Vraylar

Generic name: Cariprazine
Dosage form: capsules (1.5mg, 3mg, 4.5mg, 6mg)
Drug class: Atypical antipsychotics

Usage of Vraylar

Vraylar (Cariprazine) is used to treat types of bipolar I disorder, major depressive disorder (MDD), and schizophrenia. Vraylar works to improve depression symptoms in bipolar depression and major depressive disorder and to improve psychiatric signs and symptoms in schizophrenia. Vraylar capsules are taken once a day.

Vrylar is thought to work by managing serotonin and dopamine levels, which are chemical messengers in the brain. Vrylar is thought to have this effect (mechanism of action) by having a combination of partial agonist activity at central dopamine D₂ and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors. Vraylar is from the drug class of medications called atypical antipsychotics.

Vraylar originally became an FDA-approved medicine on September 17, 2015. Vraylar has FDA approval to treat adults with:

schizophrenia

acute manic or mixed episodes associated with bipolar I

depressive episodes associated with bipolar I disorder (bipolar depression)

major depressive disorder (MDD) as an add-on treatment with an antidepressant therapy (ADT).

Vraylar side effects

Common Vraylar side effects may include sleepiness, nausea, vomiting, indigestion, constipation, feeling tired, trouble sleeping, increased appetite, dizziness, involuntary muscle movements, feeling restless, upset stomach, difficulty moving, or slow movements.

Vrylar may cause weight gain. You and your healthcare provider should check your weight before you start and often during treatment.

Serious Vraylar side effects

Get emergency medical help if you have signs of an allergic reaction to Vraylar, including hives, difficulty breathing, and swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

sudden numbness or weakness (especially on one side of the body);

problems with vision or speech,

a light-headed feeling, like you might pass out;

severe distress or agitation;

a seizure;

uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking, or eye movement);

trouble swallowing or accidentally inhaling food or drink;

low white blood cell counts - fever, chills, sore throat, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed;

high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or

severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Vraylar can have long-lasting effects on your body. Some side effects could occur for several weeks after you stop using this medicine. You may also have new side effects whenever your dose is changed.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Vraylar

You should not use Vraylar if you are allergic to cariprazine.

Vraylar is not approved for use by anyone younger than 18 years old.

Cariprazine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Vraylar is safe for you, tell your doctor if you have:

heart disease, high blood pressure;

a stroke or blood clot;

high cholesterol or triglycerides (a type of fat in the blood);

liver or kidney disease

diabetes or high blood sugar, or a family history of diabetes or high blood sugar

have or had a low white blood cell count

have or had seizures (convulsions)

if you are dehydrated

Taking antipsychotic medicine in the last 3 months of pregnancy may cause withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking Vraylar without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cariprazine on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

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How to use Vraylar

Take Vraylar once a day, with or without food.

General Vraylar dose information.

It may take several weeks before your symptoms improve. Keep using the medication as directed, and tell your doctor if your symptoms do not improve.

Take Vraylar exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

High doses or long-term use of Vraylar can cause a serious movement disorder that may not be reversible. The longer you use this medicine, the more likely you are to develop this disorder, especially if you are an older adult. Symptoms of this disorder include tremors or other uncontrollable muscle movements.

Tell your doctor if you have any changes in weight while taking this medicine.

Your blood pressure and heart rate will need to be checked often. You may also need frequent blood tests.

Vraylar capsules are available as 1.5 mg, 3 mg, 4.5 mg, and 6 mg.

Warnings

Vraylar is not approved for use in older adults with dementia-related psychosis.

Vraylar may disrupt the body’s ability to reduce core body temperature. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may cause an increase in body temperature. Use this medicine with caution in these circumstances.

Vraylar and antidepressant medicines 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.

What other drugs will affect Vraylar

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Taking Vraylar with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with cariprazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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