FAQs | 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 Frequently asked questions (FAQs) I want to learn about: Bipolar I disorder About VRAYLAR Taking VRAYLAR Possible side effects VRAYLAR savings Bipolar I disorder What is bipolar I disorder? Bipolar I disorder is a condition that causes periods of severe changes in your mood, activity levels, energy, and ability to carry out everyday tasks. While anyone can develop bipolar I disorder, it often starts in the late teen or early adult years and lasts a lifetime. Children and older adults may develop bipolar I disorder as well. Medical researchers believe that it can result from many factors, including an imbalance of certain chemicals in the brain called neurotransmitters, which may be too high or too low. Learn about common symptoms of bipolar I disorder . Is bipolar I disorder common? Although you may sometimes feel isolated or alone, there are three million Americans with bipolar I disorder. How is bipolar I disorder diagnosed? Talking with a doctor or other licensed mental health professional is the first step for anyone who thinks he or she may have bipolar I disorder. The doctor can complete a physical exam to rule out other conditions. If the problems are not caused by other illnesses, the doctor may conduct a mental health evaluation or provide a referral to a trained mental health professional, such as a psychiatrist, who is experienced in diagnosing and treating bipolar I disorder. Do you think you might have bipolar I disorder? Complete the Mood Disorder Questionnaire . How long does bipolar I disorder last? Bipolar I disorder is a chronic condition. That means it is lifelong and there is no cure. But for many people, the symptoms may be helped with treatment. Is bipolar I disorder hereditary? Bipolar I disorder is seen more often in people with a sibling or parent (a first-degree relative) who has the condition. Research is being done to try to determine the genes that may be linked to bipolar I disorder. What else can I do to help treat my bipolar I disorder? In addition to medication, you may better manage mood swings with a comprehensive approach that includes talk therapy, building a strong support network, tracking symptoms over time, and making healthy choices a habit. Your support system may include friends, family, or patient support groups who can help you stay consistent with your overall treatment. My Mood Matters from VRAYLAR features articles, tools, and videos designed to help you reach achievable wellness goals as part of a comprehensive treatment approach to managing your bipolar I . Explore the Mood Tracker . About VRAYLAR What is VRAYLAR? VRAYLAR ® (cariprazine) 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. How does VRAYLAR work? VRAYLAR is thought to affect the activity of neurotransmitters such as dopamine and serotonin, which may be too high or too low. However, the exact way VRAYLAR works is unknown. Taking VRAYLAR What should I let my healthcare professional know before starting VRAYLAR? Tell your healthcare provider about any medical conditions and if you: have or have had heart problems or a stroke have or have had low or high blood pressure have or have had diabetes or high blood sugar in you or your family have or have had high levels of total cholesterol, LDL-cholesterol, or triglycerides; or low levels of HDL-cholesterol have or have had seizures (convulsions) have or have had kidney or liver problems have or have had low white blood cell count are pregnant or plan to become pregnant. VRAYLAR may harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take 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. How should I take VRAYLAR? VRAYLAR is an oral capsule that is taken once daily with or without food. It is important that you take your prescribed dose of VRAYLAR as directed, even if you start to feel better. When will VRAYLAR start working? Medications like VRAYLAR tend to work gradually, so it may take some time for you to notice your symptoms improve. That’s why it’s important to take VRAYLAR exactly as prescribed. 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). Possible side effects 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, and indigestion. These are not all possible side effects of VRAYLAR. Learn more about other possible side effects . What do I do if I think I am having side effects? Have you ever wondered, “Could what I’m feeling be a side effect of my medication?” Call your healthcare provider right away and explain in detail what you are experiencing so they can tell you what to do. Always call your healthcare provider if you have questions about your medication or your dosing. Does VRAYLAR cause weight gain? In VRAYLAR clinical trials, weight change reported was ≤ 1.5 lb. Weight gain may occur. You and your doctor should monitor your weight regularly. In 6-week and 8-week bipolar I depression studies, patients who took VRAYLAR 1.5 mg/day experienced an average weight gain of 1.5 pounds, patients who took VRAYLAR 3 mg/day experienced an average weight gain of 0.9 pounds compared to those on placebo who lost 0.2 pounds. In 3-week bipolar mania studies, patients who took VRAYLAR experienced an average weight gain of 1.1 pounds, compared to those on placebo who gained 0.4 pounds. Will VRAYLAR affect my blood sugar? 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. Will VRAYLAR affect my cholesterol? An increase in cholesterol has been reported with VRAYLAR. Your healthcare provider should check your cholesterol and triglyceride levels before and during treatment. Will VRAYLAR make me feel sleepy or drowsy? Feeling sleepy or drowsy has been reported with VRAYLAR. In 6-week and 8-week bipolar I depression studies, about 7% of patients who took VRAYLAR felt sleepy or drowsy, compared to 4% of patients taking placebo. At a higher dose in 3-week bipolar I mania clinical studies, 8% of patients with bipolar I disorder who took VRAYLAR felt sleepy or drowsy. In comparison, 4% of patients taking placebo felt sleepy or drowsy. Will VRAYLAR make me feel restless? Feeling restless has been reported with VRAYLAR. In the 6-week and 8-week bipolar I depression clinical studies, 10% of patients with bipolar I disorder felt restless (akathisia). At a higher dose in the 3-week bipolar I mania clinical studies, 21% of patients with bipolar I disorder felt restless (akathisia). VRAYLAR savings What is the VRAYLAR savings program? The VRAYLAR savings program is a co-pay assistance program that is available to patients with commercial insurance coverage for VRAYLAR ® (cariprazine) who meet eligibility criteria. This co-pay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare, Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law. Offer subject to change or termination without notice. Restrictions, including monthly maximums, may apply. This is not health insurance. For full Terms and Conditions, visit vraypay.com or call 1-800-761-0436 for additional information. To learn about AbbVie’s privacy practices and your privacy choices, visit https://privacy.abbvie How can I get a savings card? You can register for a savings card online or receive a physical card from your doctor. Are there age requirements to get a VRAYLAR savings card? This offer is valid only for eligible patients 18 years of age or older. How do I use the VRAYLAR savings card? Present the VRAYLAR Savings Card at the pharmacy counter at time prescription is filled. See program terms, conditions, and eligibility criteria at https://vraylar.com/savings-sign-up . For questions about the program, including savings on mail-order prescriptions, please call 1-844-226-2461. How many times can I use my savings card? For eligible patients, this offer is valid for up to twelve (12) prescription fills of a 30-day supply or up to four (4) prescription fills of a 90-day supply of VRAYLAR ® (cariprazine). * Additional resources Just starting VRAYLAR? The Starter Kit contains helpful resources for your journey. Browse the kit Save on VRAYLAR Eligible patients may pay as little as $0 for 30-day or 90-day fills of VRAYLAR* † Get your savings card † Terms and Conditions apply. See Eligibility Criteria below. Find a healthcare provider Use our tool to locate a provider in your area. Search near you * Eligibility: Available to patients with commercial insurance coverage for VRAYLAR ® (cariprazine) who meet eligibility criteria. This co-pay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law. Offer subject to change or termination without notice. Restrictions, including monthly maximums, may apply. This is not health insurance. For full Terms and Conditions, visit VRAYLARsavingscard.com or call 1-800-761-0436 for additional information. To learn about AbbVie’s privacy practices and your privacy choices, visit https://abbv.ie/corpprivacy 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-240171 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 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 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 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