PBA is treatable. Learn more inside.

For people with certain neurologic conditions or brain injurySudden, frequent, and uncontrollable crying and/or laughing that doesn’t match how they feel may be a sign of PseudoBulbar Affect (PBA)

Inside you will find information to help you learn more about PBA and have a productive conversation with your doctor. Be sure to take the quiz, and then print this brochure to bring it to your next appointment.

Please see enclosed Important Safety Information and Brief Summary of Important Facts.

Actor portrayal

2

1 Understanding PBAPBA basics 3–4

What PBA is—and isn’t 5–6

2 Could it be PBA?What to ask 7

Take the quiz 7–8

3 How NUEDEXTA can helpTreating PBA with NUEDEXTA 9

How to take NUEDEXTA 10

Savings and support 11

Helpful tools 12

FAQs 13

PseudoBulbar Affect pronunciation:SUE-doh-BUHL-buhr AF-ekt

Here’s what you need to know about PBA crying and/or laughing episodes.

NUEDEXTA® was approved by the FDA in 2010 as the first and only prescription medication to treat PseudoBulbar Affect (PBA).

What is NUEDEXTA® approved for?NUEDEXTA® is approved for the treatment of PseudoBulbar Affect (PBA). PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain injury. PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury. NUEDEXTA is only available by prescription.

Please see enclosed Brief Summary of Important Facts.

Please see enclosed Brief Summary of Important Facts. 3

Who gets PBA? PBA affects almost 2 million people in the US who have certain neurologic conditions or traumatic brain injury.*

Conditions or injuries that can lead to PBA include†:

• TBI (traumatic brain injury)

• Alzheimer’s disease/dementia

• Stroke

• MS (multiple sclerosis)

• ALS (Lou Gehrig’s disease)

• Parkinson’s disease

Understanding PBAPseudoBulbar Affect (PBA) is a condition that causes sudden, frequent, and uncontrollable episodes of crying and/or laughing that don’t match how you feel. It is a secondary condition that can happen as a result of certain neurologic conditions or brain injury.

When the brain is working normally, appropriate expression of emotion such as laughing or crying occurs. Certain neurologic conditions or brain injury may cause damage to the pathways in the brain that tell your body when or how much to laugh or cry. Disruption in these pathways can lead to symptoms of PBA.

* Work SS, Colamonico JA, Bradley WG, Kaye RE. Pseudobulbar affect: an under-recognized and under-treated neurological disorder. Adv Ther. 2011;28:586-601.

† This is not a complete list. Other neurologic conditions have also been associated with PBA.

Important Safety InformationBefore you take NUEDEXTA, tell your doctor:• If you are taking monoamine oxidase

inhibitors (MAOIs), quinidine, or quinidine-related drugs. These can interact with NUEDEXTA causing serious side effects. MAOIs cannot be taken within 14 days before or after taking NUEDEXTA.

• If you have previously had an allergic reaction to dextromethorphan, quinidine or quinidine-like drugs.

• About all medicines, herbal supplements, and vitamins you take as NUEDEXTA and certain other medicines can interact causing side effects.

Feelings Signals Crying orlaughing match

how you feel

Signaldisruption

Crying or laughingis exaggerated or doesn’t

match how you feel

Feelings

PBA

The brain’s process

Please see enclosed Brief Summary of Important Facts. 4

The science of PBAThink of the brain as having circuits. When the circuits work normally:

• Our thoughts and emotions become signals that travel to the brainstem, or bulb (the “bulbar” part of pseudobulbar affect)

• These are sent to the face and other parts of the body to help us express emotion such as crying and laughing through face muscles and other body areas

But in people with certain neurologic conditions or brain injury:

• There may be damage in the brain that disrupts the signals that tell a person’s body when or how much to cry or laugh

• This damage may trigger frequent episodes of uncontrollable crying and/or laughing that are sudden and exaggerated or do not match what a person is feeling

Important Safety Information (continued)

• If you have certain heart problems, NUEDEXTA may not be right for you. Your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA.

Important Safety Information (continued)Before you take NUEDEXTA, tell your doctor:• If you have had heart disease or have a

family history of heart rhythm problems. NUEDEXTA may cause serious side effects, including changes in heart rhythm.

