PBA is treatable. Learn more inside.

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1 For people with certain neurologic conditions or brain injury Sudden, frequent, and uncontrollable crying and/or laughing that doesn t match how they feel may be a sign of PseudoBulbar Affect (PBA) PBA is treatable. Learn more inside. Actor portrayal 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.

2 Here s what you need to know about PBA crying and/or laughing episodes. 1 Understanding PBA PBA basics 3 4 What PBA is and isn t Could it be PBA? What to ask 7 Take the quiz How NUEDEXTA can help Treating PBA with NUEDEXTA 9 How to take NUEDEXTA 10 Savings and support 11 Helpful tools 12 FAQs 13 NUEDEXTA was approved by the FDA in 2010 as the first and only prescription medication to treat PseudoBulbar Affect (PBA). PseudoBulbar Affect pronunciation: SUE-doh-BUHL-buhr AF-ekt 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. 2

3 Understanding PBA PseudoBulbar 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. Important Safety Information 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. 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 * Work SS, Colamonico JA, Bradley WG, Kaye RE. Pseudobulbar affect: an under-recognized and under-treated neurological disorder. Adv Ther. 2011;28: This is not a complete list. Other neurologic conditions have also been associated with PBA. Please see enclosed Brief Summary of Important Facts. 3

4 The science of PBA Think 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 The brain s process Feelings Signals Crying or laughing match how you feel 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 Feelings Signal disruption PBA Crying or laughing is exaggerated or doesn t match how you feel 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. 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. Please see enclosed Brief Summary of Important Facts. 4

5 Recognizing PBA People 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: Exaggerated They 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. 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. 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 condition PBA 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. Mismatched They 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. Before you take NUEDEXTA, tell your doctor: If you have myasthenia gravis. Please see enclosed Brief Summary of Important Facts. 5

6 PBA vs Depression 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 Depression* Underlying Condition May or may not have an underlying neurologic condition or brain injury Symptoms Sudden, frequent crying and/or laughing Symptoms May include crying, loss of interest or pleasure, sad mood, appetite changes, or sleeping too much or too little Duration Duration Brief crying and/or laughing episodes last seconds to minutes Depression symptoms may last weeks to months Episode Control Episode Control Crying and/or laughing episodes are uncontrollable Crying, if present, may be voluntarily controlled or managed Behavior vs Feelings Behavior vs Feelings Crying and/or laughing are exaggerated or do not match how you feel Outward expression matches feelings or intent Accompanying Thoughts Accompanying Thoughts Episodes may not be related to a happy or depressed mood Crying, if present, matches mood * 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. 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. Please see enclosed Brief Summary of Important Facts. 6

7 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 quiz The 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. 1 Choose your underlying neurologic condition or brain injury 2 For each item, use the scale to write the number that applies to you during the past week 3 Add your total score. Scores of 13 or higher are more likely to suggest PBA* 4 Tear out and show this assessment to your doctor While taking NUEDEXTA, call your doctor right away: If you feel faint or lose consciousness. * 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. Please see enclosed Brief Summary of Important Facts. 7

8 Neurologic conditions that could lead to PBA Check 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 Actor portrayal Assessment questions 1 Applies never 2 Applies rarely 3 Applies occasionally 4 Applies frequently 5 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 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. 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 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. 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. Please see enclosed Brief Summary of Important Facts. 8

9 Clinically proven to reduce PBA episodes In 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. Most common side effects The most common side effects of NUEDEXTA are: diarrhea vomiting dizziness weakness cough 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. 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. While taking NUEDEXTA, call your doctor right away: 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. *Average reduction. Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68: Please see enclosed Brief Summary of Important Facts. 9

10 How to take NUEDEXTA Additional dosing information 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 NUEDEXTA may be taken with or without food. WEEK 1 For 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. 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 While taking NUEDEXTA, call your doctor right away: 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. Please see enclosed Brief Summary of Important Facts. 10

11 Savings and support NUEDEXTA Co-Pay Calculator Instantly 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 Card If 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.COM or call NUEDEX ( ) 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. * Symphony Health Dynamic Claims Data 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. 11

12 Visit NUEDEXTA.com Sign up for support Take the quiz This 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. PBA Partners PBA 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: Get tips for living with PBA On the NUEDEXTA website, we ve compiled tips for managing and living with symptoms of PBA. 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 Share your story Tell us about your experience and help others like yourself. 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. Please see enclosed Brief Summary of Important Facts. 12

13 Frequently asked questions Q: 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. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 800-FDA *Average reduction. Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68: Please see enclosed Brief Summary of Important Facts. 13

14 APPROVED SINCE 2010 OVER 1,000,000 PRESCRIPTIONS 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. Questions? Visit NUEDEXTA.com or call NUEDEX ( ) Please see enclosed Important Safety Information and Brief Summary of Important Facts 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

15 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 NUEDEXTA The 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 for FDA-approved Prescribing Information or call NUEDEX ( ). NEED PRESCRIPTION ASSISTANCE? Call NUEDEX ( ) to speak with a member of our support team for tips, tools and co-pay information. Marketed by Avanir Pharmaceuticals, Inc., Aliso Viejo, CA 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