Real Patient Experiences with VRAYLAR® (cariprazine) Skip to Main Content Contact Medical Information Prescribing Information Patient Site Savings Cards Request Samples Speaker Program Request a Rep Indications Adjunctive MDD Overview Bipolar I Overview Schizophrenia Efficacy Adjunctive MDD Bipolar I Depression Bipolar I Acute Manic or Mixed Episodes Schizophrenia Tolerability & Safety Mechanism of Action Dosing Savings & Resources Access Savings Resources VRAYLAR Videos Speaker Program Request a Rep VRAYLAR videos Hear real people discuss their experiences with VRAYLAR, learn how VRAYLAR is thought to work, and more. Patient stories Patient MOA videos Patient stories Hear from real patients as they talk about their journeys with MDD and BP-I and share their experiences with VRAYLAR. If you'd like to share these videos with your patients, encourage them to visit vraylar.com . Transcript Transcript Hear about Kami’s Experience with VRAYLAR Text on screen VRAYLAR USE VRAYLAR is a prescription medicine used along with antidepressant medicines to treat major depressive disorder in adults. Individual results may vary. Please see Safety Considerations at the end of this video. Stay tuned for Kami’s story on how she manages major depressive disorder (commonly referred to as depression). Text on screen Kami Living with major depressive disorder VO: My name is Kami. I live in West Virginia. I'm a super proud mom of my little girl and I was diagnosed with major depressive disorder. VO: The most important thing in my world is Elodie number one and then my family. We've always all been close. VO: I was a teenager when I first started noticing that something wasn't right. Not wanting to get out of bed, not wanting to be around anybody, I wanted to isolate myself. VO: It was getting to the point where I couldn't handle the symptoms on my own. I had to seek professional help. VO: When I went to the doctor, I was diagnosed with major depressive disorder. VO: I took quite a few years to find a treatment plan that worked for me. Quite a few different doctors. I felt like they weren't listening to what I was saying. The doctor I have now, we'll talk through things. We work together on it. And we decided on the medicine together. VO: I was taking an antidepressant and it was helping my symptoms, but it wasn't taking care of all the symptoms I was having. And I was still having my down days. That's when I went back to the doctor. VO: My doctor added VRAYLAR to also help manage my depression. Text on screen VRAYLAR added to an antidepressant has been shown to help reduce overall depression symptoms, on average, better than an antidepressant alone. Observed in 6- and 8-week studies. Individual results may vary. VO: VRAYLAR plus my antidepressant helped me treat my depression symptoms. VO: Now that my symptoms are better controlled I can navigate through life a little bit better. VO: Other than medicine, I journal a lot. Journaling helps me get it out of my head. I handwrite every day my thoughts and what's going on in life. VO: Most of my support system is my family. I socialize, go to work, and take care of my daughter. I have a lot of good days that give me more time to spend with my daughter. VO: We go to the park a lot. We go to what we call our secret park. It's just a smaller park in our town. VO: Having Elodie definitely helps a lot because it does keep my focus on her. She’s my little world. My world revolves around her. And she’s the one that helps me get through things. She gives me all the motivation in the world so that I can be there for her and watch her go through school and go through life and be the greatest person she can be. And I want to watch her grow up and thrive and do good things in life. VO: If you've just been diagnosed with MDD, take your time to be patient. Put one foot in front of the other. It's important to seek help because you can't do it on your own. VO: Talk to your doctor or your health care provider about what you can do to help manage your symptoms. VO: I want to share my story because if there’s one person out there that I can help not feel alone and not feel like they are the only ones that go through this, then that will make me happy. Text on screen Keep watching to see Safety Considerations for VRAYLAR. VO2/Text on screen: IMPORTANT SAFETY CONSIDERATIONS VRAYLAR may cause serious side effects, including: Elderly people with dementia-related psychosis have increased risk of death or stroke. VRAYLAR is not approved in elderly patients with dementia-related psychosis. Tell your doctor about unusual changes in behavior or suicidal thoughts. VRAYLAR and antidepressants may increase suicidal thoughts and actions in some children and young adults, especially in the first few months of treatment or when the dose is changed. VRAYLAR is not approved for people under 18 years of age. Seek medical help right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS), a rare but potentially fatal side effect. VRAYLAR may cause uncontrolled body movements (tardive dyskinesia or TD) in your face, tongue, or other body