3 How NUEDEXTA can help

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1 For people with certain neurologic conditions or brain injuries Uncontrollable crying and/or laughing may be a sign of PseudoBulbar Affect (PBA) PBA is treatable. Learn more with your PBA Kit. You re about to learn about PBA and NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) 20 mg/10 mg capsules. NUEDEXTA is the first and only prescription medication specifically approved by the FDA to treat PseudoBulbar Affect (pronounced SOO-doh-BUHL-buhr AF-ekt). NUEDEXTA is not approved to treat symptoms other than PBA, the frequent, involuntary crying and/or laughing that may occur with certain neurologic conditions or brain injury. 3 steps that may help you identify and control your PBA outbursts 1 Understanding PBA PBA basics What PBA is and isn t PBA vs Depression 2 Do you have PBA? Start with a single question Take the quiz print and take to your doctor 3 How NUEDEXTA can help A proven treatment for PBA How to take NUEDEXTA Savings and support Helpful tools FAQs and questions for your doctor Important Safety Information There are risks associated with using NUEDEXTA. visit NUEDEXTA.com or click here.

2 1 Understanding PBA Who gets PBA PseudoBulbar Affect (PBA) is a neurologic condition that can occur when certain neurologic conditions or brain injuries damage areas of the brain involved in crying and/or laughing. This damage can disrupt brain signaling, similar to a short circuit, and trigger frequent episodes of crying and/or laughing that are often sudden and exaggerated or do not match what the person is feeling inside. Even if you ve never heard of PBA before your diagnosis, you re not alone. An estimated 2 million people in the US with neurologic conditions have PBA. It can affect men and women, old and young. Some conditions or injuries that can lead to PBA include * : Alzheimer s disease or other dementias Stroke Traumatic brain injury (TBI) Multiple sclerosis (MS) Parkinson s disease ALS (Amyotrophic Lateral Sclerosis)/ Lou Gehrig s Disease *This is not a complete list. Other neurologic conditions or brain injuries have also been associated with PBA. 2

3 The science of PBA PBA is not a new condition. For example, over 130 years ago Charles Darwin wrote that certain brain conditions tend to cause weeping. Over time, doctors have used different names to describe PBA and related conditions, such as: Emotional incontinence Pathological crying and laughing Emotional lability Involuntary Emotional Expression Disorder (IEED) Inappropriate or labile affect Motor cortex Frontal and temporal cortex Network disruption Brainstem Cerebellum When the brain s circuitry is intact and working normally, our thoughts and emotions merge in a relay of information to the brainstem, or bulb (the bulbar part of PseudoBulbar Affect). This enables the appropriate expression of emotion, such as crying and laughing, through the muscles of the face and other body areas that demonstrate emotional expression. Involuntary crying and/or laughing Adapted from Miller, Damage from brain injury or certain neurologic conditions disrupts the normal control of crying and/or laughing. Neurologists believe brain injuries and certain neurologic conditions may cause damage that disrupts some of these signals, including ones that tell your body when or how much to cry or laugh. In some cases, this can be a sign of PBA. 3

4 Recognizing PBA What PBA is not People with PBA experience frequent, uncontrollable outbursts of crying and/or laughing that may not match how they re feeling inside. These outbursts are often: Exaggerated They may be more intense or last longer than expected, such as crying very easily or for a long time after seeing a touching movie or laughing at a joke long after others have stopped. Mismatched They may not fit the situation or a person s actual feelings, such as laughing at a funeral or crying when a friend shares good news. While PBA stems from a neurologic condition or brain injury, it s important to recognize PBA as a separate condition. PBA is NOT......depression PBA and depression are separate conditions. People may have both PBA and depression. Both are treatable and should be diagnosed....just a part of your neurologic condition PBA is a distinct condition that can occur as a result of a neurologic condition....a sign that you are going crazy Many people with PBA are relieved to learn they are not alone and their PBA is treatable. 4

