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VRAYLAR
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What Is VRAYLAR?

VRAYLAR is a once-a-day medication, taken with or without food, for the treatment of schizophrenia in adults.

In clinical studies, VRAYLAR was proven to help manage the overall symptoms of schizophrenia.

People who took VRAYLAR experienced significant improvement in their overall schizophrenia symptoms compared to those who took a placebo (sugar pill).

This means that their symptoms of schizophrenia were less severe than the symptoms of people who took a placebo.

People taking VRAYLAR also showed a decrease in the overall severity of their condition based on a specific research tool used by healthcare providers. That’s good news, because taking VRAYLAR may help you manage your schizophrenia symptoms and could be an important part of your treatment plan.

HOW VRAYLAR IS BELIEVED TO WORK

VRAYLAR is thought to affect the activity of neurotransmitters, which may be too high or too low.

However, the exact way VRAYLAR works is unknown.

Starting on VRAYLAR

Here are a few things to remember when taking VRAYLAR.

  • Take VRAYLAR once a day, with or without food
  • It is important that you take your prescribed dose of VRAYLAR as directed, even if you start to feel better
  • Do not stop taking VRAYLAR or change how much you take without checking with your healthcare provider first
  • If you have any questions about how to take VRAYLAR, speak with your healthcare provider

Take by mouth

With or without food

Take once
a day

GET PATIENT BROCHURE
QUESTIONS TO ASK YOUR HEALTHCARE PROVIDER

STAYING ON VRAYLAR

Medicines like VRAYLAR start working gradually, so you may not see results right away. Every patient is different so it is important that you talk to your healthcare provider about how VRAYLAR is working for you. Don’t stop taking VRAYLAR without speaking to your healthcare provider first.

It is important that you stay on track with your VRAYLAR treatment. To help you remember to take your medication set reminders or keep a daily diary of your treatment.

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See if you’re eligible to save on your VRAYLAR prescription

SIDE EFFECTS

Knowing what to expect with treatment is important. Make sure to talk with your healthcare provider about the possible risks and side effects of VRAYLAR. The most common side effects of VRAYLAR in clinical trials were:

  • Uncontrolled movements of the body and face
  • Stiff muscles
  • Restlessness

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of VRAYLAR.

LEARN ABOUT SCHIZOPHRENIA

FAQs

VRAYLAR® (cariprazine) is approved for the treatment of schizophrenia in adults
Medical researchers believe that schizophrenia may be caused by an imbalance of certain chemicals in the brain called neurotransmitters. VRAYLAR is thought to affect the activity of neurotransmitters. However, the exact way VRAYLAR works is unknown.

Before taking VRAYLAR, make sure your healthcare provider knows about any medical conditions and if you have or have had:

  • Diabetes or high blood sugar in you or your family
  • High levels of cholesterol, triglycerides, or LDL-cholesterol; or low levels of HDL-cholesterol
  • Seizures or conditions that increase your risk for seizures
  • Low or high blood pressure
  • Low white blood cell count

Tell your healthcare provider if you are pregnant or plan to become pregnant. Using VRAYLAR in the third trimester may cause uncontrolled movements of the body and the face, muscle stiffness, or feelings of restlessness and/or withdrawal symptoms in newborn babies. A special program (National Pregnancy Registry for Atypical Antipsychotics) collects information on the safety of antipsychotic drugs, including VRAYLAR, during pregnancy. For information, contact the program at 1-866-961-2388 or http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

Tell your healthcare provider about all medicines that you take or have recently taken. This includes prescriptions, over-the-counter medicines, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works.

VRAYLAR is an oral capsule that is taken 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 so 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 were uncontrolled movements of the face and body, muscle stiffness, and restlessness. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all possible side effects of VRAYLAR.

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 with VRAYLAR. In 6-week clinical studies, patients with schizophrenia who took VRAYLAR experienced an average weight gain of about 2.2 pounds, compared to those on placebo who gained about 0.7 pounds

An increase in blood sugar has been reported with VRAYLAR. If you have diabetes or risk factors for diabetes (eg, being overweight or family history of diabetes), your blood sugar should be tested before you start VRAYLAR and regularly during treatment. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have symptoms such as feeling very thirsty or very hungry, urinating more than usual, or feeling weak

An increase in cholesterol has been reported with VRAYLAR. Your healthcare provider should check your cholesterol and triglyceride levels before and during treatment.

In the 6-week clinical study, 7% of patients with schizophrenia who took VRAYLAR felt sleepy or drowsy. In comparison, 6% of patients taking placebo felt sleepy or drowsy.

Feeling restless (akathisia) has been reported with VRAYLAR. In the 6-week clinical studies, 11% of patients with schizophrenia who took VRAYLAR felt restless.

Schizophrenia is a chronic condition. That means it’s lifelong and there is no cure. But for many people, the symptoms may be helped with treatment.

Schizophrenia is seen more often in people with a sibling or parent (a first-degree relative) who have the condition.

You may be eligible for a VRAYLAR savings card. Click here to learn more.

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IMPORTANT RISK 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.

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 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): Tell your healthcare provider if you cannot control the movements of your face, tongue, or other body parts. These could be signs of a serious and sometimes permanent side effect called TD. Risk of developing TD and the chance that it will become permanent are thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop even after a person has been taking the medicine for a short time at low doses. TD may partially or completely go away if you stop taking VRAYLAR. TD 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. Complications of diabetes can be serious and even life threatening. 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

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. Using VRAYLAR in the third trimester may cause uncontrolled movements of the body and face, muscle stiffness, or feelings of restlessness and/or withdrawal symptoms in newborn babies. If you become 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, and indigestion.

These are not all possible side effects of VRAYLAR.

INDICATION AND USAGE

VRAYLAR (cariprazine) is a once-a-day pill, taken with or without food, for the treatment of schizophrenia in adults.

Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide.

IMPORTANT RISK 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.

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 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): Tell your healthcare provider if you cannot control the movements of your face, tongue, or other body parts. These could be signs of a serious and sometimes permanent side effect called TD. Risk of developing TD and the chance that it will become permanent are thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop even after a person has been taking the medicine for a short time at low doses. TD may partially or completely go away if you stop taking VRAYLAR. TD 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. Complications of diabetes can be serious and even life threatening. 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

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. Using VRAYLAR in the third trimester may cause uncontrolled movements of the body and face, muscle stiffness, or feelings of restlessness and/or withdrawal symptoms in newborn babies. If you become 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, and indigestion.

These are not all possible side effects of VRAYLAR.

INDICATION AND USAGE

VRAYLAR (cariprazine) is a once-a-day pill, taken with or without food, for the treatment of schizophrenia in adults.

Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide.