VRAYLAR AND
SCHIZOPHRENIA

About Schizophrenia

Schizophrenia is a mental illness that can affect how clearly you think, how well you can relate to others, and how you handle your emotions.

Although there may be many factors, it is thought that schizophrenia may be caused by an imbalance of certain chemicals in the brain called neurotransmitters. Examples of neurotransmitters are dopamine and serotonin.

What are the symptoms of Schizophrenia?

There are different types of symptoms relating to your emotions, mood, and behavior. Knowing the symptoms of schizophrenia may help you better understand the illness.

Hallucinations

Seeing, hearing, smelling, or feeling things that others do not

Delusions

False beliefs that are not logical, such as paranoia (believing others are trying to harm you)

Disorganized thinking and actions

Thinking, speaking, and moving in ways that are not understood by others

Social withdrawal

Loss of interest in interacting with others

“Flat Affect”

Speaking in a dull voice without facial movement

Loss of pleasure

Lack of interest in participating in everyday activities or plans

Trouble processing information

Inability to understand information clearly or make decisions

Inability to focus

Easily distracted or trouble paying attention

Learning difficulties

Problems remembering new information

Does everyone with Schizophrenia have the same symptoms?

No, everyone with schizophrenia experiences its symptoms differently, so it is important to speak openly with your healthcare provider, caregiver, and support team to make sure your needs and concerns are being handled. The good news is that, although there is no cure for schizophrenia, there are a number of different treatments to help you manage your symptoms.

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 by mouth for the treatment of schizophrenia.

In 3 clinical studies, VRAYLAR was shown to help manage symptoms in adults with schizophrenia.

People who took VRAYLAR in these 6-week studies 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 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.

Ask your healthcare provider if VRAYLAR could help you take control of your schizophrenia.

How does VRAYLAR work?

Although the exact way VRAYLAR works is unknown, it is thought to affect the activity of neurotransmitters, which may be too high or too low.

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 schizophrenia 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
  • 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

About 9% of patients taking VRAYLAR and 12% of patients taking placebo stopped treatment due to side effects. Some patients stopped treatment because of worsening of their schizophrenia, for example, due to untreated illness. Of the patients given VRAYLAR, no single side effect led to stopping treatment at a rate of 2% or more and double the rate of placebo.

Will VRAYLAR have any effect on my weight?

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 pounds, compared to those on placebo who gained about 0.7 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.