and NUEDEXTA
NUEDEXTA patient support and savings 12-13 (dextromethorphan hydrobromide and quinidine
sulfate) 20 mg/10mg capsules.
Important Safety Information for patients 14-15
Understanding if you have PBA 16-18 Nuedexta is the first and only prescription
Do I Have PBA assessment tool medication specifically approved by the FDA to treat
Understanding how PBA is affecting you PseudoBulbar Affect (PBA).
Learning the facts 19-20 Pronunciation: SOO-doh-BUHL-bahr AF-ekt
Frequently asked questions
Prepare for doctor visits
Read a patient’s PBA story 21
NUEDEXTA is not approved to treat emotional symptoms
other than involuntary crying and/or laughing that may
occur with certain neurologic conditions.
Please see Important Safety Information on pages 14-15
2 and accompanying full Prescribing Information.
What is PBA? The Science of PBA
PseudoBulbar Affect (PBA) is a neurologic condition PBA was first described in medical literature more
that can occur when certain neurologic diseases than 130 years ago by Charles Darwin. Over the
or brain injuries damage the areas of the brain that years, doctors have called PBA by different names
control normal expression of emotion. This damage such as “emotional incontinence” or “pathological
can disrupt brain signaling, causing a ‘short circuit’ laughing and crying.” Though the names may
and triggering episodes of crying or laughing that are change, the symptoms are the same.
often sudden and exaggerated or do not match what
the person is feeling inside.
Who gets PBA? Motor
cortex
Though you may have never heard of PBA prior to Frontal and
temporal cortex
your diagnosis, you’re not alone. Nearly two million
Americans with certain neurologic conditions or
brain injuries are estimated to suffer from it. PBA
doesn’t discriminate. It can affect men and women, Cerebellum
old and young. Network disrupted
Conditions or injuries that can lead to PBA include: Brainstem
Certain underlying
– Alzheimer’s disease or other dementias neurologic conditions “Bulb”
may cause damage
– Stroke that disrupts the Involuntary
– Traumatic brain injury (TBI) normal control of laughing/crying
– Multiple sclerosis (MS) emotional expression.
– Parkinson’s disease
One of the jobs of the brain is to figure out how we
– Lou Gehrig’s disease (ALS)
feel in the moment. That information is then sent
down to the brainstem, also known as the “bulb.”
The brainstem then sends signals to the face and
other parts of the body that show emotion. PBA is
believed to be the result of a disruption of these
signals.
To learn more, visit NUEDEXTA.com
Please see Important Safety Information on pages 14-15
4 and accompanying full Prescribing Information. 5
“Once my daughter
fell and hurt herself,
PBA & Depression
and I couldn’t PBA is not depression. However, some patients may
stop laughing.” have both conditions. PBA and depression should be
diagnosed separately for appropriate treatment.
—Bernadetta B.,
PBA patient Talk with your doctor.
taking NUEDEXTA
Clinical PBA Depression
Characteristics
Emotional Crying, laughing, Crying
expression or both
Underlying Neurologic disease May or may not
neurologic or brain injury have underlying
condition always present neurologic disorder
An Emotional Disconnect Episode length
of time
Seconds to
minutes; brief
Weeks to months;
on-going mood
Patients with PBA describe uncontrollable outbursts Ability to control Uncontrollable May be moderated
of crying or laughing that aren’t connected to the episodes or controlled
way they’re feeling inside. One telltale sign of a PBA
Emotional Exaggerated or Emotions match
episode is that the outburst is inappropriate for the experience does not match mood of sadness
situation. Many patients tell stories of laughing at feelings inside inside
funerals or crying when they heard something that
Accompanying Outbursts have no Worthlessness,
actually made them happy. thoughts specific link to hopelessness,
underlying thoughts thoughts of death
In other situations, the emotions may be appropriate,
but they’re exaggerated – they’re more intense
or last longer than is called for. It’s common for
people to cry when they see a touching movie or TV
commercial, but a person with PBA may sob deeply
Uncontrollable Uncontrollable
and excessively for a long time. crying? laughing?
Please see Important Safety Information on pages 14-15
6 and accompanying full Prescribing Information. 7
Help control PBA with
NUEDEXTA “With NUEDEXTA,
the crying episodes
NUEDEXTA is the first and only prescription have gone way
medication specifically approved to treat the
down.”
symptoms of PBA, uncontrollable crying and/or
—Charles D., PBA
laughing. It is not an antidepressant and is not patient taking
approved to treat depression or other emotional NUEDEXTA
symptoms that may occur with certain neurologic
conditions.