Please see enclosed Brief Summary of Important Facts. 5

PBA is......not depression

People may have both PBA and depression. PBA and depression are

separate conditions. Both are treatable and should be diagnosed.

...not the same as your neurologic conditionPBA is a distinct condition.

...not a sign that you are “going crazy”Many people with this condition are

relieved to learn they are not alone— and that their PBA is treatable.

Recognizing PBAPeople with PBA experience sudden, frequent, and uncontrollable episodes of crying and/or laughing that don’t match how they’re feeling.

These episodes are often:

ExaggeratedThey may be more intense or last longer

than expected. For example, a person may cry easily or for a long time after seeing a

touching movie or laugh at a joke long after others have stopped.

MismatchedThey may not fit the situation or how a

person is feeling. For example, a person might laugh at a funeral or cry when

a friend shares good news.

What PBA is not While PBA always occurs secondary to another neurologic condition or brain injury, it’s important to recognize that PBA is a separate condition with its own symptoms.

Important Safety Information (continued)Before you take NUEDEXTA, tell your doctor:• If you have myasthenia gravis.

Please see enclosed Brief Summary of Important Facts. 6

†This is not a complete list. Other neurologic conditions may be associated with PBA.‡Tearfulness/crying is not a diagnostic hallmark for depression diagnosis.§ Diagnosis can only be made by a qualified healthcare professional. These are not all the symptoms of depression.

* Formal diagnosis of PBA or depression can only be made by a qualified healthcare professional (HCP). These are not all of the diagnostic features of depression or PBA. PBA occurs in the context of a neurologic condition/injury affecting the brain and is not explained by other causes such as medication use.

PBA*

Underlying Condition

Occurs in people with a brain injury or neurologic conditions, such as TBI, Alzheimer’s and

dementia, stroke, MS, Parkinson’s, and ALS†

Symptoms

Sudden, frequent crying and/or laughing

Duration

Brief crying and/or laughing episodes last seconds to minutes

Episode Control

Crying and/or laughing episodes are uncontrollable

Behavior vs Feelings

Crying and/or laughing are exaggerated or do not match how you feel

Accompanying Thoughts

Episodes may not be related to a happy or depressed mood

Depression*

Underlying Condition

May or may not have an underlying neurologic condition or brain injury

Symptoms

May include crying,‡ loss of interest or pleasure, sad mood, appetite changes, or

sleeping too much or too little§

Duration

Depression symptoms may last weeks to months

Episode Control

Crying, if present, may be voluntarily controlled or managed

Behavior vs Feelings

Outward expression matches feelings or intent

Accompanying Thoughts

Crying, if present, matches mood

PBA vs Depression

Please see enclosed Brief Summary of Important Facts. 7

* The Center for Neurologic Study-Lability Scale (CNS-LS) was developed by healthcare professionals to identify and measure symptoms suggestive of PBA. It does not diagnose PBA and is not intended to substitute for professional medical assessment and/or advice. Please consult with your doctor. The CNS-LS has been validated in MS and ALS patients.

Could you have PBA?Ask yourself, “Have I been experiencing sudden, frequent, and uncontrollable episodes of crying and/or laughing that don’t match how I feel?”

If the answer is yes, take the quiz on the next page and share it with your doctor.

A clinical diagnosis from a doctor is required to determine if a person has PBA.

Want to do it online?Visit NUEDEXTA.COM

PBA quizThe Center for Neurologic Study-Lability Scale (CNS-LS) was developed by healthcare professionals to help people identify PBA symptoms. It is not intended to substitute for professional medical assessment and/or advice. Please consult with your doctor.

1Choose your underlying neurologic

condition or brain injury

2For each item, use the scale to

write the number that applies to you during the past week

3Add your total score. Scores of 13 or higher

are more likely to suggest PBA*

4Tear out and show this

assessment to your doctor

Important Safety Information (continued)While taking NUEDEXTA, call your doctor right away:• If you feel faint or lose consciousness.

Please see enclosed Brief Summary of Important Facts. 8

Neurologic conditions that could lead to PBACheck any that apply

TBI (traumatic brain injury) Alzheimer’s disease/dementia Stroke MS (multiple sclerosis) ALS (Lou Gehrig’s disease) Parkinson’s disease Other neurologic condition

Assessment questions1 Applies never2 Applies rarely3 Applies occasionally

4 Applies frequently5 Applies most of

the time Enter score

1 There are times when I feel fine one minute, and then I’ll become tearful the next over something small or for no reason at all.