parts, which may be permanent. VRAYLAR may cause problems with your metabolism, including increased cholesterol or triglycerides, weight gain, high blood sugar, and diabetes. Extremely high blood sugar can lead to coma or death. VRAYLAR may also cause low white blood cell count, decreased blood pressure, falls, seizures (convulsions), sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities, increased body temperature, and difficulty swallowing. Do not take VRAYLAR if you are allergic to any of its ingredients. The most common side effects of VRAYLAR 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. Some side effects may happen a few weeks after starting VRAYLAR or if your dose increases. You and your doctor should monitor, discuss, and report any adverse events if they occur. These are not all the possible side effects of VRAYLAR. Please see additional Important Safety Information on the page below. Please also see full Prescribing Information, including Boxed Warnings, and Medication Guide. LICENSED FROM GEDEON RICHTER PLC. US-VRAA-240104 Hear about Kami’s Experience with VRAYLAR Kami was diagnosed with major depressive disorder. Even though she was taking an antidepressant, she still struggled with lingering depression symptoms. Watch Kami's story and see her experience with adding VRAYLAR to her antidepressant and how it helped reduce her depression symptoms. The person featured in this video is sharing her individual experience with VRAYLAR. Individual experiences with the condition and treatment will vary. Watch more videos video Alec's bipolar I toolbox (part 1) Alec shares his treatment journey and the tools that help him manage his bipolar I. video Alec's bipolar I toolbox (part 2) Alec shares his treatment journey and the tools that help him manage his bipolar I. video Alec's bipolar I toolbox (part 3) Alec shares his treatment journey and the tools that help him manage his bipolar I. Patient MOA videos Help educate your patients about how VRAYLAR is thought to work. If you'd like to share these videos with your patients, encourage them to visit vraylar.com . Transcript Transcript How is VRAYLAR Thought to Work to Treat MDD? Voice Over (VO): If you have depression and take an antidepressant, but you haven’t made as much progress as you hoped, you may feel frustrated or stuck. Text on Screen VRAYLAR is an add-on treatment for MDD in adults VRAYLAR is a prescription medicine used along with antidepressant medicines to treat major depressive disorder (MDD) in adults. Continue watching to see Important Safety Information. (VO): Your healthcare provider may suggest an add-on treatment like VRAYLAR. Text on Screen Taken with your current antidepressant for MDD. Antidepressant [bottle] +VRAYLAR (cariprazine) capsules 1.5mg • 3mg [bottle] VO: VRAYLAR can be taken with your current antidepressant if you still have unresolved depression symptoms. Text on Screen VRAYLAR (cariprazine) capsules + antidepressant. Individual results may vary. VO: When taken with an antidepressant, VRAYLAR is clinically proven to help relieve overall depression symptoms better than an antidepressant alone. Text on Screen Let’s look inside the brain. VO: Let’s look at what may happen inside your brain when you have depression and how VRAYLAR and some antidepressants are believed to work. Text on Screen Control Center VO: The brain is the control center of the human body and nervous system. Within the nervous system, our neurons transmit chemical messages from 1 neuron to the receptor of the next. It is the receptor’s role to make use of these chemical messages. Text on Screen Norepinephrine Serotonin Dopamine VO: Scientists and healthcare providers believe that depression may occur when there are altered levels of 3 of the brain’s chemicals: norepinephrine, serotonin, and dopamine. The changes in levels of these 3 chemicals may play a role in mood. Text on Screen SSRIs: Selective serotonin reuptake inhibitors. SNRIs: Serotonin & Norepinephrine reuptake inhibitors. SSRIs & SNRIs The exact way these antidepressants work is not fully understood. VO: Commonly prescribed antidepressants, SSRIs and SNRIs are thought to act on the brain’s neurons to help regulate the levels of serotonin and norepinephrine, respectively. Dopamine may also play a role in mood. However, SSRIs and SNRIs are not thought to interact with dopamine. Text on Screen VRAYLAR works differently than an antidepressant. The exact way that VRAYLAR works is unknown. VO: VRAYLAR is thought to work differently than an antidepressant. Text on Screen The exact way that VRAYLAR works is unknown. VO: While the exact way that VRAYLAR works is unknown, one way to think about it is that it may act like a volume dial that can help regulate dopamine and serotonin in the brain. When there are low levels of dopamine and serotonin, VRAYLAR is thought to turn up activity related to these chemicals. And when there are high levels of dopamine and serotonin, VRAYLAR is thought to turn down activity related to these chemicals. This action of helping to manage these chemicals in the brain may