Bipolar I Support & Resources - VRAYLAR® (cariprazine) Skip to Main Content For adults in the treatment of bipolar I depression and for the short-term treatment of manic or mixed episodes of bipolar I disorder. For adults in the treatment of bipolar I depression and for the short-term treatment of manic or mixed episodes of bipolar I disorder. For adults in the treatment of bipolar I depression and for the short-term treatment of manic or mixed episodes of bipolar I disorder. SELECT CONDITION Major Depressive Disorder Bipolar I Disorder Other Condition Important Safety Information Prescribing Information Medication Guide Cost & Savings Healthcare Professional Site Sign up for support See savings* Why VRAYLAR? Is VRAYLAR right for you? How does VRAYLAR work? Who is VRAYLAR for? How do I take VRAYLAR? What side effects are possible? Bipolar I basics What is bipolar I disorder? What are the symptoms? What can trigger episodes? How is it diagnosed? How is it treated? Support & resources Track your mood & symptoms Watch real bipolar I stories Tips from a healthcare provider Sign up for helpful resources Find a support group Tools for friends and family FAQs Resources for starting VRAYLAR Save on VRAYLAR Connect with a healthcare provider Sign up for support social fb insta youtube Healthcare Professional site En Español VRAYLAR Support & Resources Helpful tools for your journey VRAYLAR effectively treats bipolar I depression and acute manic or mixed episodes of bipolar I in adults, providing full-spectrum relief for all bipolar I symptoms. But controlling the mood swings of bipolar I disorder is about more than medication. Resources that may help optimize your treatment include: Doctor discussion guide Personalize your guide Patient brochure Download brochure Find a healthcare provider Search near you Have you taken any medication(s) for your bipolar I? Select an answer below to learn how VRAYLAR may work to treat your bipolar I. Yes, I have taken multiple medications to help treat my bipolar I. Yes, I have taken one medication to treat my bipolar I. No, but I would like to learn more about managing bipolar I. Yes, I have taken multiple medications to help treat my bipolar I. Can VRAYLAR treat the highs AND lows? There are many ways to manage your bipolar I. Learn how VRAYLAR can help treat depressive, acute manic and acute mixed episodes of bipolar I. Get to know VRAYLAR Yes, I have taken one medication to treat my bipolar I. How can I treat the highs AND lows? You may experience bipolar I depressive, acute mixed and acute manic episodes. It is important to treat all parts of bipolar I. Learn how VRAYLAR can help by treating both the highs and lows. See VRAYLAR in action No, but I would like to learn more about managing bipolar I. How can I learn more about managing the highs and lows? Learn more about treating the highs and lows and hear real stories from people living with bipolar I. Get more information Reset Bipolar I stories of strength Listen to real people with bipolar I disorder share their experiences. Hear more about the signs and symptoms they face during their journey. The people featured in these videos are sharing their individual experiences with bipolar I . Individual experiences with the condition and treatment will vary. Not all of those featured are currently taking VRAYLAR. These videos are brought to you by AbbVie. Talk to your healthcare provider to see if VRAYLAR may be right for you. A patient’s experience with VRAYLAR A patient’s experience with VRAYLAR Bipolar I diagnosis stories Bipolar I diagnosis stories Living with bipolar I Living with bipolar I Many patients, many paths Many patients, many paths Tips from a healthcare provider Tips from a healthcare provider Alec's bipolar I toolbox (part 1) Watch Now View transcript Alec shares his treatment journey and the tools that help him manage his bipolar I . Watch Now Alec's bipolar I toolbox (part 2) Watch Now Alec's bipolar I toolbox (part 3) Watch Now Alec's bipolar I toolbox (part 2) Watch Now Alec's bipolar I toolbox (part 3) Watch Now View Transcript Jacqueline’s relief once she got her bipolar I diagnosis Jacqueline, a mom, talks through her struggle with the highs and lows of bipolar I . Watch Now Alec's family helps him manage bipolar I Watch Now Christine grew up undiagnosed Watch Now The journey to bipolar I diagnosis Watch Now Jon's journey through misdiagnosis Watch Now View Transcript Dailyn, a spoken word poet, addresses stigma Dailyn shares her bipolar I experience with a poem. Watch Now Tips about living with bipolar I Watch Now Patient advice for others with bipolar I Watch Now Heidi shares how bipolar I is part of who she is Watch Now Bex opens up about bipolar I and therapy Watch Now Gabe talks about how his mood changes with bipolar I Watch Now View Transcript Understanding possible triggers of bipolar I Real patients discuss the many possible triggers of bipolar I . Watch Now Why routines are important Watch Now Why finding support with your bipolar I journey is important Watch Now What bipolar I and mania symptoms