Helping a friend or loved one manage bipolar depression.

Transcription

1 each month for up to 12 prescriptions Helping a friend or loved one manage bipolar depression. Please see Important Safety Information, including Boxed Warnings, on pages 18-21, and #1 Prescribed Branded Medication Approved for Bipolar Depression based on total antipsychotics prescription data from QuintilesIMS as of December * 15 Pay as little as a $ Copay Making copays more affordable. See page 10 to learn how you may save on a LATUDA prescription. Exclusions may apply. Important Safety Information and Indications for LATUDA INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA- RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death compared to patients receiving placebo (sugar pill). LATUDA is not approved for the treatment of patients with dementia-related psychosis. Antidepressant medicines may increase suicidal thoughts or behaviors in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. LATUDA is not approved for use in pediatric patients with depression.

2 Ask your doctor about Latuda (lurasidone HCl) for bipolar depression LATUDA is a once-a-day prescription medicine FDA-approved to treat bipolar depression in adults. LATUDA has been shown to be effective on its own or with lithium or valproate. Treatment, such as LATUDA, may help your friend or loved one manage his or her symptoms. Understanding bipolar depression Bipolar depression refers to the depressive phase of bipolar disorder. More than 4 in every 100 Americans will be diagnosed with bipolar disorder at some time in their lives. Most people with bipolar disorder eventually experience one or more depressive episodes, and these depressive symptoms are often more prominent and take longer to manage. Symptoms of bipolar depression People with bipolar depression may have symptoms such as: No interest in activities they once enjoyed Loss of energy Difficulty sleeping either sleeping too much or not at all Changes in appetite eating too much or too little Difficulty concentrating, remembering, or making decisions Thoughts of death or suicide* * If your friend or loved one talks about suicide, do not leave the person alone. Call their healthcare provider right away or bring them to the emergency room. The National Suicide Prevention Lifeline is also open 24 hours a day at Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death compared to patients receiving placebo (sugar pill). LATUDA is not approved for the treatment of patients with dementia-related psychosis. Antidepressant medicines may increase suicidal thoughts or behaviors in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. LATUDA is not approved for use in pediatric patients with depression. 2 3

3 Bipolar depression is different The Mood Disorder Questionnaire for Caregivers There are many types of depression. In fact, depressive symptoms such as sadness, emptiness, and hopelessness are the same across most forms of depression. A person is diagnosed with bipolar depression associated with bipolar I disorder when there is also the presence of a manic episode, or mania. Symptoms of a manic episode may include Feelings of euphoria, abnormal excitement, or elevated mood Talking very rapidly or excessively Needing less sleep than normal, yet still having plenty of energy Feeling agitated, irritable, hyper, or easily distracted Engaging in risky behavior such as lavish spending, impulsive sexual encounters, or ill-advised business decisions Bipolar depression may be difficult to diagnose If a person with bipolar disorder sees a doctor while depressed, a previous experience of mania may be overlooked or forgotten, leading to a misdiagnosis of major depressive disorder. That s why it s important for your friend or loved one to mention any manic episodes, no matter how far in the past they occurred. Family history is also important, as it is one of the strongest and most consistent risk factors for bipolar disorder. If someone else in your friend or loved one s family has bipolar disorder or another mental illness, urge them to mention it to their doctor. Only your friend or loved one s doctor can diagnose bipolar depression. Neuroleptic malignant syndrome (NMS) is a rare but very serious condition that can happen in people who take antipsychotic medicines, including LATUDA. NMS can cause death and must be treated in a hospital. Call your health care provider right away if you become severely ill and have some or all of these symptoms: high fever, excessive sweating, rigid muscles, confusion, or changes in your breathing, heartbeat or blood pressure. Tardive dyskinesia (TD) is a serious and sometimes permanent side effect reported with LATUDA and similar medicines. Tell your doctor about any movements you cannot control in your face, tongue, or other body parts, as they may be signs of TD. TD may not go away, even if you stop taking LATUDA. TD may also start after you stop taking LATUDA. Answer each of the following questions about your friend or loved one to the best of your ability, then talk with a healthcare provider 1. Has there ever been a period of time when your friend or loved one was not their usual self and he or she seemed to feel so good or so hyper that other people thought they were not their normal self, or they were so hyper that they got into trouble? he or she was so irritable that they shouted at people or started fights or arguments? he or she appeared to feel much more self-confident than usual? he or she got much less sleep than usual and didn t appear to really miss it? he or she was much more talkative and/or spoke much faster than usual? he or she has ever expressed that their thoughts raced in their head and/or they couldn t slow their mind down? he or she was so easily distracted by things around them that they had trouble concentrating or staying on track? he or she had much more energy than usual? he or she was much more active and/or did many more things than usual? he or she was much more social or outgoing than usual for example, telephoning friends in the middle of the night? he or she was much more interested in sex than usual? he or she did things that were unusual for them or that you or other people might have thought were excessive, foolish, or risky? spending money got them or their family into trouble? Yes No Continued on page