2 Others have told me that I seem to become amused very easily or that I seem to become amused about things that really aren’t funny.

3 I find myself crying very easily.

4 I find that even when I try to control my laughter, I am often unable to do so.

5 There are times when I won’t be thinking of anything happy or funny at all, but then I’ll suddenly be overcome by funny or happy thoughts.

6 I find that even when I try to control my crying, I am often unable to do so.

7 I find that I am easily overcome by laughter.

Total Score:

In studies, scores of 13 or higher were more likely to suggest PBA. However, this score does not diagnose PBA, and lower or higher scores can occur in persons with and without PBA. Only a doctor can determine if you have PBA.

“ My doctor prescribed NUEDEXTA, and I’ve stayed with it. That was something my doctor made sure I understood—that you need to keep taking it as prescribed for it to work like it should.”Hear more of Jim’s story at NUEDEXTA.com

Important Safety Information (continued)While taking NUEDEXTA, call your doctor right away:• If you experience lightheadedness, chills,

fever, nausea, or vomiting as these may be signs of an allergic reaction to NUEDEXTA. Hepatitis has been seen in patients taking quinidine, an ingredient in NUEDEXTA.

Actor portrayal

Please see enclosed Brief Summary of Important Facts. 9

Most common side effectsThe most common side effects of NUEDEXTA are:• diarrhea

• dizziness

• cough

• vomiting

• weakness

• swelling of feet and ankles

Each of these side effects was seen in less than 15% of patients taking NUEDEXTA in a clinical trial for PBA. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

Track your episodes

Make sure to track your PBA episodes after starting NUEDEXTA. You and your doctor should periodically reassess the need for treatment.

Important Safety Information (continued)

• Quinidine, an ingredient in NUEDEXTA, can cause a reduction in the number of platelets in your blood which can be severe and, if left untreated, can be fatal.

*Average reduction.† Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68:693-702.

Important Safety Information (continued)While taking NUEDEXTA, call your doctor right away:• If you have unexplained bleeding

or bruising.

Clinically proven to reduce PBA episodesIn a 12-week clinical trial, patients experienced an average of 44% fewer PBA episodes after the first week of taking NUEDEXTA.*

44%fewer PBA episodes

at Week 1

82%fewer PBA episodes

at Week 12

Average reduction in PBA episodes

% 51% of patients were completely free of PBA episodes during the final two weeks of the study. Your results may vary.

Results vs baseline. Patients taking placebo experienced 19% fewer PBA episodes at Week 1 and 45% fewer episodes at Week 12 and 29% were completely free of PBA episodes in the final 2 weeks of the 12-week study.†

Please see enclosed Brief Summary of Important Facts. 10

How to take NUEDEXTA Only your doctor can decide if NUEDEXTA is right for you. It’s important to take NUEDEXTA exactly as your doctor prescribes it.

Your first week on NUEDEXTA

WEEK 1For the first week, take 1 capsule each morning.

STEP UP your dose on DAY 8

   12 HRS   

DAY 8 On Day 8, increase your dose to 2 capsules per day—1 capsule every 12 hours. Be sure

to follow your doctor’s instructions.

Additional dosing information

NUEDEXTA may be taken with or without food.

Taking the prescribed dose helps keep the right amount of medicine in the body to help

control PBA episodes.

• If you miss a dose, do not take a double dose

• Take the next dose of NUEDEXTA in the amount your doctor prescribed at the usual time

• Do not take more than 2 capsules in a 24-hour period

Important Safety Information (continued)

• If you have muscle twitching, confusion, high blood pressure, fever, restlessness, sweating, or shivering, as these may be signs of a potential drug interaction called serotonin syndrome.

Important Safety Information (continued)While taking NUEDEXTA, call your doctor right away:• If you feel dizzy, since it may increase your

risk of falling.

Please see enclosed Brief Summary of Important Facts. 11

Important Safety Information (continued)

The most common side effects of NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, and swelling of feet and ankles. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

Savings and support

NUEDEXTA Co-Pay CalculatorInstantly find your out-of-pocket costs

for treating PBA with NUEDEXTA.

No insurance?If you have limited income and no health

insurance, the NUEDEXTA Patient Assistance Program may cover up to a 6-month supply.

