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Common Questions
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.
Although you may sometimes feel isolated or alone, there are millions of Americans with bipolar I disorder.
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.
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.
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.
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.
VRAYLAR® (cariprazine) is approved in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) and for the short-term treatment of manic or mixed episodes that happen with bipolar I disorder.
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.
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.
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.
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.
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).
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.
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.
Weight gain has been reported in patients with bipolar I disorder taking VRAYLAR. In 6-week and 8-week bipolar depression studies, patients who took VRAYLAR experienced an average weight gain of 1.2 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.
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.
An increase in cholesterol has been reported with VRAYLAR. Your healthcare provider should check your cholesterol and triglyceride levels before and during treatment.
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.
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).
The VRAYLAR Savings program provides eligible patients with copay assistance. Depending on insurance coverage, eligible patients may pay as little as $5 for 30- or 90-day prescription fills. In such instances, eligible patients who have not previously registered for a VRAYLAR® (cariprazine) savings card may pay as little as $0 for their first two (2) 30-day fills.
Eligible patients whose insurer does not cover VRAYLAR® (cariprazine) or where coverage restrictions have not been satisfied may pay as little as $75 per 30-day supply for each of up to twelve (12) prescription fills. Check with your pharmacist for your copay discounts. Maximum savings limit applies; patient out-of-pocket expenses may vary.
This offer is not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs.
You can register for a savings card online or receive a physical card from your doctor.
This offer is valid only for eligible patients 18 years of age or older.
The card must be activated on the VRAYLAR Savings Card website and presented at the pharmacy counter at time prescription is filled.
See program terms, conditions, and eligibility criteria at https://www.allergansavingscard.com/vraylar. For questions about the program, including savings on mail-order prescriptions, please call 1-844-226-2461.
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. Offer applies only to prescriptions filled before the program expires on December 31, 2022.
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.
Antidepressants may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed. Depression and other serious 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 an 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)
- Impaired judgment, thinking, and motor skills: 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
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. 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 were 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.
INDICATION AND USAGEVRAYLAR is approved in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) and for the short-term treatment of manic or mixed episodes that happen with bipolar I disorder.
Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide.
Less
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.
Antidepressants may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed. Depression and other serious 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 an 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)
- Impaired judgment, thinking, and motor skills: 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
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. 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 were 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.
INDICATION AND USAGEVRAYLAR is approved in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) and for the short-term treatment of manic or mixed episodes that happen with bipolar I disorder.
Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide.