VRAYLAR Uses & Important Safety Info

VRAYLAR Uses & Important Safety Info | See abbv.ie/vraylarPI

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Side Effects

Subscribers

Please see full Prescribing Information, including BOXED WARNINGS & Medication Guide at https://abbv.ie/vraylarPI

Watch to learn more about the Uses and Important Safety Information for VRAYLAR (cariprazine).

INDICATION AND USES

VRAYLAR is a prescription medicine used in adults:

- along with antidepressant medicines to treat major depressive disorder (MDD)
- for short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder
- to treat depressive episodes that happen with bipolar I (bipolar depression)

*IMPORTANT SAFETY CONSIDERATIONS*

*VRAYLAR may cause serious side effects, including:*

- *Elderly people with dementia-related psychosis have increased risk of death or stroke. VRAYLAR is not approved in elderly patients with dementia-related psychosis.*
- *Tell your doctor about unusual changes in behavior or suicidal thoughts. VRAYLAR and antidepressants may increase suicidal thoughts and actions in some children and young adults, especially in the first few months of treatment or when the dose is changed. VRAYLAR is not approved for people under 18 years of age.*
- Seek medical help right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS), a rare but potentially fatal side effect.
- VRAYLAR may cause uncontrolled body movements (tardive dyskinesia or TD) in your face, tongue, or other body parts, which may be permanent.
- VRAYLAR may cause problems with your metabolism, including increased cholesterol or triglycerides, weight gain, high blood sugar, and diabetes. Extremely high blood sugar can lead to coma or death.
- VRAYLAR may also cause low white blood cell count, decreased blood pressure, falls, seizures (convulsions), sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities, increased body temperature, and difficulty swallowing.

*Do not take VRAYLAR if you are allergic to any of its ingredients.*

*The most common side effects of VRAYLAR 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.

Some side effects may happen a few weeks after starting VRAYLAR or if your dose increases. You and your doctor should monitor, discuss, and report any adverse events if they occur.

These are not all the possible side effects of VRAYLAR. Visit VRAYLAR.com to learn more.

For additional Important Safety Information, visit https://abbv.ie/VraylarISI

US-VRAA-230147

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