VRAYLAR AND
BIPOLAR I DISORDER

Acute manic or mixed episodes in adults

About Bipolar I Disorder

Bipolar I disorder is a condition that causes unusual changes in mood, activity levels, energy, and the ability to carry out everyday tasks. Bipolar I disorder is also known as manic-depressive illness, and, although there is no known cure, its symptoms can be treated.

What are the symptoms of Bipolar I Disorder?

Although everyone has typical ups and downs, bipolar I disorder can cause these to be more extreme. If you are living with bipolar I disorder, you know more than anyone how it can affect you.

People diagnosed with bipolar I disorder have periods called “mood episodes,” which are severe changes from a person’s typical mood. Mood episodes can be manic, depressive, or mixed. For example, people experiencing an episode of mania may describe their symptoms as feeling overly joyful or energetic, while those having a mixed episode have symptoms of both mania and depression at the same time.

Knowing and understanding the symptoms of bipolar I disorder may help you better understand the illness.

Does everyone with Bipolar I Disorder have the same symptoms?

No, everyone with bipolar I disorder experiences its symptoms differently. This means everyone has different needs to consider when choosing a treatment plan. It is important that you keep open communication with your healthcare provider so that he/she knows how well your treatment is working for you or if a change in your treatment plan may be needed. The good news is that there are many treatment options that can help manage your symptoms, and your healthcare provider can help find the right one for you.

Talk to your healthcare provider to help determine what treatment is right for you.

Why VRAYLAR?

VRAYLAR (vrāy-lar) is an FDA-approved prescription medicine taken once a day for the acute treatment of manic or mixed episodes of bipolar I disorder.

In 3 clinical studies, VRAYLAR was proven to help manage manic symptoms in adults with bipolar I disorder.

In each of these 3-week studies, VRAYLAR showed significant improvement in overall manic symptoms compared to those who took a placebo (sugar pill). This means that their symptoms of manic or mixed episodes associated with bipolar I disorder were less severe than the symptoms of people who took placebo.

VRAYLAR also reduced 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 manic symptoms of bipolar I disorder and can be an important part of your treatment plan.

Ask your healthcare provider if VRAYLAR could help you take control of your acute manic or mixed episodes of Bipolar I disorder.

How does VRAYLAR work?

Medical researchers believe that bipolar I disorder 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 the exact way VRAYLAR works is unknown, it is thought to affect the activity of neurotransmitters such as dopamine and serotonin.

Taking VRAYLAR

  • VRAYLAR is an oral capsule that is taken as directed, 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 to your healthcare provider

VRAYLAR is an oral capsule available in 4 dosage strengths: 1.5 mg, 3 mg, 4.5 mg, and 6 mg, as shown here.

Capsule not shown actual size

Your healthcare provider will decide what dose is best for you. If you have any questions about VRAYLAR, speak to your healthcare provider.

Take by mouth

Once a day

With or without food

It is important that you stay on track with your VRAYLAR treatment. It may help to set reminders or keep a daily diary of your treatment to ensure you remember to take your dose as directed.

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, including prescriptions, over-the-counter medicines, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works.

Learn about additional Important Risk Information for VRAYLAR.

How do I know if vraylar is working?

Do not stop taking VRAYLAR if you don’t notice an improvement in your manic symptoms right away. Every patient is different, so it is important that you talk to your healthcare provider about how VRAYLAR is working for you.

Side effects of VRAYLAR

It is important for you to know about the possible risks and side effects of VRAYLAR.

The most common side effects were:

  • Uncontrolled movements of the face and body
  • Stiff muscles
  • Indigestion
  • Vomiting
  • Sleepiness
  • Restlessness

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

Discontinuations due to side effects

In the 3-week clinical studies, about 12% of patients taking VRAYLAR stopped treatment due to side effects versus 7% of patients who were taking a placebo (sugar pill).

Of the patients given VRAYLAR, the only side effect that led to stopping treatment at a rate of 2% or more and double the rate of placebo was feelings of restlessness (2%).

Will VRAYLAR have any effect on my weight?

Weight gain has been reported with VRAYLAR. In the 3-week clinical studies, patients with bipolar I disorder who took VRAYLAR experienced an average weight gain of up to 1.3 pounds, compared to those on placebo who gained about 0.4 pounds. Your healthcare provider should check your weight before and regularly during treatment.

If you are concerned about gaining weight, your healthcare provider may also recommend that you follow an exercise plan and keep a healthy diet. Speak with your healthcare provider if you have any questions about maintaining a healthy lifestyle.

Important Risk Information and Indications
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 antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for treating people with dementia-related psychosis.

VRAYLAR may cause serious side effects, including:
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:

Tell your healthcare provider if you are pregnant, or if you plan to become pregnant. 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. 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, including prescriptions, over-the-counter medicines, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works.

What are the most common side effects of VRAYLAR?

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.

Indications and Usage

VRAYLAR (cariprazine) is indicated in adults for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia.

Please see the Prescription Drug Facts and full Prescribing Information, including Boxed Warning.