DDG

Symptoms
In the past two weeks, I've been experiencing the following depression symptoms:
• Altered sleeping patterns (sleeping too much or too • Lack of energy or motivation for simple daily activities
little) such as taking a shower or getting dressed
• Impact on eating habits (eating too much or too little)
Lately, I've also been experiencing the following symptoms:
• Persistently increased energy • Unusually talkative

• Decreased need for sleep (eg, feeling rested after • Racing thoughts
only 3 hours of sleep) • Easily distracted (too easily drawn to unimportant or
irrelevant things)
It's important to talk with your healthcare provider about how you have been feeling.
Currently taking treatment? Notes

No
It's important to talk to your healthcare provider about all of

the medications you are currently taking. Use this time to
bring up how you are feeling.
Treatment considerations
I have the following concerns about treatment:
• Symptom relief
Now is the time to raise any questions or concerns you have about treatment with your healthcare provider.
INDICATIONS AND USAGE

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 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.
Please see additional Important Safety Information for VRAYLAR on pages 2 and 3.
Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide.
Some additional questions to consider asking your healthcare provider
The following are some of the most frequently asked questions about VRAYLAR (cariprazine):
• Could VRAYLAR be right for me? • Will I gain weight while on VRAYLAR?
• What are the possible side effects of taking • Can I anticipate any sexual side effects when taking
VRAYLAR? VRAYLAR?
• How does VRAYLAR work? • Could other medications I'm taking affect how
• When does VRAYLAR start to work? VRAYLAR works?
IMPORTANT SAFETY INFORMATION CONTINUED

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).
IMPORTANT SAFETY INFORMATION CONTINUED
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.
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.
US-VRAA-230152
LICENSED FROM GEDEON RICHTER PLC.
© 2023 ABBVIE COMPANY. ALL RIGHTS RESERVED.

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Symptoms

Lately, I've also been experiencing the following symptoms:

• Persistently increased energy • Unusually talkative

Currently taking treatment? Notes

It's important to talk to your healthcare provider about all of

INDICATIONS AND USAGE

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION CONTINUED

Who should not take VRAYLAR?

What are the most common side effects of VRAYLAR?

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