help improve your mood. Text on Screen Ask your healthcare provider if adding VRAYLAR to your antidepressant is right for you. VRAYLAR (cariprazine) capsules 1.5mg • 3mg Continue watching for the Important Safety Information for VRAYLAR. See full Prescribing Information, including Boxed Warnings, and Medication Guide available on this website. VO: Are you interested in taking another approach to treating your depression symptoms? Ask your healthcare provider if adding VRAYLAR to your antidepressant is right for you. Continue watching for the Important Safety Information for VRAYLAR. Text on Screen (with VO to match) INDICATION AND USAGE VRAYLAR is a prescription medicine used along with antidepressant medicines to treat major depressive disorder (MDD) in adults. 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 may increase suicidal thoughts or actions in some children and young adults 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 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. 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. 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. Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide available on this website. 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. Text on Screen [Vraylar logo] Licensed from Gedeon Richter Plc. © 2024 AbbVie. All rights reserved. VRAYLAR ® and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company. US-VRAA-230151 How is VRAYLAR Thought to Work in MDD? Watch to see how VRAYLAR is thought to work in major depressive disorder when used along with antidepressant medicines. Watch more videos video How is VRAYLAR Thought to Work in BP-I? Watch to see how VRAYLAR is thought to work in BP-I. Get VRAYLAR resources BP-I=bipolar I disorder; MDD=major depressive disorder; MOA=mechanism of action. INDICATIONS AND USAGE VRAYLAR (cariprazine) is indicated in adults as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD), for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression), for the acute treatment of manic or mixed episodes associated with bipolar I disorder, and for the treatment of schizophrenia. IMPORTANT SAFETY INFORMATION WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Contraindication: VRAYLAR is contraindicated in patients with known hypersensitivity. Reactions have included rash, pruritus, urticaria, and reactions suggestive of angioedema. Cerebrovascular Adverse Reactions, Including Stroke: In clinical trials with antipsychotic drugs, elderly patients with dementia had a higher incidence of cerebrovascular adverse reactions, including fatalities, vs placebo. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with antipsychotic drugs. NMS may cause hyperpyrexia, muscle rigidity, delirium, and autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation, intensive symptomatic treatment, and monitoring. Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary, dyskinetic movements) and the likelihood it will become irreversible may increase with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. If signs and symptoms of TD appear, drug discontinuation should be considered. Late-Occurring Adverse Reactions: Adverse reactions may first appear several weeks after initiation of VRAYLAR, probably because plasma levels of cariprazine and its major metabolites accumulate over time. As a result, the incidence of adverse reactions in short-term trials may not reflect the rates after longer-term exposures. Monitor for adverse reactions, including extrapyramidal symptoms (EPS) or akathisia, and patient response for several weeks after starting VRAYLAR and after each dosage increase. Consider reducing the dose or discontinuing the drug. Metabolic Changes: Atypical antipsychotics, including VRAYLAR, have caused metabolic changes, such as: Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. Assess fasting glucose before or soon after initiation of treatment, and monitor periodically during long-term treatment. Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after starting an antipsychotic, obtain baseline fasting lipid profile and monitor periodically during treatment. Weight Gain: Weight gain has been observed with VRAYLAR. Monitor weight at baseline and frequently thereafter. Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia have been reported with antipsychotics, including VRAYLAR. Agranulocytosis (including fatal cases) has been reported with other antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue VRAYLAR at the first sign of a clinically significant decline in WBC and in severely neutropenic patients. Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope, with the greatest risk during initial titration and with dose increases. Monitor orthostatic vital signs in patients predisposed to hypotension and in those with cardiovascular/cerebrovascular diseases. Falls: VRAYLAR may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotics and recurrently for patients on long-term therapy. Seizures: Use VRAYLAR with caution in patients with a history of seizures or with conditions that lower the seizure threshold. Potential for Cognitive and Motor Impairment: Somnolence was reported with VRAYLAR. Caution patients about performing activities requiring mental alertness (eg, operating hazardous machinery or a motor vehicle). Body Temperature Dysregulation: Use VRAYLAR with caution in patients who may experience conditions that increase body temperature (eg, strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics). Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics. Antipsychotic drugs, including VRAYLAR, should be used cautiously in patients at risk for aspiration. Drug Interactions: Strong and moderate CYP3A4 inhibitors increase VRAYLAR concentrations, so VRAYLAR dose reduction is recommended. Concomitant use with CYP3A4 inducers is not recommended. Adverse Reactions: The most common adverse reactions in adult clinical trials (≥5% and at least twice the rate of placebo) are listed below: Adjunctive Treatment of Major Depressive Disorder: In 6-week, fixed-dose trials the incidences within the recommended doses (VRAYLAR 1.5 mg/day + antidepressant therapy [ADT] or 3 mg/day + ADT vs placebo + ADT) were akathisia (7%, 10% vs 2%), nausea (7%, 6% vs 3%), and insomnia (9%, 10% vs 5%). In one 8-week flexible-dose trial, incidences within the doses (VRAYLAR 1-2 mg/day + antidepressant therapy [ADT] or 2-4.5 mg/day + ADT vs placebo + ADT) were akathisia (8%, 23% vs 3%), restlessness (8%, 8% vs 3%), fatigue (7%, 10% vs 4%), constipation (2%, 5% vs 2%), nausea (7%, 13% vs 5%), increased appetite (2%, 5% vs 2%), dizziness (4%, 5% vs 2%), insomnia (14%, 16% vs 8%), and extrapyramidal symptoms (12%, 18% vs 5%). Bipolar Mania: The incidences within the recommended dose range (VRAYLAR 3–6 mg/day vs placebo) were EPS (26% vs 12%), akathisia (20% vs 5%), vomiting (10% vs 4%), dyspepsia (7% vs 4%), somnolence (7% vs 4%), and restlessness (7% vs 2%). Bipolar Depression: The incidences within the recommended doses (VRAYLAR 1.5 mg/day or 3 mg/day vs placebo) were nausea (7%, 7% vs 3%), akathisia (6%, 10% vs 2%), restlessness (2%, 7% vs 3%), and EPS (4%, 6% vs 2%). Schizophrenia: The incidences within the recommended dose range (VRAYLAR 1.5–3 mg/day and 4.5–6 mg/day vs placebo) were EPS (15%, 19% vs 8%) and akathisia (9%, 13% vs 4%). 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 (cariprazine) is indicated for adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults, for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older, and for the treatment of schizophrenia in adult and pediatric patients 13 years of age and older. US-VRAA-250443 Please also see full Prescribing Information , including Boxed Warnings. Reference: VRAYLAR [package insert]. North Chicago, IL: AbbVie Inc.; 2024. Important Safety Information Full Prescribing Information About AbbVie Site Map Accessibility Statement Contact Us Terms of Use Privacy Notice Cookies Settings Your Privacy Choices US-VRAA-240301 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 . 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. Patient MOA videos Help educate your patients about how VRAYLAR is thought to work. If you'd like to share these videos with your patients, encourage them to visit vraylar.com . Transcript Transcript How is VRAYLAR Thought to Work to Treat BP-I Text on Screen 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. Continue watching to see Important Safety Information. Voice Over (VO) If you’re struggling with the highs and lows of bipolar I disorder, VRAYLAR may be able to help. VRAYLAR is a prescription medicine used to treat the highs and lows of bipolar I disorder. Bipolar I disorder can cause high and low mood swings also known as manic and depressive episodes, respectively. You may even experience depressive and manic symptoms at the same time, which is known as a mixed episode. Text on Screen VRAYLAR (cariprazine) capsules 1.5mg • 3mg • 4.5mg • 6mg Bipolar I Depression, Acute Mixed Episodes, Acute Mania Individual results may vary. VO: VRAYLAR can provide full-spectrum relief for all bipolar I disorder symptoms: bipolar I depression, acute mixed episodes, and acute mania. Text on Screen Let’s look inside the brain Control center VO: Let’s look at what may happen inside your brain when you have bipolar I disorder and how VRAYLAR is believed to work. The brain is the control center of the human body and nervous system. Within the nervous system, our neurons transmit chemical messages from one neuron to the receptor of the next. It is the receptor’s role to make use of these chemical messages. Text on Screen Norepinephrine Serotonin Dopamine VO: Scientists and healthcare providers believe that bipolar I disorder may occur when there are altered levels of three of the brain’s chemicals: norepinephrine, serotonin, and dopamine. The changes in levels of these three chemicals may play a role in mood. Text on Screen Agonists VO: Medications called agonists are thought to turn up activity related to specific chemicals. Text on Screen Antagonists VO: Medications called antagonists are thought to turn down activity related to specific chemicals. Text on Screen How does VRAYLAR work? Partial agonist The exact way that VRAYLAR works is unknown. VO: While the exact way that VRAYLAR works is unknown, it is thought to work as a partial agonist, meaning it can work in 2 ways: by either turning up OR turning down activity related to chemicals, as needed. One way to think about VRAYLAR is that it may act like a volume dial that can help regulate dopamine and serotonin in the brain. When there are low levels of dopamine and serotonin, VRAYLAR is thought to turn up activity related to these chemicals. And when there are high levels of dopamine and serotonin, VRAYLAR is thought to turn down activity related to these chemicals. This action of helping to manage these chemicals in the brain may help control your mood. Are you ready to take on your bipolar I disorder? Text on Screen Ask your healthcare provider if full-spectrum treatment with VRAYLAR is right for you. VRAYLAR (cariprazine) capsules 1.5mg • 3mg • 4.5mg • 6mg Continue watching for Important Safety Information. See full Prescribing Information, including Boxed Warnings, and Medication Guide available on this website. VO: Ask your doctor if full-spectrum treatment with VRAYLAR is right for you. Continue watching for the Important Safety Information for VRAYLAR. Text on Screen (with VO to match) INDICATION 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 may increase suicidal thoughts or actions in some children and young adults 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 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. 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. 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. Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide available on this website. 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. Text on Screen [Vraylar logo] Licensed from Gedeon Richter Plc. © 2024 AbbVie. All rights reserved. VRAYLAR ® and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company. US-VRA-230244 How is VRAYLAR Thought to Work to Treat BP-I? Watch to see how VRAYLAR is thought to work to treat BP-I. Patient stories Hear from real patients as they talk about their journeys with MDD and BP-I, and share their experiences with VRAYLAR. If you'd like to share these videos with your patients, encourage them to visit vraylar.com . Transcript Transcript Alec's bipolar I toolbox (part 3) Text on screen Real people, real stories. Alec's Dream VO/Text on screen This is Alec’s story. He is living with bipolar I disorder and is currently taking VRAYLAR. His experience may not be representative of all patients. VRAYLAR is approved for depressive, and acute manic or mixed episodes of bipolar I in adults. Please see Important Safety Information, including Boxed Warnings, throughout this video. Text on screen Alec Husband and father VRAYLAR patient. Results may vary. Alec: Hi, my name is Alec. I was diagnosed with bipolar I 24 years ago and I take VRAYLAR. I would love to be an advocate. I would love to speak for the people that have gone through the things that I’ve gone through and have illnesses similar to mine. A dream of mine would be to help others, not just people that suffer from illnesses like mine, but the supporters of people that have illnesses. There were so many unanswered questions, and I wish that there had been more people to help my family understand what was happening to me, just as much as my doctors and physicians. You can’t be afraid of treatment and you can’t be afraid of a diagnosis because of what you think your journey might be. With VRAYLAR, my bipolar I symptoms are improving. I was really excited that I had found a medicine like VRAYLAR that reduces both my depressive and manic symptoms. VO/Text on screen VRAYLAR effectively treats bipolar I depression and short-term manic or mixed episodes that happen with bipolar I disorder in adults. Alec: Getting started on VRAYLAR was pretty easy and straightforward. I take it once a day with or without food. VO/Text on screen VRAYLAR is not approved for the treatment of patients with dementia-related psychosis or for people under 18. Elderly patients with dementia have an increased risk of death or stroke. Call your doctor about unusual changes in behavior or suicidal thoughts. VRAYLAR and antidepressants can increase these in children and young adults. Report fever, stiff muscles, or confusion, which may mean a life threatening reaction, or uncontrollable muscle movements which may be permanent. Metabolic changes such as high cholesterol, high blood sugar, and weight gain, may occur. Extremely high blood sugar can lead to coma or death. Text on screen Keep watching to see additional Important Safety Information, including Boxed Warnings. Alec: VRAYLAR has given me hope that my bipolar I symptoms can be managed and improved. Find something in your life that’ll motivate you to keep pushing forward, because you are greater than your bipolar I . Text on screen You are greater than your bipolar I . Ask about Vraylar (cariprazine) capsules 1.5mg ᐧ 3mg ᐧ 4.5mg ᐧ 6mg VO/Text on screen VRAYLAR is approved in adults to treat bipolar I depression and short-term 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 may increase suicidal thoughts or actions in some children and young adults 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 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. 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. 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. INDICATION 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. Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide. 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. Text on screen [AbbVie logo] Licensed from Gedeon Richter Plc. © 2023 AbbVie. All rights reserved. VRAYLAR ® and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie Company. US-VRA-230121 Alec's bipolar I toolbox (part 3) Alec shares his treatment journey and the tools that help him manage his bipolar I. Patient stories Hear from real patients as they talk about their journeys with MDD and BP-I, and share their experiences with VRAYLAR. If you'd like to share these videos with your patients, encourage them to visit vraylar.com . Transcript Transcript Text on screen Real people, real stories. Alec and Fatherhood VO/Text on screen This is Alec’s story. He is living with bipolar I disorder and is currently taking VRAYLAR. His experience may not be representative of all patients. VRAYLAR is approved for depressive, and acute manic or mixed episodes of bipolar I in adults. Please see Important Safety Information, including Boxed Warnings, throughout this video. Text on screen Alec Husband and father VRAYLAR patient. Results may vary. Alec: My name is Alec. I have bipolar I . I’m a husband, I’m a father, I’m a jokester, but my kids probably wouldn’t agree. I love to take my sons fishing. They’ve gotten better at it than I am, which is encouraging, but disappointing at the same time. The thing that makes me the most proud to be a dad is seeing my sons come into their own, develop their own personalities, their own beliefs, their own sense of adventure. I was diagnosed with bipolar I 24 years ago. It's so hard to go through a struggle like this. That's why it's important to find a source of support, like family, to help keep you motivated and pushing you toward finding a treatment that can help manage your bipolar l symptoms. I learned about VRAYLAR from my doctor and we both decided it was a good option for me. I was really excited that I’d found a medicine that reduces both my depressive and manic symptoms. VO/Text on screen VRAYLAR effectively treats bipolar I depression and short-term manic or mixed episodes that happen with bipolar I disorder in adults. Alec: VRAYLAR has been affordable for me and that’s very important. And it fits into my routine because it’s just one pill a day. VO/Text on screen VRAYLAR is not approved for the treatment of patients with dementia-related psychosis or for people under 18. Elderly patients with dementia have an increased risk of death or stroke. Call your doctor about unusual changes in behavior or suicidal thoughts. VRAYLAR and antidepressants can increase these in children and young adults. Report fever, stiff muscles, or confusion, which may mean a life threatening reaction, or uncontrollable muscle movements, which may be permanent. Metabolic changes such as high cholesterol, high blood sugar, and weight gain, may occur. Extremely high blood sugar can lead to coma or death. Alec: My bipolar I symptoms are improving. Text on screen Keep watching to see additional Important Safety Information, including Boxed Warnings. Alec: I am greater than my bipolar I and so are you. Ask your doctor if VRAYLAR is right for you. Text on screen You are greater than your bipolar I . Ask about Vraylar (cariprazine) capsules 1.5mg ᐧ 3mg ᐧ 4.5mg ᐧ 6mg VO/Text on screen VRAYLAR is approved in adults to treat bipolar I depression and short-term 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 may increase suicidal thoughts or actions in some children and young adults 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 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. 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. 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. INDICATION 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. Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide. 