may feel like Watch Now Why is friend and family support so important when living with bipolar I disorder? Watch Now View Transcript Strategies for everyday living Get practical coping strategies for living with bipolar I . Managing your bipolar I can be overwhelming at times, but gaining knowledge and support can help you become more comfortable along the way. Listen to psychiatrist Dr. David Scheiderer share tips on maximizing your healthcare provider visits, telemedicine, coping strategies, and more. Dr. Scheiderer is a healthcare provider and was compensated for his appearance. This content does not constitute medical advice or establish a patient-physician relationship. Please talk to your healthcare provider about your specific treatment needs. Watch Now Support systems for bipolar I Watch Now Setting simple goals Watch Now Being a partner in your care Watch Now Get the most out of your bipolar I virtual visit Find balance with My Mood Matters My Mood Matters provides support and resources to help you take control. Sign up for My Mood Matters to get tips, tools, and resources sent right to your inbox. And as a thank you for enrolling, you’ll receive our mobile meditation guide, “Mind Over Mood Swing.” Sign up Peer support groups for bipolar I Feeling isolated? Know that you are not alone. Connecting with other people who have bipolar I disorder may help you stay on track with your treatment journey and learn new ways to manage your condition. Find a support group Watch Now Friends and family support for bipolar I View transcript Support for friends and family When someone has bipolar I disorder, it affects not only them but the people in their lives. Finding a support network can be helpful for your loved one’s journey. But supporting your friend or family member can demand a lot of empathy and energy from you. The National Alliance on Mental Illness provides information and support for family and friends that you may find helpful. Important questions for caregivers to ask Tip: Take a screenshot of this list to discuss with a healthcare provider. How do I help if my friend or loved one has a manic or mixed episode? What are some ways I can support my friend or loved one? How do I avoid falling into “compassion fatigue” or burning out? How do I help if my friend or loved one has a depressive episode? Where can I get more help and information on being a good caregiver? What are some ways I can take care of myself, too? Ready to share your VRAYLAR story? Have you taken VRAYLAR and want to tell your story? Just call 347-305-1330 347-305-1330 or email patientengagement@healthcentral.com Have you already been prescribed VRAYLAR? Check out the VRAYLAR Starter Kit for helpful resources to get you started. See resources Additional resources Find a healthcare provider Use this tool to find a healthcare provider in your area and create a reminder for your next appointment. Search near you Save on VRAYLAR Learn more about the VRAYLAR savings program. See savings *Terms and conditions apply. Available to commercially insured patients only. See Terms and Conditions for full details. INDICATIONS AND USAGE VRAYLAR is approved in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) and for the short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder. IMPORTANT SAFETY INFORMATION What is the most important information I should know about VRAYLAR? Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis. VRAYLAR and antidepressants increase the risk of suicidal thoughts or actions in people 24 years of age and younger especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. 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 VRAYLAR or the antidepressant is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. VRAYLAR may cause serious side effects, including: Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death Neuroleptic malignant syndrome (NMS): Call your healthcare provider or go to the nearest hospital emergency room right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure. These can be symptoms of a rare but potentially fatal side effect called NMS. VRAYLAR should be stopped if you have NMS. Uncontrolled body movements (tardive dyskinesia or TD): VRAYLAR may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking VRAYLAR. Tardive dyskinesia may also start after you stop taking VRAYLAR. Late-occurring side effects: VRAYLAR stays in your body for a long time. Some side effects may not happen right away and can start a few weeks after starting VRAYLAR, or if your dose increases. Your healthcare provider should monitor you for side effects for several weeks after starting or increasing dose of VRAYLAR. Problems with your metabolism, such as: High blood sugar and diabetes: Increases in blood sugar can happen in some people who take VRAYLAR. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before or soon after starting VRAYLAR and regularly during treatment. Tell your healthcare provider if you have symptoms such as feeling very thirsty, very hungry, or sick to your stomach, urinating more than usual, feeling weak, tired, confused, or your breath smells fruity. Increased fat levels (cholesterol and triglycerides) in your blood: Your healthcare provider should check fat levels in your blood before or soon after starting VRAYLAR and during treatment. Weight gain: Weight gain has been reported with VRAYLAR. You and your healthcare provider should check your weight before and regularly during treatment. Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics. Your healthcare provider may do blood tests during the first few months of treatment with VRAYLAR. Decreased blood pressure (orthostatic hypotension): You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Falls: VRAYLAR may make you sleepy or dizzy, may cause a decrease in blood pressure when changing position (orthostatic hypotension), and can slow thinking and motor skills, which may lead to falls that can cause fractures or other injuries. Seizures (convulsions) Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities: Do NOT drive, operate machinery, or do other dangerous activities until you know how VRAYLAR affects you. VRAYLAR may make you drowsy. Increased body temperature: Do not become too hot or dehydrated during VRAYLAR treatment. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water. Difficulty swallowing that can cause food or liquid to get into your lungs Who should not take VRAYLAR? Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat). What should I tell my healthcare provider before taking VRAYLAR? Tell your healthcare provider about any medical conditions and if you: have or had heart problems or a stroke have or had low or high blood pressure have or had diabetes or high blood sugar in you or your family have or had high levels of total cholesterol, LDL-cholesterol, or triglycerides; or low levels of HDL-cholesterol have or had seizures (convulsions) have or had kidney or liver problems have or had low white blood cell count are pregnant or plan to become pregnant. VRAYLAR may harm your unborn baby. Taking VRAYLAR during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take VRAYLAR during pregnancy. There is a pregnancy exposure registry for women who are exposed to VRAYLAR during pregnancy. If you become pregnant or think you are pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . are breastfeeding or plan to breastfeed. It is not known if VRAYLAR passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with VRAYLAR. Tell your healthcare provider about all medicines that you take, including prescriptions, over-the-counter medicines, vitamins, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works. Do not start or stop any medicines while taking VRAYLAR without talking to your healthcare provider. What are the most common side effects of VRAYLAR? The most common side effects include difficulty moving or slow movements, tremors, uncontrolled body movements, restlessness and feeling like you need to move around, sleepiness, nausea, vomiting, indigestion, constipation, feeling tired, trouble sleeping, increased appetite, and dizziness. These are not all the possible side effects of VRAYLAR. VRAYLAR is available in 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, and 6 mg capsules. INDICATIONS AND USAGE VRAYLAR is a prescription medicine used: along with antidepressant medicines to treat major depressive disorder (MDD) in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) in adults to treat short-term (acute) manic or mixed episodes that happen with bipolar I disorder in adults and children ages 10 years and older Please see the full Prescribing Information , including Boxed Warnings, and Medication Guide . US-VRAA-250457 You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. HOME ABOUT ABBVIE PRESCRIBING INFORMATION SITEMAP ACCESSIBILITY STATEMENT CONTACT US TERMS OF USE PRIVACY NOTICE COOKIES SETTINGS YOUR PRIVACY CHOICES THIS SITE IS INTENDED FOR U.S. CONSUMERS ONLY. LICENSED FROM GEDEON RICHTER PLC. © 2025 ABBVIE. ALL RIGHTS RESERVED. VRAYLAR ® AND ITS DESIGN ARE TRADEMARKS OF ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED, AN ABBVIE COMPANY. VRAYPAY SM IS A SERVICE MARK OF ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED, AN ABBVIE COMPANY. IF YOU ARE A PATIENT, AND HAVE ANY QUESTIONS, PLEASE DISCUSS THEM WITH YOUR DOCTOR OR HEALTHCARE PROVIDER. FOR ADDITIONAL INFORMATION ABOUT VRAYLAR ® , CALL ABBVIE MEDICAL INFORMATION TOLL-FREE AT 1.800.678.1605. US-VRA-240147 You are now leaving VRAYLAR.com Links to other websites are provided as a service to you. By clicking "YES," you acknowledge and agree that AbbVie makes no guarantees that using any such support groups will result in your desired outcome. AbbVie accepts no responsibility for the content of other sites. Would you like to continue? YES NO US-VRA-230116 Tips about living with bipolar I Transcript View transcript Terms and Conditions AbbVie Inc. is providing this information to help patients find healthcare professionals in their area who have experience with therapies such as VRAYLAR ® (cariprazine). No fees have