NUEDEXTA is made up of dextromethorphan and
quinidine, two known medicines that have been used Individual results may vary
separately to treat conditions other than PBA.
NUEDEXTA is thought to act on areas of the
brain responsible for emotional responses. With
NUEDEXTA, episodes of unwanted crying or
NUEDEXTA is
laughing can be reduced or eliminated altogether clinically proven
for some patients.
In clinical trials, many patients experienced
fewer PBA episodes after the first week of taking
Important Safety Information NUEDEXTA. What’s more, many patients were
completely free of PBA episodes by the end of the
NUEDEXTA and certain other medicines can interact,
study. Your results may vary.
causing serious side effects. If you take certain drugs
or have certain heart problems, NUEDEXTA may not Tell your doctor if your PBA episodes continue or
be right for you. Tell your doctor if you or a family get worse. You should periodically reassess the
member has ever had any heart disease or problems. need for treatment as PBA symptoms may
These are not all the possible risks of NUEDEXTA. sometimes improve on their own.
To learn more, visit NUEDEXTA.com
Please see Important Safety Information on pages 14-15
8 and accompanying full Prescribing Information. 9
Taking NUEDEXTA “I wanted more
Only your doctor can decide if NUEDEXTA is right control over my
PBA outbursts...
for you. Take NUEDEXTA exactly as your doctor
and with NUEDEXTA
prescribes it. I got it.”
—David D., PBA
Day 1-7 patient taking
For the first week, take 1 capsule each morning. NUEDEXTA
Day 8 12 hours
Beginning on day 8, increase your dose to 2 capsules
per day – 1 capsule every 12 hours.
Individual results may vary
NUEDEXTA may be taken with or without food.
If you forget to take 1 or more capsules, do not take
a double dose. Take your next dose of NUEDEXTA in
Important Safety Information
the prescribed amount at the usual time. Do not take The most common side effects of NUEDEXTA are
more than 2 capsules in a 24-hour period. Make sure diarrhea, dizziness, cough, vomiting, weakness,
that 12 hours pass between doses. swelling of feet and ankles, urinary tract infection,
feeling like you have the flu, elevated liver enzyme,
Continuing on NUEDEXTA and gas. These side effects were seen in 13% or
less of patients taking NUEDEXTA. These are not
It is important to continue your treatment as
all the possible risks of NUEDEXTA. Tell your doctor
prescribed by your doctor. Your doctor may want to
about any side effect that bothers you or does not
periodically evaluate whether you need to continue
go away.
your treatment. In some cases, PBA symptoms may
improve on their own over time.
To learn more, visit NUEDEXTA.com
Please see Important Safety Information on pages 14-15
10 and accompanying full Prescribing Information. 11
NUEDEXTA patient – NUEDEXTA Patient Assistance Program
If you are prescribed NUEDEXTA and have limited
support and savings income and little to no insurance or prescription drug
coverage, you may be eligible to receive NUEDEXTA
Avanir Pharmaceuticals, the maker of NUEDEXTA, is for free.
committed to supporting patients with PBA. – Reimbursement support
The Nuedexta patient support team can help with your
an $ 30* insurance reimbursement questions and assisting with
Pay no More Th
For your next NU
EDEXTA prescripti
on and refills. Restric
tions apply.
rse)
(see reve
any required paperwork.
RxBIN: 610524
Loyalty
Useful tools
RxPCN:
RxGRP: 50776185
ISSUER: (80840)
ID:
Go to www.NUEDEXTA.com to get access to these
s of copay
applies regardles s apply.
*Benefit cap iction
amount. Other restr
useful tools:
– Co-pay savings card – Episode Tracker. This convenient weekly chart is a
If you have private insurance, the NUEDEXTA co-pay great way to monitor the effects of NUEDEXTA on your
savings card will allow you to pay no more than $30 for PBA episodes.
your next NUEDEXTA prescriptions and refills. To get your – Medicines Chart. Use this form to list all the
co-pay savings card, visit www.NUEDEXTAsavings.com. medications you’re currently taking, Share this list with
Certain restrictions may apply. your doctor during each visit.
– Out-of-pocket Assistance Program – – Hear from others who know exactly what you’re
Medicare Part D going through. The NUEDEXTA website features
Avanir supports Patient Services, Inc. (PSI), a national personal stories and videos of PBA patients and their
nonprofit organization that provides financial assistance caregivers who share firsthand experiences with PBA
to patients with chronic illnesses. If you have Medicare and how NUEDEXTA has helped them.