NUEDEXTA Co-Pay Savings CardIf you have private insurance, this Co-Pay Savings Card can help you save on your

NUEDEXTA prescription and refills—over 76% of patients* with insurance pay $30 or less

per month. Restrictions apply.†

Visit NUEDEXTA.COMor call

1-855-4NUEDEX (468-3339)

* Symphony Health Dynamic Claims Data 2016.† Restrictions Apply. Those eligible for any state or federally funded prescription programs, including Medicare, Medicaid, Medigap, VA or DOD or TriCare are not eligible for this program.

Please see enclosed Brief Summary of Important Facts. 12

Important Safety Information (continued)

The most common side effects of NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, and swelling of feet and ankles. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

Visit NUEDEXTA.com

Take the quizThis short assessment (also found on pages 7–8 of this brochure) will help you and your doctor determine if you

or a loved one might have PBA.

Get tips for living with PBAOn the NUEDEXTA website, we’ve

compiled tips for managing and living with symptoms of PBA.

Share your storyTell us about your experience and help others like yourself.

Sign up for support

PBA PartnersPBA Partners provides you with simple, easy-to-follow tools to help you talk to your or a loved one’s doctor about PBA.

You’ll also learn how to start treatment and how to get the most out of your treatment.

When you sign up for PBA Partners at NUEDEXTA.com, you’ll receive:

• More information about PBA

• A PBA quiz to share with your doctor

• Tips for talking to your doctor about PBA

• Ways to save on NUEDEXTA

Please see enclosed Brief Summary of Important Facts. 13

Frequently asked questionsQ: What is NUEDEXTA approved for?A: NUEDEXTA is approved for the treatment of PseudoBulbar Affect (PBA). PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain injury. PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury. NUEDEXTA is only available by prescription.

Q: What should I ask my doctor?A: Let your doctor know how bothersome your crying and/or laughing episodes are. You’ll find tips for talking to your doctor at NUEDEXTA.com.

Q: How does NUEDEXTA work?A: Although the exact way in which NUEDEXTA works in people isn’t fully understood, it is thought to act inside the brain. NUEDEXTA is the only medicine specifically approved by the FDA to treat PBA.

Q: What are the most common side effects of NUEDEXTA?A: The most common side effects of NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, and swelling of feet and ankles. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

Q: How long does it take NUEDEXTA to start working?A: In a clinical study, patients experienced an average of 44% fewer PBA episodes after the first week of taking NUEDEXTA. Patients averaged 82% fewer episodes after 12 weeks.* Your results may vary. Results vs baseline. Patients taking placebo experienced 19% fewer PBA episodes at Week 1 and 45% fewer episodes at Week 12 and 29% were completely free of PBA episodes in the final 2 weeks of the 12-week study.†

Q: Do I continue to take my other medicines?A: Be sure to talk about this with your doctor. Your doctor may prescribe NUEDEXTA in addition to other medications you may be taking. However, NUEDEXTA and certain other medicines can interact, causing serious side effects. Be sure to tell your doctor about all medicines, supplements, and vitamins that you take before starting NUEDEXTA. Before starting a new medicine, remind your doctor if you are taking NUEDEXTA.

Important Safety Information (continued)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 800-FDA-1088.

*Average reduction.† Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68:693-702.

APPROVED SINCE

2010OVER 1,000,000PRESCRIPTIONS

Could your uncontrollable crying and/or laughing episodes that

don’t match how you feel be PseudoBulbar Affect (PBA)?

Talk to your doctor about PBA. Ask if NUEDEXTA is right for you.

©2017 Avanir Pharmaceuticals, Inc. All rights reserved. AVANIR and NUEDEXTA are trademarks or registered trademarks of Avanir Pharmaceuticals, Inc. in the United States and other countries. NUE-0609-WEB-0517

Questions?Visit NUEDEXTA.com or call 1-855-4NUEDEX (468-3339)

Please see enclosed Important Safety Information and Brief Summary of Important Facts.

IMPORTANT FACTS(Pronounced: new-DEX-tuh)

ABOUT NUEDEXTA• NUEDEXTA® is approved for the treatment of PseudoBulbar

Affect (PBA). PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain injury. PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury.

• NUEDEXTA is only available by prescription.