5 Key differences: PBA vs Depression PBA * Underlying condition Only occurs in people with brain injuries or neurologic conditions, such as Alzheimer s and dementia, stroke, MS, Parkinson s, and ALS Depression * Underlying condition? May or may not have underlying neurologic condition Symptoms Crying, laughing, or both Symptoms May include crying, loss of interest or pleasure, sad mood, weight changes, or sleeping too much or too little Duration Brief crying and/or laughing episodes lasting seconds to minutes Duration Depression symptoms may last weeks to months Episode control Crying and/or laughing episodes are uncontrollable Episode control Crying, if present, may be controlled or managed Behavior vs feelings Crying and/or laughing are exaggerated/do not match mood Behavior vs feelings Outward behavior matches feelings or intent Accompanying thoughts Outbursts may not be related to a happy or depressed mood Accompanying thoughts Crying, if present, matches mood * Formal diagnosis of PBA or depression can only be made by a qualified healthcare professional. 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. This is not a complete list. Other neurologic conditions may be associated with PBA. 5 Tearfulness/crying is not a diagnostic hallmark for depression diagnosis. Diagnosis can only be made by a healthcare professional. These are not all the symptoms of depression.

6 2 Do you have PBA? Start here First, ask yourself the same question a doctor might ask you: Have I ever experienced uncontrollable episodes of crying and/or laughing that were exaggerated or even contrary to how I felt at the time? PBA quiz The Center for Neurologic Study-Lability Scale (CNS-LS) was developed by healthcare professionals to help people measure and screen for laughing and crying episodes that could be symptoms of PBA. It is not intended to substitute for professional medical assessment and/or advice. Please consult with your doctor. 1 Indicate your neurologic condition or brain injury A clinical diagnosis is required to determine if a person has PBA. If the answer is yes, take the quiz on the next page and share it with your doctor. Take the quiz 2 3 For each item, use the scale to write the number that applies to you during the past week Add your total score. Scores of 13 or higher are more likely to suggest PBA* 4 Print and show this assessment to your doctor 6 * 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. Your doctor will still need to determine if you have PBA.

7 Neurologic conditions that could lead to PBA Check any that apply Alzheimer s Disease or Dementia Stroke Traumatic Brain Injury (TBI) Multiple Sclerosis (MS) Parkinson s Disease Lou Gehrig s Disease (ALS) Other Neurologic Condition I feel better knowing there are other people going through this and that we can actually get some help. - Shevoney D. Person living with PBA Assessment questions 1 Applies never 2 Applies rarely 3 Applies occasionally 4 Applies frequently 5 Applies most of the time 1 2 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. 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 I find that even when I try to control my laughter, I am often unable to do so. 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. I find that even when I try to control my crying, I am often unable to do so. 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. Your doctor will still need to determine if you have PBA. 7

8 3 How NUEDEXTA can help NUEDEXTA is the first and only prescription medication specifically approved to treat PBA frequent, uncontrollable crying and/or laughing. PBA occurs secondary to a variety of otherwise unrelated neurologic conditions or brain injury. People with PBA experience sudden, frequent, and uncontrollable episodes of crying and/or laughing. These episodes may be exaggerated or may not reflect how they are feeling inside. PBA is a specific condition, distinct from other emotion-related issues that may occur in patients with neurologic conditions or brain injury. NUEDEXTA is not approved to treat depression. PBA and depression are separate conditions. Both are treatable and should be diagnosed. NUEDEXTA contains two components: dextromethorphan and quinidine, medicines that have been used separately to treat conditions other than PBA but that work uniquely together to treat PBA. Important Safety Information Before 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. 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. 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. If you have myasthenia gravis. NUEDEXTA is thought to act on certain connection points inside the brain. With NUEDEXTA, PBA episodes of unwanted crying and/or laughing can be reduced. In fact, in a 12-week study, 51% of patients were completely free of PBA episodes in the final two weeks of the study. Your results may vary. 8

9 NUEDEXTA is clinically proven to reduce PBA episodes In a clinical trial, patients experienced an average of 44% fewer PBA episodes after the first week of taking NUEDEXTA. What s more, they averaged 82% fewer episodes after 12 weeks and 51% of patients were completely free of PBA episodes during the final two weeks of the study.* Whether PBA episodes occurred after the study is unknown. Your results may vary. Week 1 Week 12 44% fewer episodes Average reduction 82% fewer episodes Tell your doctor if your PBA episodes continue or get worse. Your doctor should periodically reassess the need for treatment as PBA symptoms may sometimes improve on their own. Important Safety Information While taking NUEDEXTA, call your doctor right away: If you feel faint or lose consciousness. 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. If you have unexplained bleeding or bruising. 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. If you feel dizzy, since it may increase your risk of falling. 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. *Results vs baseline from a 12-week clinical study that evaluated safety and efficacy of NUEDEXTA for the treatment of PBA in ALS and MS patients. Patients on placebo experienced a 19% reduction in PBA episodes at Week 1 and a 45% reduction in PBA episodes at Week 12 compared to baseline. 9