4 The Mood Disorder Questionnaire for Caregivers Get and stay involved in medical decisions Continued from page 6 2. If you checked YES to more than one of the questions on the reverse page, has your friend or loved one experienced several of these during the same period of time? 7 Yes No 3. How much of a problem did any of these cause your friend or loved one (like being unable to work; having family, money, or legal problems; and/or getting into arguments or fights)? No problem Minor problem Moderate problem Serious problem This instrument is designed for screening purposes only and is not to be used as a diagnostic tool. For consultation with your friend s or loved one s healthcare provider only by Robert M.A. Hirschfeld, MD. Reprinted with permission. Jones & Bartlett Learning, LLC NOT FOR SALE OR DISTRIBUTION Along with your friend or loved one and his or her doctor, you are part of the support team. If helping to make important medical decisions is part of your responsibility, your friend or loved one may need to sign a release so the doctor can share medical information with you. Let the doctor know about any side effects or changes in behavior Since you may notice things that your friend or loved one may not like changes in mood or behavior stay alert to changes and have an open discussion with your friend or loved one and their doctor. Sunovion Answers support for Latuda (lurasidone HCl) is for you too Sunovion Answers for LATUDA is designed to support your friend or loved one s treatment. Your role in helping them with their treatment could make a difference in their success too. That s why Sunovion Answers is also focused on helping you. Visit to discover all the resources available to you and your friend or loved one. 8 Here s the type of support you ll find on LATUDA Savings Card Access to Reimbursement Specialist Sign up for communications with helpful information for you and your friend or loved one Doctor Discussion Guide The Daily Mood Monitor Watch real patient stories about living with bipolar depression and taking LATUDA One number to call for all questions To find out more about LATUDA, call Sunovion Answers at LATUDA ( ). Available anytime between 8 AM 12 midnight (EST) Remember, you can be your friend or loved one s best advocate. If the doctor has diagnosed them with bipolar depression, ask if LATUDA may be the right treatment for them. Increases in blood sugar can happen in some people who take LATUDA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your health care provider should check your blood sugar before you start LATUDA and during therapy. Call your health care provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking LATUDA: feel very thirsty, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick to your stomach, feel confused, or your breath smells fruity. 9

5 Help your friend or loved one stay on his or her medication Latuda (lurasidone HCl) is taken once a day with food of at least 350 calories. Taking LATUDA with food can help the body absorb the medicine. Everyone responds to medication differently. Many medications prescribed for depression work gradually, so it may take some time to notice improvements in your friend or loved one. For this reason, it s important for your friend or loved one to take LATUDA exactly as prescribed, and to not stop taking LATUDA without speaking to his or her healthcare provider. You should encourage your friend or loved one to visit a healthcare provider regularly. Daily reminders, gentle encouragement, and possibly keeping a journal or calendar can really help your friend or loved one stay on track. Look for the Daily Mood Monitor on With LATUDA, your friend or loved one may pay as little as a $15* copay a month If eligible, the LATUDA Savings Card may lower your friend or loved one s copay to as little as a $15 copay per month for up to 12 months saving up to $125* each fill. Simply show the LATUDA Savings Card at the pharmacy when filling or refilling the prescription. * Check eligibility by visiting or call LATUDA ( ). To be eligible, you must be 18 or older, with a valid prescription for LATUDA, and make a cash payment or be commercially insured. Exclusions may apply. 10 Increases in triglycerides and LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported with LATUDA. You may not have any symptoms, so your health care provider may decide to check your cholesterol and triglycerides during your treatment with LATUDA. 11

6 Be prepared to get help if your friend or loved one needs it Supporting a friend or loved one with bipolar depression Treatment, such as Latuda (lurasidone HCl), may help your friend or loved one manage symptoms, but living with someone with bipolar disorder can still be a challenge. As a partner in your friend or loved one s care, you play a vital role in helping your friend or loved one manage bipolar depression. You are someone he or she can trust, rely on for support, and help make important treatment decisions. Keep important details close Supporting your friend or loved one by being ready in case of an emergency. You should have easy access to the following contact details and information. Your friend or loved one s healthcare provider and pharmacy Their medications and dosage Their insurance Bipolar depression hotline and support groups Tell your doctor if you experience any of these: feeling dizzy or light-headed upon standing decreases in white blood cells (which can be fatal) trouble swallowing 12 13

7 Caring for yourself is just as important When a friend or loved one has bipolar depression, it can impact you too. You may need to cope with a variety of symptoms, including mood swings, drinking too much, or strains on relationships. It is important to take care of yourself. Here are some things that can help: Exercise and eat a healthy diet Get enough rest Prioritize to avoid feeling overwhelmed Take a break even an afternoon will help Stay connected and get support joining a support group can help your own mental health Trust yourself. Believing that you can handle the stress of being a caregiver will help you do just that 14 To ease stress, establish a future plan for your friend or loved one s care should you no longer be able to act as caregiver Share the responsibility, if possible. Shifting the responsibility from one person to the entire family or support team can help encourage a sense of team involvement, and a we re in this together attitude LATUDA and medicines like it may raise the level of prolactin. Tell your health care provider if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence. 15

8 Questions you may want to ask your friend or loved one s doctor about Latuda (lurasidone HCl) Maybe your friend or loved one is newly diagnosed or maybe he or she is considering asking their healthcare provider if LATUDA is right for them. Either way, this guide can help you make a decision together: What are the benefits of LATUDA? What are the risks of LATUDA? How safe is it? Can you tell me about the clinical study data on weight? What if my friend or loved one is pregnant or planning to become pregnant? What side effects should I look for in my friend or loved one? My friend or loved one is currently taking lithium or valproate. Could LATUDA be right for him or her in addition to their current medication(s)? Other things I d like to know from my friend or loved one s doctor: 16 Tell your health care provider if you have a seizure disorder, have had seizures in the past, or have conditions that increase your risk for seizures. 17

9 Important Safety Information and Indications for Latuda (lurasidone HCl) INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death compared to patients receiving placebo (sugar pill). LATUDA is not approved for the treatment of patients with dementia-related psychosis. Antidepressant medicines may increase suicidal thoughts or behaviors in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. LATUDA is not approved for use in pediatric patients with depression. LATUDA can cause serious side effects, including stroke that can lead to death, which can happen in elderly people with dementia who take medicines like LATUDA. Neuroleptic malignant syndrome (NMS) is a rare but very serious condition that can happen in people who take antipsychotic medicines, including LATUDA. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you become severely ill and have some or all of these symptoms: high fever, excessive sweating, rigid muscles, confusion, or changes in your breathing, heartbeat, or blood pressure. Tardive dyskinesia (TD) is a serious and sometimes permanent side effect reported with LATUDA and similar medicines. Tell your doctor about any movements you cannot control in your face, tongue, or other body parts, as they may be signs of TD. TD may not go away, even if you stop taking LATUDA. TD may also start after you stop taking LATUDA. Increases in blood sugar can happen in some people who take LATUDA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start LATUDA and during therapy. Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking LATUDA: feel very thirsty, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick to your stomach, feel confused, or your breath smells fruity. Increases in triglycerides and LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported with LATUDA. You may not have any symptoms, so your healthcare provider may decide to check your cholesterol and triglycerides during your treatment with LATUDA. Some patients may gain weight while taking LATUDA. Your doctor should check your weight regularly. Tell your doctor if you experience any of these: feeling dizzy or light-headed upon standing, decreases in white blood cells (which can be fatal), trouble swallowing. LATUDA and medicines like it may raise the level of prolactin. Tell your healthcare provider if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence. Tell your healthcare provider if you have a seizure disorder, have had seizures in the past, or have conditions that increase your risk for seizures

10 Tell your health care provider if you experience prolonged, abnormal muscle spasms or contractions, which may be a sign of a condition called dystonia. LATUDA can affect your judgment, thinking, and motor skills. You should not drive or operate hazardous machinery until you know how LATUDA affects you. LATUDA may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm. Avoid eating grapefruit or drinking grapefruit juice while you take LATUDA since these can affect the amount of LATUDA in the blood. Tell your health care provider about all prescription and over-the-counter medicines you are taking or plan to take, since there are some risks for drug interactions with LATUDA. Tell your health care provider if you are allergic to any of the ingredients of LATUDA or take certain medications called CYP3A4 inhibitors or inducers. Ask your health care provider if you are not sure if you are taking any of these medications. Avoid drinking alcohol while taking LATUDA. Tell your health care provider if you are pregnant or if you are planning to get pregnant. Avoid breastfeeding while taking LATUDA. The most common side effects of LATUDA include sleepiness or drowsiness; restlessness or feeling like you need to move around (akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; runny nose/nasal inflammation, and nausea. These are not all the possible side effects of LATUDA. For more information, ask your health care provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call l-800-fda INDICATIONS LATUDA is used to treat patients with: Depressive episodes in bipolar I disorder (bipolar depression) when used alone or with lithium or valproate in adults Schizophrenia in adults and adolescents 13 to 17 years of age PLEASE SEE ENCLOSED MEDICATION GUIDE

11 Making copays more affordable. See page 10 to learn how you may save on a LATUDA prescription. Exclusions may apply. LATUDA, SUNOVION, and are registered trademarks of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd Sunovion Pharmaceuticals Inc. All rights reserved. 8/17 LAT813-17