VRAYLAR works to help control the mood swings of bipolar I disorder in adults, providing full-spectrum relief for all bipolar I symptoms: bipolar I depression and acute manic or mixed episodes.
Studies have shown VRAYLAR can:
*VRAYLAR was not studied to measure symptoms individually.
†At 3 weeks in 3 manic/mixed episode studies; at 6 weeks in 3 bipolar I depression studies.
‡Based on a specific research tool used by healthcare providers.
VRAYLAR is approved in adults to treat bipolar I depression and for the short-term treatment of manic or mixed episodes that happen with bipolar I disorder. While anyone can develop bipolar I disorder, it often starts in the late teen or early adult years and lasts a lifetime.
Since VRAYLAR was introduced in 2015, it has already been used by more than 600,000 people.*
Find an effective treatment plan that works for you. Read on >
*Inclusive of all VRAYLAR indications.
See Christine’s story with bipolar l disorder
Treatments like VRAYLAR start working gradually. Every patient is different. So, it’s important to talk to your healthcare provider about how VRAYLAR is working for you.
Take Once a Day
It’s important that you take your prescribed dose of VRAYLAR as directed, even if you start to feel better.
Take by Mouth
Do not stop taking VRAYLAR or change how much you take without checking with your healthcare provider first.
With or Without Food
Take VRAYLAR once a day, with or without food.
In clinical trials, the most common side effects were:
Patients taking VRAYLAR experienced changes in blood sugar and cholesterol similar to those who took a placebo. In 6-week and 8-week bipolar I depression studies, patients who took VRAYLAR experienced an average weight gain of 1.2 pounds, compared to those on placebo who lost 0.2 pounds. In 3-week bipolar I mania studies, patients who took VRAYLAR experienced an average weight gain of 1.1 pounds, compared to those on placebo who gained 0.4 pounds.
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.
Average weight change in 6- and 8-week bipolar I depression studies:
Average weight change in 3-week bipolar I mania studies:
§In clinical studies, 99% of patients in 3-week bipolar mania trials and 97% of patients in 6- and 8-week bipolar depression trials saw no substantial impact on weight (defined as ≥7% change).
Most common sexual adverse reactions across clinical studies.†
|
Placebo (n=468) |
VRAYLAR |
VRAYLAR |
|
Abnormal Orgasm |
0% |
0% |
0.4% |
|
Decreased Sex Drive |
0% |
0.2% |
0% |
|
Erectile Dysfunction |
0% |
0.6% |
0.9% |
|
Delayed Ejaculation |
0% |
0% |
0% |
†These adverse events were self-reported by patients.
Tips for Managing Bipolar I
Discover tips that may help
manage your bipolar I disorder
Discover tips that may
help manage your
bipolar I disorder
Bipolar I Support
Sign up for wellness support
from My Mood Matters
Sign up for wellness support
from My Mood Matters
Bipolar I Questionnaire
Take this quiz that could
help your doctor determine
whether you may have
bipolar I disorder
INDICATIONS 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
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:
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:
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.
INDICATIONS AND USAGE
VRAYLAR is a prescription medicine used in adults:
Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide.
US-VRAA-230239
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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