Vraylar

Conditions Treated

Vraylar is an atypical antipsychotic medication approved for use in adults to manage symptoms of specific mood and mental health disorders.

Schizophrenia

It is used for the treatment of schizophrenia, a chronic condition that can affect how a person thinks, feels, and behaves. It helps manage symptoms such as hallucinations, delusions, and social withdrawal.

Bipolar I Disorder

Vraylar is used to treat different types of episodes associated with bipolar I disorder:

• Manic or mixed episodes: It is used for the short-term treatment of acute manic or mixed episodes, which are characterized by periods of abnormally high energy, impulsivity, or irritability.
• Depressive episodes: It is used to treat depressive episodes, often referred to as bipolar depression, which involve periods of intense sadness, low energy, or loss of interest in activities.

Major Depressive Disorder

Vraylar is also approved as an adjunctive (add-on) treatment for adults with major depressive disorder (MDD). In this situation, it is prescribed to be taken along with a primary antidepressant medication when the antidepressant alone has not sufficiently improved symptoms.

Mechanism of Action

The exact way Vraylar works in the brain is not fully understood. However, researchers believe it helps manage symptoms by affecting the activity of two primary chemical messengers, or neurotransmitters: dopamine and serotonin.

Vraylar is thought to work in the following ways:

• Dopamine regulation: It acts as a partial agonist at specific dopamine receptors (D3 and D2). This means it can either increase or decrease dopamine activity depending on the levels already present in the brain, helping to stabilize mood and behavior.
• Serotonin regulation: It also interacts with serotonin receptors (5-HT1A and 5-HT2A). By influencing these receptors, the medication helps regulate mood, sleep, and appetite.

Unlike some other medications, Vraylar and its active components stay in the body for a long time. This long-lasting effect helps maintain a steady level of the medicine in the system, though it may also mean it takes several weeks to reach its full effect or for the drug to completely leave the body after the last dose.

Common Side Effects

Many people taking Vraylar experience mild to moderate side effects. These may include:

• Restlessness: An urgent need to move or inability to sit still (akathisia).
• Movement issues: Tremors, muscle stiffness, or slow body movements.
• Digestive problems: Nausea, vomiting, indigestion, or constipation.
• Sleepiness: Feeling unusually tired or drowsy.
• Dizziness: Feeling lightheaded, especially when standing up.
• Weight gain: Changes in body weight are common with this medication.
• Blurred vision: Temporary changes in eyesight.

Serious Side Effects

While less common, some side effects require immediate medical attention. These include:

• Tardive dyskinesia: Uncontrolled, repetitive movements of the face, tongue, or other body parts. This condition can sometimes become permanent.
• Neuroleptic Malignant Syndrome (NMS): A rare but life-threatening reaction that causes high fever, stiff muscles, confusion, and sweating.
• Metabolic changes: High blood sugar (hyperglycemia), which may cause extreme thirst or frequent urination, and increases in cholesterol or triglycerides.
• Low white blood cell count: A decrease in the cells that fight infection, which may lead to fever or frequent illness.
• Difficulty swallowing: This can lead to food or liquid entering the lungs (aspiration).
• Seizures: An increased risk of convulsions in some patients.
• Temperature regulation issues: Difficulty cooling down after heavy exercise or exposure to high heat.
• Orthostatic hypotension: A sudden drop in blood pressure when rising from a sitting or lying position, which may cause fainting.

Boxed Warnings

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Vraylar is not approved for the treatment of patients with dementia-related psychosis.

In clinical trials, some children, adolescents, and young adults taking antidepressants or related medications experienced an increase in suicidal thoughts and behaviors. Monitoring for any changes in mood, behavior, or suicidal ideation is important.

Serious Side Effects

• Neuroleptic Malignant Syndrome (NMS): This is a rare but life-threatening reaction. Signs include high fever, stiff muscles, confusion, and sweating.
• Tardive Dyskinesia: Long-term use may cause involuntary muscle movements, often in the face or tongue. This condition may become permanent.
• Late-Occurring Adverse Reactions: Because Vraylar stays in the body for a long time, side effects may not appear until several weeks after starting the medication or changing the dose.

