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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.

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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.

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VRAYLAR (cariprazine) capsules 1.5mg • 3mg • 4.5mg • 6mg

Bipolar I Depression, Acute Mixed Episodes, Acute Mania

Individual results may vary.

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VRAYLAR can provide full-spectrum relief for all bipolar I disorder symptoms: bipolar I depression, acute mixed episodes, and acute mania.

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Let’s look inside the brain

Control center

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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.

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Norepinephrine

Serotonin

Dopamine

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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.

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Agonists

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Medications called agonists are thought to turn up activity related to specific chemicals.

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Antagonists

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Medications called antagonists are thought to turn down activity related to specific chemicals.

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How does VRAYLAR work?

Partial agonist

The exact way that VRAYLAR works is unknown.

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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?

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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.

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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.

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