been received by AbbVie Inc. or paid to healthcare professionals for their inclusion in this locator directory. Inclusion of a healthcare professional in this directory neither represents an endorsement by or a recommendation from AbbVie Inc. regarding the qualifications of or medical care provided by the healthcare professional, nor implies that the healthcare professionals on the list will determine that any therapy such as VRAYLAR is right for you. The selection of a healthcare provider is an important decision that should not be based solely on the inclusion in this healthcare provider locator tool. AbbVie Inc. is the maker and marketer of VRAYLAR. CLOSE US-VRA-230116 Alec's bipolar I toolbox (part 2) Transcript View transcript Alec's bipolar I toolbox (part 3) Transcript View transcript Jacqueline's relief once she got her bipolar I diagnosis Transcript View transcript Christine grew up undiagnosed Transcript View transcript Journey to a bipolar I diagnosis Transcript View transcript Jon's journey through misdiagnosis Transcript View transcript Dailyn, a spoken word poet, addresses stigma Transcript View transcript Patient advice for others with bipolar I Transcript View transcript Heidi shares how bipolar I is part of who she is Transcript View transcript Bex opens up about bipolar I and therapy Transcript View transcript Gabe talks about how his mood changes with bipolar I Transcript View transcript Understanding possible triggers of bipolar I Transcript View transcript Why routines are important Transcript View transcript Why finding support with your bipolar I journey is important Transcript View transcript What bipolar I and mania symptoms may feel like Transcript View transcript Why is friend and family support so important when living with bipolar I disorder? Transcript View transcript Foods can affect your bipolar I moods Transcript View transcript Support systems for bipolar I Transcript View transcript Setting simple goals Transcript View transcript Being a partner in your care You’re greater than your bipolar I disorder symptoms. Watch our TV ad and ask if VRAYLAR may be able to help you manage your bipolar I. View Transcript View transcript Get the most out of your bipolar I virtual visit Transcript View transcript Strategies for everyday living Transcript View transcript Alec's bipolar I toolbox (part 1) Transcript View transcript Alec's family helps him manage bipolar I Transcript View transcript Terms and Conditions AbbVie Inc. is providing this information to help patients find healthcare professionals in their area who have experience with therapies such as VRAYLAR ® (cariprazine). No fees have been received by AbbVie Inc. or paid to healthcare professionals for their inclusion in this locator directory. Inclusion of a healthcare professional in this directory neither represents an endorsement by or a recommendation from AbbVie Inc. regarding the qualifications of or medical care provided by the healthcare professional, nor implies that the healthcare professionals on the list will determine that any therapy such as VRAYLAR is right for you. The selection of a healthcare provider is an important decision that should not be based solely on the inclusion in this healthcare provider locator tool. AbbVie Inc. is the maker and marketer of VRAYLAR. CLOSE US-VRA-230116 Transcript View transcript You are now leaving VRAYLAR.com Links to other websites are provided as a service to you. By clicking “YES,” you acknowledge and agree that AbbVie makes no guarantees that using any such support groups will result in your desired outcome. AbbVie accepts no responsibility for the content of other sites. Would you like to continue? YES NO US-VRA-220161 You are now leaving VRAYLAR.com Links to other websites are provided as a service to you. By clicking “YES,” you acknowledge and agree that AbbVie makes no guarantees that using any such support groups will result in your desired outcome. AbbVie accepts no responsibility for the content of other sites. Would you like to continue? YES NO US-VRA-220161 You are now being redirected to the VRAYLAR Savings Card activation website, where patients can activate and print a Savings Card. YES NO US-VRA-220161 You are now leaving VRAYLAR.com You are leaving the VRAYLAR (cariprazine) site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site, and AbbVie makes no guarantee that any such support groups will result in your desired outcome. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility. Conversely, the presence of this link does not imply the linked site's endorsement of VRAYLAR.com or AbbVie. Do you wish to leave this site? YES NO US-VRA-230116test For Healthcare Professionals The information provided in this website is intended for U.S. healthcare professionals only. I certify that I am a U.S. healthcare professional. If you choose “NO,” you will remain on the patient website. YES NO US-VRA-220161 You are now leaving VRAYLAR.com Links to other websites are provided as a service to you. AbbVie accepts no responsibility for the content of other sites. Would you like to continue? YES NO US-VRA-220161 You are now leaving VRAYLAR.com Links to other websites are provided as a service to you. AbbVie accepts no responsibility for the content of other sites. Would you like to continue? YES NO US-VRA-220161 Real People, Real Stories Transcript View transcript Terms and Conditions AbbVie Inc. is providing this information to help patients find healthcare professionals in their area who have experience with therapies such as VRAYLAR ® (cariprazine). No fees have been received by AbbVie Inc. or paid to healthcare professionals for their inclusion in this locator directory. Inclusion of a healthcare professional in this directory neither represents an endorsement by or a recommendation from AbbVie Inc. regarding the qualifications of or medical care provided by the healthcare professional, nor implies that the healthcare professionals on the list will determine that any therapy such as VRAYLAR is right for you. The selection of a healthcare provider is an important decision that should not be based solely on the inclusion in this healthcare provider locator tool. AbbVie Inc. is the maker and marketer of VRAYLAR. CLOSE US-VRA-230116 For Healthcare Professionals The information provided in this website is intended for U.S. healthcare professionals only. I certify that I am a U.S. healthcare professional. If you choose “NO,” you will remain on the patient website. YES NO US-VRA-230180 For residents of Puerto Rico By selecting ‘continue’ you will enter the VRAYLAR Puerto Rico website, which includes key information presented in Spanish. Cost & Savings information on this site is intended for Puerto Rico residents only. If you are a U.S. resident looking for cost information, please select ‘Back’ and visit the Cost & Savings page. Continue Back US-VRAA-240126 US-VRA-240106 For residents of Puerto Rico By selecting ‘continue’ you will enter the VRAYLAR Puerto Rico website, which includes key information presented in Spanish. Cost & Savings information on this site is intended for Puerto Rico residents only. If you are a U.S. resident looking for cost information, please select ‘Back’ and visit the Cost & Savings page. Continue Back US-VRA-240106 You are now leaving VRAYLAR.com You are leaving the VRAYLAR (cariprazine) site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility. Conversely, the presence of this link does not imply the linked site's endorsement of VRAYLAR.com or AbbVie. Do you wish to leave this site? YES NO US-VRA-230180 You are now leaving VRAYLAR.com Links to other websites are provided as a service to you. AbbVie accepts no responsibility for the content of other sites. Would you like to continue? YES NO US-VRAA-220054 For Healthcare Professionals The information provided in this website is intended for U.S. healthcare professionals only. I certify that I am a U.S. healthcare professional. If you choose “NO,” you will remain on the patient website. YES NO US-VRA-230180 You are now leaving VRAYLAR.com You are leaving the VRAYLAR (cariprazine) site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility. Conversely, the presence of this link does not imply the linked site's endorsement of VRAYLAR.com or AbbVie. Do you wish to leave this site? Yes No US-VRA-230180 For residents of Puerto Rico By selecting ‘continue’ you will enter the VRAYLAR Puerto Rico website, which includes key information presented in Spanish. Cost & Savings information on this site is intended for Puerto Rico residents only. If you are a U.S. resident looking for cost information, please select ‘Back’ and visit the Cost & Savings page. Continue Back US-VRAA-240126 US-VRA-240106 INDICATIONS AND USAGE VRAYLAR is a prescription medicine used in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) and for the short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder. IMPORTANT SAFETY INFORMATION What is the most important information I should know about VRAYLAR? Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis. IMPORTANT SAFETY INFORMATION Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like INDICATIONS AND USAGE VRAYLAR is a prescription medicine used in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) and for the short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder. IMPORTANT SAFETY INFORMATION What is the most important information I should know about VRAYLAR? Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis. IMPORTANT SAFETY INFORMATION Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like INDICATIONS AND USAGE VRAYLAR is approved in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) and for the short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder. IMPORTANT SAFETY INFORMATION What is the most important information I should know about VRAYLAR? Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis. VRAYLAR and antidepressants increase the risk of suicidal thoughts or actions in people 24 years of age and younger especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. 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 VRAYLAR or the antidepressant is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. VRAYLAR may cause serious side effects, including: Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death Neuroleptic malignant syndrome (NMS): Call your healthcare provider or go to the nearest hospital emergency room right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure. These can be symptoms of a rare but potentially fatal side effect called NMS. VRAYLAR should be stopped if you have NMS. Uncontrolled body movements (tardive dyskinesia or TD): VRAYLAR may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking VRAYLAR. Tardive dyskinesia may also start after you stop taking VRAYLAR. Late-occurring side effects: VRAYLAR stays in your body for a long time. Some side effects may not happen right away and can start a few weeks after starting VRAYLAR, or if your dose increases. Your healthcare provider should monitor you for side effects for several weeks after starting or increasing dose of VRAYLAR. Problems with your metabolism, such as: High blood sugar and diabetes: Increases in blood sugar can happen in some people who take VRAYLAR. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before or soon after starting VRAYLAR and regularly during treatment. Tell your healthcare provider if you have symptoms such as feeling very thirsty, very hungry, or sick to your stomach, urinating more than usual, feeling weak, tired, confused, or your breath smells fruity. Increased fat levels (cholesterol and triglycerides) in your blood: Your healthcare provider should check fat levels in your blood before or soon after starting VRAYLAR and during treatment. Weight gain: Weight gain has been reported with VRAYLAR. You and your healthcare provider should check your weight before and regularly during treatment. Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics. Your healthcare provider may do blood tests during the first few months of treatment with VRAYLAR. Decreased blood pressure (orthostatic hypotension): You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Falls: VRAYLAR may make you sleepy or dizzy, may cause a decrease in blood pressure when changing position (orthostatic hypotension), and can slow thinking and motor skills, which may lead to falls that can cause fractures or other injuries. Seizures (convulsions) Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities: Do NOT drive, operate machinery, or do other dangerous activities until you know how VRAYLAR affects you. VRAYLAR may make you drowsy. Increased body temperature: Do not become too hot or dehydrated during VRAYLAR treatment. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water. Difficulty swallowing that can cause food or liquid to get into your lungs Who should not take VRAYLAR? Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat). What should I tell my healthcare provider before taking VRAYLAR? Tell your healthcare provider about any medical conditions and if you: have or had heart problems or a stroke have or had low or high blood pressure have or had diabetes or high blood sugar in you or your family have or had high levels of total cholesterol, LDL-cholesterol, or triglycerides; or low levels of HDL-cholesterol have or had seizures (convulsions) have or had kidney or liver problems have or had low white blood cell count are pregnant or plan to become pregnant. VRAYLAR may harm your unborn baby. Taking VRAYLAR during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take VRAYLAR during pregnancy. There is a pregnancy exposure registry for women who are exposed to VRAYLAR during pregnancy. If you become pregnant or think you are pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . are breastfeeding or plan to breastfeed. It is not known if VRAYLAR passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with VRAYLAR. Tell your healthcare provider about all medicines that you take, including prescriptions, over-the-counter medicines, vitamins, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works. Do not start or stop any medicines while taking VRAYLAR without talking to your healthcare provider. What are the most common side effects of VRAYLAR? The most common side effects include difficulty moving or slow movements, tremors, uncontrolled body movements, restlessness and feeling like you need to move around, sleepiness, nausea, vomiting, indigestion, constipation, feeling tired, trouble sleeping, increased appetite, and dizziness. These are not all the possible side effects of VRAYLAR. VRAYLAR is available in 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, and 6 mg capsules. INDICATIONS AND USAGE VRAYLAR is a prescription medicine used: along with antidepressant medicines to treat major depressive disorder (MDD) in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) in adults to treat short-term (acute) manic or mixed episodes that happen with bipolar I disorder in adults and children ages 10 years and older Please see the full Prescribing Information , including Boxed Warnings, and Medication Guide . US-VRAA-250457