10 How to take NUEDEXTA Only your doctor can decide if NUEDEXTA is right for you. Take NUEDEXTA exactly as your doctor prescribes it. Days 1 7 For the first week, take 1 capsule each morning. Beginning Day 8 On Day 8, increase your dose to 2 capsules per day 1 capsule every 12 hours. 12 hours NUEDEXTA may be taken with or without food. Continuing on NUEDEXTA It s important to keep taking your treatment as your doctor prescribes. Your doctor may want to evaluate from time to time whether you need to keep taking NUEDEXTA. In some cases, PBA symptoms improve on their own over time. Important Safety Information 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. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 800-FDA If you miss a dose, do not take a double dose. Take your next dose of NUEDEXTA in the prescribed amount at the usual time. Do not take more than 2 capsules in a 24-hour period. Make sure that 12 hours pass between doses. 10

11 NUEDEXTA savings and support NUEDEXTA Co-pay Calculator Instantly find your monthly cost for NUEDEXTA Learn about options to help reduce your prescription costs 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 Card If you have private insurance, a co-pay savings card allows you to pay no more than $30 for your NUEDEXTA prescription and refills. Restrictions apply. Pay No More Than $30 * For your next NUEDEXTA prescription and refills. Restrictions apply. RxBIN: RxPCN: Loyalty RxGRP: ISSUER: (80840) ID: (see reverse) *Benefit cap applies regardless of copay amount. Other restrictions apply. 11

12 Helpful tools at NUEDEXTA.com Take the quiz This short assessment (also found on page 7 of this PDF) will help you and your doctor determine if you might have PBA. My crying is more under control now...with NUEDEXTA. Track your progress Download a convenient weekly chart to help you monitor the effects of NUEDEXTA on your PBA episodes. - Bernadetta B. Person living with PBA Hear from others Hear from others who know what you re going through. On our website, you ll find personal stories and videos of PBA patients and their caregivers. 12

13 Frequently asked questions about NUEDEXTA Ask your doctor How does NUEDEXTA treat PBA? Although the exact way in which NUEDEXTA works in people is unknown, it is thought to act on certain signaling areas inside the brain and is specifically approved to treat PBA. How long does it take NUEDEXTA to start working? In a clinical trial, some patients experienced fewer PBA episodes after the first week of taking NUEDEXTA. Your individual results may vary. Before considering any medication, you should talk to your doctor to make sure it s right for you. Here are some things to bring up at your next visit: Do you think I have PBA? How is PBA different from depression? Can NUEDEXTA help me control my PBA outbursts? What can I expect from taking NUEDEXTA? Can I safely continue to take my other medications along with NUEDEXTA? Do I continue to take my other medicines? Your doctor may prescribe NUEDEXTA in addition to other medications you may be taking. 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. 13

14 Important Safety Information NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) 20 mg/10 mg capsules are approved for the treatment of PseudoBulbar Affect (PBA). PBA is a medical condition that causes sudden, frequent and uncontrollable outbursts of crying and/or laughing in people living with certain neurologic conditions or brain injury. Before you take NUEDEXTA, tell your doctor: If you are taking monoamine oxidase inhibitors (MAOIs), quinidine, or quinidinerelated 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. 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. 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. If you have myasthenia gravis. While taking NUEDEXTA, call your doctor right away: If you feel faint or lose consciousness. 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. If you have unexplained bleeding or bruising. 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. If you feel dizzy, since it may increase your risk of falling. 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. 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. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 800-FDA For Full Prescribing Information, 14

15 Start taking control of your PBA episodes of crying and/or laughing Ask your doctor about NUEDEXTA for the treatment of PseudoBulbar Affect (PBA). Questions? Call NUEDEX ( ) or visit NUEDEXTA.com Avanir Pharmaceuticals, Inc. and Otsuka America Pharmaceutical, Inc., All Rights Reserved. NUE-0260-OTH-0516