Part D insurance and cannot afford your out-of-pocket
Scan this tag to go to NUEDEXTA.com to hear
costs for medication, PSI may be able to help. the personal stories of patients with PBA and
their loved ones.
To learn more, visit NUEDEXTA.com
or call 1-855-4Nuedex [468-3339]
Please see Important Safety Information on pages 14-15
12 and accompanying full Prescribing Information. 13Important Safety Information
for patients
NUEDEXTA® (dextromethorphan hydrobromide and doctor if you or a family member has or ever had any heart
quinidine sulfate) 20mg/10mg capsules are approved disease or problems. If you have certain heart problems,
for the treatment of pseudobulbar affect (PBA). PBA NUEDEXTA may not be right for you. Your doctor may
is a medical condition that causes sudden, frequent test your heart rhythm (heartbeats) before you start
and involuntary bouts of crying and/or laughing in NUEDEXTA. If you feel faint or lose consciousness, call
people living with certain neurologic conditions or brain your doctor right away.
injuries. Studies to support the approval of NUEDEXTA
NUEDEXTA may make you dizzy. Be extra careful not
were done in patients with multiple sclerosis (MS) or
to fall, especially if you have a hard time walking or a
amyotrophic lateral sclerosis (ALS). An additional safety
problem with falling.
study included a variety of other neurologic populations.
NUEDEXTA is not approved to treat emotional symptoms The most common side effects of NUEDEXTA are
other than involuntary crying and/or laughing that may diarrhea, dizziness, cough, vomiting, weakness, swelling
occur with certain neurologic conditions. of feet and ankles, urinary tract infection, feeling like
you have the flu, abnormal liver tests, and gas. These
NUEDEXTA and certain other medicines can interact
side effects were seen in 13% or less of patients taking
causing serious side effects. People taking MAOIs
NUEDEXTA. Those are not all the possible risks of
(within the preceding or following 14 days), quinidine, or
NUEDEXTA. Tell your doctor about any side effect that
quinidine related drugs, and certain other medications
bothers you or does not go away.
should not take NUEDEXTA. Tell your doctor about
all medicines, herbal supplements, and vitamins you For more information please refer to the
are taking before you start or while you are taking accompanying full Prescribing Information or visit
NUEDEXTA. NUEDEXTA.com. This important safety information is
not meant to replace discussions with your doctor.
Some people can have an allergic reaction to
NUEDEXTA. Call your doctor right away if you experience You are encouraged to report negative side effects
lightheadedness, chills, fever, nausea, or vomiting while of prescription drugs to the FDA. Visit www.fda.gov/
taking NUEDEXTA. medwatch or call 800-FDA-1088.
NUEDEXTA may cause serious side effects, including
changes in heart rhythm (QTc prolongation). Tell your
To learn more, visit NUEDEXTA.com
14 Please see accompanying full Prescribing Information. 15Are PBA episodes Do I have PBA?
affecting you? The PBA assessment was developed by healthcare The Center for Neurologic Study-Lability Scale
professionals and is called the Center for Neurologic (CNS-LS).
In the last week, Study Lability Scale (CNS-LS). Simply answer the 7
Using the scale below, please write the number that
– Have you avoided spending time with family or questions and add up your score. If it’s 13 or higher,
describes the degree to which each item applies to
friends because of unpredictable episodes of that may suggest you are having PBA symptoms.
you DURING THE PAST WEEK. Write only 1 number
crying or laughing? This assessment tool is not intended to substitute
for each item.
for professional medical assessment and/or advice.
– Have you found yourself crying in an inappropriate Please consult with your doctor. Applies Applies Applies Applies Applies most
situation and been unable to control it? never rarely occasionally frequently of the time
1 2 3 4 5
– Have friends or family told you that you seem to
laugh at things that really aren’t funny?
Take the assessment
Assessment Questions Answers
Fill out this PBA assessment and take it to
– Have there been situations where you felt fine
your doctor. T here are times when I feel fine one minute,
one minute then were crying the next for no 1 and then I’ll become tearful the next over
apparent reason? Name: something small or for no reason at all.
Others have told me that I seem to become
– Have your found yourself being easily overcome Date of assessment: amused very easily or that I seem to
2 become amused about things that really
by crying or laughing?
Underlying Neurological Condition: aren’t funny.