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. Text on screen [AbbVie logo] Licensed from Gedeon Richter Plc. © 2023 AbbVie. All rights reserved. VRAYLAR ® and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie Company. US-VRA-230120 Alec's bipolar I toolbox (part 2) Alec shares his treatment journey and the tools that help him manage his bipolar I. Patient stories Hear from real patients as they talk about their journeys with MDD and BP-I, and share their experiences with VRAYLAR. If you'd like to share these videos with your patients, encourage them to visit vraylar.com . Transcript Transcript Alec's bipolar I toolbox (part 1) Text on screen Real people, real stories. Alec and his Toolbox VO/Text on screen This is Alec's story. He is living with bipolar I disorder and is currently taking VRAYLAR. His experience may not be representative of all patients. VRAYLAR is approved for depressive, and acute manic or mixed episodes of bipolar I in adults. Please see Important Safety Information, including Boxed Warnings, throughout this video. Text on screen Alec Husband and father VRAYLAR patient. Results may vary. Alec: This is my toolbox. So what I did with this toolbox was I wrote down these different coping mechanisms to help me get through tough times. The toolbox has been so helpful on my journey. The most important part of managing my bipolar I symptoms though, was finding a medication that worked for me. I learned about VRAYLAR from my doctor and we both decided it was a good option for me. Text on screen VRAYLAR Full-spectrum relief for all bipolar I symptoms Bipolar I Depression | Acute Mixed Episodes | Acute Mania Alec: Some medicines only treat the highs or the lows, VRAYLAR provides full-spectrum relief for all bipolar I symptoms. VO/Text on screen VRAYLAR effectively treats bipolar I depression and short-term manic or mixed episodes that happen with bipolar I disorder in adults. Alec: Getting started on VRAYLAR was pretty easy and straightforward. I take it once a day with or without food. VRAYLAR helped reduce the depressive and manic symptoms of my bipolar I . It helps balance my moods. And that was important to me. VO/Text on screen VRAYLAR is not approved for the treatment of patients with dementia-related psychosis or for people under 18. Elderly patients with dementia have an increased risk of death or stroke. Call your doctor about unusual changes in behavior or suicidal thoughts. VRAYLAR and antidepressants can increase these in children and young adults. Report fever, stiff muscles, or confusion, which may mean a life-threatening reaction, or uncontrollable muscle movements which may be permanent. Metabolic changes such as high cholesterol, high blood sugar, and weight gain, may occur. Extremely high blood sugar can lead to coma or death. Alec: Everyone's journey with bipolar I is different. Having a toolbox is so important. My father was one of the most important pieces of my support system. And just like my dad always told me, I say to anyone else out there, and you should say to yourself, “You got this.” Text on screen Keep watching to see additional Important Safety Information, including Boxed Warnings. You are greater than your bipolar I . Ask about Vraylar (cariprazine) capsules 1.5mg ᐧ 3mg ᐧ 4.5mg ᐧ 6mg VO/Text on screen VRAYLAR is approved in adults to treat bipolar I depression and short-term 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 may increase suicidal thoughts or actions in some children and young adults 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 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. 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. 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. INDICATION 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. Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide. 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. Text on screen [AbbVie logo] Licensed from Gedeon Richter Plc. © 2023 AbbVie. All rights reserved. VRAYLAR ® and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie Company. US-VRA-230119 Alec's bipolar I toolbox (part 1) Alec shares his treatment journey and the tools that help him manage his bipolar I. You are about to enter a site that is for U.S. Healthcare Professionals only. By selecting "Yes" below, you certify that you are a Healthcare Professional and that you wish to proceed to the Healthcare Professionals Only section on the AbbVie Medical Information site. Products or treatments described on this site are available in the U.S. but may not be available in all other countries. I am a licensed Healthcare Professional and wish to proceed to the Healthcare Professionals Only AbbVie Medical Information Site. Yes No US-VRAA-240301 WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for treatment of patients with dementia-related psychosis. WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for treatment of patients with dementia-related psychosis. INDICATIONS AND USAGE VRAYLAR (cariprazine) is indicated in adults as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD), for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression), for the acute treatment of manic or mixed episodes associated with bipolar I disorder, and for the treatment of schizophrenia. IMPORTANT SAFETY INFORMATION WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Contraindication: VRAYLAR is contraindicated in patients with known hypersensitivity. Reactions have included rash, pruritus, urticaria, and reactions suggestive of angioedema. Cerebrovascular Adverse Reactions, Including Stroke: In clinical trials with antipsychotic drugs, elderly patients with dementia had a higher incidence of cerebrovascular adverse reactions, including fatalities, vs placebo. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with antipsychotic drugs. NMS may cause hyperpyrexia, muscle rigidity, delirium, and autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation, intensive symptomatic treatment, and monitoring. Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary, dyskinetic movements) and the likelihood it will become irreversible may increase with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. If signs and symptoms of TD appear, drug discontinuation should be considered. Late-Occurring Adverse Reactions: Adverse reactions may first appear several weeks after initiation of VRAYLAR, probably because plasma levels of cariprazine and its major metabolites accumulate over time. As a result, the incidence of adverse reactions in short-term trials may not reflect the rates after longer-term exposures. Monitor for adverse reactions, including extrapyramidal symptoms (EPS) or akathisia, and patient response for several weeks after starting VRAYLAR and after each dosage increase. Consider reducing the dose or discontinuing the drug. Metabolic Changes: Atypical antipsychotics, including VRAYLAR, have caused metabolic changes, such as: Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. Assess fasting glucose before or soon after initiation of treatment, and monitor periodically during long-term treatment. Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after starting an antipsychotic, obtain baseline fasting lipid profile and monitor periodically during treatment. Weight Gain: Weight gain has been observed with VRAYLAR. Monitor weight at baseline and frequently thereafter. Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia have been reported with antipsychotics, including VRAYLAR. Agranulocytosis (including fatal cases) has been reported with other antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue VRAYLAR at the first sign of a clinically significant decline in WBC and in severely neutropenic patients. Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope, with the greatest risk during initial titration and with dose increases. Monitor orthostatic vital signs in patients predisposed to hypotension and in those with cardiovascular/cerebrovascular diseases. Falls: VRAYLAR may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotics and recurrently for patients on long-term therapy. Seizures: Use VRAYLAR with caution in patients with a history of seizures or with conditions that lower the seizure threshold. Potential for Cognitive and Motor Impairment: Somnolence was reported with VRAYLAR. Caution patients about performing activities requiring mental alertness (eg, operating hazardous machinery or a motor vehicle). Body Temperature Dysregulation: Use VRAYLAR with caution in patients who may experience conditions that increase body temperature (eg, strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics). Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics. Antipsychotic drugs, including VRAYLAR, should be used cautiously in patients at risk for aspiration. Drug Interactions: Strong and moderate CYP3A4 inhibitors increase VRAYLAR concentrations, so VRAYLAR dose reduction is recommended. Concomitant use with CYP3A4 inducers is not recommended. Adverse Reactions: The most common adverse reactions in adult clinical trials (≥5% and at least twice the rate of placebo) are listed below: Adjunctive Treatment of Major Depressive Disorder: In 6-week, fixed-dose trials the incidences within the recommended doses (VRAYLAR 1.5 mg/day + antidepressant therapy [ADT] or 3 mg/day + ADT vs placebo + ADT) were akathisia (7%, 10% vs 2%), nausea (7%, 6% vs 3%), and insomnia (9%, 10% vs 5%). In one 8-week flexible-dose trial, incidences within the doses (VRAYLAR 1-2 mg/day + antidepressant therapy [ADT] or 2-4.5 mg/day + ADT vs placebo + ADT) were akathisia (8%, 23% vs 3%), restlessness (8%, 8% vs 3%), fatigue (7%, 10% vs 4%), constipation (2%, 5% vs 2%), nausea (7%, 13% vs 5%), increased appetite (2%, 5% vs 2%), dizziness (4%, 5% vs 2%), insomnia (14%, 16% vs 8%), and extrapyramidal symptoms (12%, 18% vs 5%). Bipolar Mania: The incidences within the recommended dose range (VRAYLAR 3–6 mg/day vs placebo) were EPS (26% vs 12%), akathisia (20% vs 5%), vomiting (10% vs 4%), dyspepsia (7% vs 4%), somnolence (7% vs 4%), and restlessness (7% vs 2%). Bipolar Depression: The incidences within the recommended doses (VRAYLAR 1.5 mg/day or 3 mg/day vs placebo) were nausea (7%, 7% vs 3%), akathisia (6%, 10% vs 2%), restlessness (2%, 7% vs 3%), and EPS (4%, 6% vs 2%). Schizophrenia: The incidences within the recommended dose range (VRAYLAR 1.5–3 mg/day and 4.5–6 mg/day vs placebo) were EPS (15%, 19% vs 8%) and akathisia (9%, 13% vs 4%). 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 (cariprazine) is indicated for adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults, for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older, and for the treatment of schizophrenia in adult and pediatric patients 13 years of age and older. US-VRAA-250443 Please also see full Prescribing Information , including Boxed Warnings.