DO NOT TAKE NUEDEXTA IF YOU• Are taking other drugs that contain quinidine, quinine,

or mefloquine.• Have a history of allergic reactions or intolerance (including

hepatitis, low blood cell count, or lupus-like syndrome) to quinidine, quinine, or mefloquine.

• Have ever been allergic to dextromethorphan (commonly found in some cough medicines).

• Are taking, or have taken, drugs called monoamine oxidase inhibitors (MAOIs). MAOIs cannot be taken within 14 days before or after taking NUEDEXTA.

• Have had heart disease or have a family history of heart rhythm problems.

• Are taking drugs such as thioridazine and pimozide that interact with NUEDEXTA and cause changes in heart rhythm. If you have certain heart conditions or are taking certain medicines, your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA.

NUEDEXTA MAY CAUSE SERIOUS SIDE EFFECTS• Stop NUEDEXTA if these side effects occur: • Symptoms including lightheadedness, chills, fever, nausea,

or vomiting may be a sign of an allergic reaction, or thrombocytopenia which if left untreated can be fatal.

• Hepatitis has been seen in patients taking quinidine, an ingredient in NUEDEXTA.

• Abnormal heart rhythm. Stop NUEDEXTA and tell your doctor immediately as it may be a sign of Torsades de Pointes.

• In some cases NUEDEXTA can interact with antidepressants causing confusion, high blood pressure, fever, restlessness, sweating, and shivering. Tell your doctor if you experience any of these side effects.

• Tell your doctor if you’ve ever been diagnosed with myasthenia gravis. If so, NUEDEXTA may not be right for you.

POSSIBLE COMMON SIDE EFFECTS OF NUEDEXTAThe most common side effects in patients taking NUEDEXTA were diarrhea, dizziness, cough, vomiting, weakness and swelling of feet and ankles.• If you are unsteady on your feet or if you have fallen before,

be careful while taking NUEDEXTA to avoid falling.• This is not a complete list of side effects. • Tell your doctor if you have any side effect that bothers

you or does not go away.

TAKING NUEDEXTA ALONG WITH OTHER MEDICATIONS• Tell your doctor about all medicines, supplements,

and vitamins you take before starting NUEDEXTA. • NUEDEXTA may interact with other medications causing

potentially serious side-effects, and may affect the way NUEDEXTA or these other medicines work. Your doctor may adjust the dose of these medicines if used together with NUEDEXTA:

• Antidepressants. • Certain heart or blood pressure medications. Your doctor

may test your heart rhythm before you start NUEDEXTA. • Digoxin. • Alcohol. Limit alcohol intake while taking NUEDEXTA. • These are not the only medicines that may cause

problems when you take NUEDEXTA. • Before starting a new medicine, remind your doctor if you

are taking NUEDEXTA.

ADDITIONAL IMPORTANT INFORMATION• If your PBA symptoms do not improve or if they get

worse, contact your healthcare provider.• NUEDEXTA has not been studied in patients less than age 18

or in pregnant women. Tell your doctor if you may be pregnant.• Nursing mothers: Because many drugs are excreted in

human milk, discuss with your healthcare provider if you are nursing.

• Take NUEDEXTA exactly as your doctor prescribes it.• You and your healthcare provider should talk regularly

about whether you still need treatment with NUEDEXTA.• NUEDEXTA may be taken with or without food.• Keep NUEDEXTA and all medicines out of reach of children.• The need for continued treatment should be reassessed

periodically, as spontaneous improvement of PBA occurs in some patients.

NEED MORE INFORMATION?This information about NUEDEXTA is important but is not complete. To learn more:• Talk to your healthcare provider or pharmacist• Visit www.Nuedexta.com for FDA-approved Prescribing

Information or call 1-855-4NUEDEX (1-855-468-3339).

NEED PRESCRIPTION ASSISTANCE?• Call 1-855-4NUEDEX (1-855-468-3339) to speak

with a member of our support team for tips, tools and co-pay information.

Marketed by Avanir® Pharmaceuticals, Inc., Aliso Viejo, CA 92656

©2016 Avanir Pharmaceuticals, Inc. All rights reserved. AVANIR and NUEDEXTA are trademarks or registered trademarks of Avanir Pharmaceuticals, Inc. in the United States and other countries.NUE-0445-OTH-1116 Rev. Date Nov 2016