If you answered “yes” to any of these questions, ❑ Alzheimer’s Disease or Dementia 3 I find myself crying very easily.
take the short assessment for PBA here and share ❑ Stroke I find that even when I try to control my
the results with your doctor. 4 laughter, I am often unable to do so.
❑ Traumatic Brain Injury (TBI)
T here are times when I won’t be thinking
❑ Multiple Sclerosis (MS) of anything happy or funny at all, but then
5 I’ll suddenly be overcome by funny or
❑ Parkinson’s Disease happy thoughts.
❑ Lou Gehrig’s Disease (ALS) I find that even when I try to control my
6 crying, I am often unable to do so.
❑ Other Neurologic Condition
7 I find that I am easily overcome by laughter.
TOTAL SCORE
Please see accompanying The PBA Assessment tool has been validated in ALS and
16 full Prescribing Information. MS patient populations. Please consult with your doctor. 17 18Frequently asked questions Ask your doctor
about NUEDEXTA Before considering any medication, you should speak
“I feel better
knowing there are
How does NUEDEXTA treat PBA? with your doctor to make sure it’s right for you. other people going
– A lthough the exact way in which NUEDEXTA works Below you’ll find a list of discussion points to bring to through this and that
in people is unknown, it is thought to act on areas of your next appointment. we can actually get
the brain responsible for emotional responses and is
some help.”
– Do you think I have PBA?
specifically targeted to treat PBA.
– How is PBA different from depression? —Shevoney D., PBA
How long does it take NUEDEXTA to start working? patient taking
– Can NUEDEXTA help me control my
– In a clinical trial, many patients experienced NUEDEXTA
PBA outbursts?
fewer PBA episodes after the first week of taking
NUEDEXTA. Your individual results may vary. – What can I expect from taking NUEDEXTA?
—Richard A., PBA
Do I continue to take my other medicines? – Can I safely continue to take my other patient taking NUEDEXTA Individual results
Individual may may
results vary vary
– Y our doctor may prescribe NUEDEXTA in addition to medications along with NUEDEXTA?
or in place of other medications you may be taking.
–N
UEDEXTA and certain other medicines can Important Safety Information
Richard’s PBA Story
Scan this tag to go to NUEDEXTA.com to hear
interact causing serious side effects. Be sure to tell Back in 2004 when I was on vacation with Rose the personal stories of Shevoney and other
your doctor about all medicines, supplements and NUEDEXTA 20 mg/10 mg capsules are approved for and the kids, I was hit by a drunk driver. As a result, patients with PBA and their loved ones.
vitamins that you take before starting NUEDEXTA. the treatment of PBA. PBA is a medical condition I suffered a traumatic brain injury. Since then, I’ve
Before starting a new medicine, remind your that causes sudden, frequent and involuntary bouts struggled with a lot of physical and neurologic
of crying and/or laughing in people living with certain issues. But the crying outbursts were really hard
doctor if you are taking NUEDEXTA.
neurologic conditions or brain injury. NUEDEXTA is on all of us. It’s embarrassing for a grown man to Questions?
What are the most common side effects? just suddenly burst into tears, especially in social Call 1-855-4NUEDEX (468-3339)
not approved to treat emotional symptoms other than
– T he most common side effects of NUEDEXTA are situations. I was lucky that my doctor knew this
involuntary crying and/or laughing that may occur was pseudobulbar affect (PBA) and prescribed
or visit NUEDEXTA.com
diarrhea, dizziness, cough, vomiting, weakness,
with certain neurologic conditions. NUEDEXTA because it has really helped minimize
swelling of feet and ankles, urinary tract infection, Please see Important Safety Information on pages 14-15
NUEDEXTA and certain other medicines can interact, the outbursts. Individual results may vary. and accompanying full Prescribing Information.
feeling like you have the flu, elevated liver enzymes
and gas. The side effects were seen in 13% or causing serious side effects. If you take certain
less of patients taking NUEDEXTA. Side effects of drugs or have certain heart problems, NUEDEXTA
NUEDEXTA tend to be mild to moderate and generally may not be right for you. These are not all the
decrease over time. Tell your doctor about any side possible risks of NUEDEXTA. Scan this tag to hear
effect that bothers you or does not go away. Richard and Rose share © 2012 Avanir Pharmaceuticals, Inc.
their experience with PBA All Rights Reserved. NUE-0581-BRO-0114
Please see Important Safety Information on pages 14-15 and
and NUEDEXTA.
19 accompanying full Prescribing Information. 20 21You can also read