Metabolic and Physical Changes

Vraylar may cause metabolic issues, such as high blood sugar, diabetes, increased fat levels in the blood, and weight gain. Healthcare providers typically monitor weight and blood sugar levels during treatment.

Other risks include a decrease in white blood cell counts, which can increase the risk of infection. Patients may also experience orthostatic hypotension, which is a sudden drop in blood pressure upon standing that can cause dizziness or fainting.

General Precautions

• Seizures: Use with caution in individuals with a history of seizures.
• Cognitive Impairment: The drug may cause drowsiness or affect judgment and motor skills. Caution is advised when driving or operating heavy machinery.
• Body Temperature: This medication can make it harder for the body to cool down. It is important to avoid becoming overheated or dehydrated during exercise or in hot weather.

Pregnancy

It is not known if Vraylar will harm an unborn baby. However, taking antipsychotic medications like Vraylar during the third trimester of pregnancy may cause problems in the newborn after delivery. These issues can include withdrawal symptoms, breathing problems, feeding difficulties, tremors, and muscle stiffness or weakness.

If you become pregnant while taking Vraylar, do not stop taking the medication without first consulting your doctor. Suddenly stopping an antipsychotic can cause a relapse of symptoms or other medical issues. There is a pregnancy registry available to monitor the health of individuals and their babies who are exposed to antipsychotic medications during pregnancy.

Breastfeeding

It is currently unknown if Vraylar passes into human breast milk or how it might affect a nursing infant. Because many drugs are excreted in human milk and there is a potential for serious adverse reactions in nursing infants, you should talk to your healthcare provider to decide whether to breastfeed or continue taking the medication.

Available Forms

Vraylar is supplied as capsules for oral administration. These capsules are intended to be swallowed whole and are available in several different strengths to allow for dosage adjustments by a healthcare provider.

FDA Approval and Indications

Vraylar (cariprazine) was first approved by the FDA in September 2015. It is currently approved for use in adults for the following conditions:

• Schizophrenia.
• Acute treatment of manic or mixed episodes associated with bipolar I disorder.
• Depressive episodes associated with bipolar I disorder (bipolar depression).
• Adjunctive (add-on) treatment for major depressive disorder (MDD).

Boxed Warning

The FDA requires a boxed warning for Vraylar, which is its most serious safety notification. This warning states that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. Vraylar is not approved for the treatment of patients with dementia-related psychosis.

Suicidal Thoughts and Behaviors

Because Vraylar is approved as an adjunctive treatment for major depressive disorder, it carries a warning regarding suicidal thoughts and behaviors. This risk is highest in children, adolescents, and young adults. While Vraylar is not approved for use in pediatric patients, the FDA advises that all patients starting antidepressant treatment be monitored closely for clinical worsening or unusual changes in behavior.

Regulatory History

Since its initial approval for schizophrenia and bipolar mania in 2015, the FDA has expanded Vraylar's approved uses. In 2019, it was approved for the treatment of depressive episodes associated with bipolar I disorder. In December 2022, the FDA approved Vraylar as an adjunctive therapy for the treatment of major depressive disorder in adults.

Managing Discontinuation

You should not stop taking Vraylar without first talking to your doctor. Stopping the medication suddenly can cause your condition to worsen or lead to a relapse of symptoms, such as mania, depression, or psychosis. If you and your doctor decide you should stop taking this medication, they will likely recommend gradually reducing your dose to help prevent these issues.

Long-Lasting Effects

Vraylar and its active components stay in your system for a long time. Because the drug has a long half-life, it can take several weeks for the medication to completely leave your body after your last dose. This means that while immediate withdrawal symptoms may be less common than with some other medications, any changes in your condition or potential side effects might not appear until weeks after you stop treatment.

When to Contact Your Doctor

If you experience new or worsening symptoms after stopping Vraylar, contact your healthcare provider immediately. They can help monitor your progress and ensure that the medication is discontinued safely. Do not attempt to taper the medication on your own without medical supervision.