Vraylar (Cariprazine): Uses, Dosage, Side Effects, & More

What Is Vraylar (Cariprazine)?

Vraylar is an atypical second-generation antipsychotic medication. For some people, Vraylar may help improve mood, behaviors, and overall well-being. It’s believed that Vraylar works by affecting the activity of certain brain chemicals, serotonin, and dopamine.

Vraylar may help improve symptoms such as spasms, muscle contractions, and irregular movements more effectively than first-generation antipsychotics. For this reason, second-generation antipsychotics are used more often for these symptoms.

Vraylar is FDA-approved for the treatment of schizophrenia, bipolar disorder, and major depressive disorder (MDD) in adults. It has not been indicated for children or adolescents. FDA approval means the medication is proven to be safe and effective through clinical trials to treat specific conditions.¹

Is Vraylar a Mood Stabilizer or Antipsychotic?

Vraylar belongs to a class of drugs known as antipsychotics but also shares some features of mood stabilizers. Typically, mood stabilizers are used to prevent future mania or depression episodes in bipolar disorder. Vraylar shares some of these attributes of mood stabilizers but does not work in the same way antidepressants work. Other medications known for stabilizing mood in these manic episodes, like lithium, do not work the same as Vraylar.¹

Is Vraylar the Same as Abilify?

Vraylar is similar to Abilify as it is from the same class of medications, second-generation antipsychotics. Vraylar has the active ingredient, cariprazine, while Abilify contains aripiprazole. The two drugs offer a similar safety and effectiveness profile along with shared FDA uses for mental health conditions.

The main difference in treatment uses stems from Abilify having FDA approval in pediatric populations for schizophrenia and Tourette’s syndrome. Vraylar, however, does not have approval for this age group. Neither Ability nor Vraylar have FDA approval for the treatment of depression in pediatric patients.

Abilify has been shown to have a unique side effect called compulsive behaviors. People taking Abilify may do activities like gambling, shopping, or eating in compulsive ways, which may be harmful. Vraylar has not been linked with compulsive behaviors.

Both Abilify and Vraylar contain a boxed warning (the most serious FDA warning) for elderly patients with dementia-related psychosis having an increased risk of death. Additionally, Abilify is formulated as a tablet, and Vraylar is made as a capsule.^1,2

Different medications can work differently in people. It’s important to discuss what the most appropriate medication is and why with a healthcare professional.

Is Vraylar the Same as Seroquel?

Vraylar is similar to Seroquel as they both come from the same class, second-generation antipsychotics. They are both utilized to treat similar mental health conditions. Seroquel may be used in pediatric populations depending on the indication, but Vraylar is not. Seroquel also has multiple off-label uses beyond depression, schizophrenia, and bipolar.

Vraylar is designed to release the medication slowly over time, whereas Seroquel has a shorter response time in a formulation known as immediate release, This allows Seroquel to then be used for additional symptoms like agitation. Seroquel has more sedating effects compared to Vraylar but shares an overall similar side effect profile. ^1,3

Different medications can work differently in people. It’s important to discuss what the most appropriate medication is and why with a healthcare professional.

How Does Vraylar Work?

The primary mechanism of action for Vraylar is unknown. However, it is thought that it works by involving several nerve pathways in the brain, affecting the activity of dopamine and serotonin in the brain. This activity may help reduce and stabilize symptoms of schizophrenia, bipolar disorder, and depression.¹

How Does Vraylar Make You Feel?

The specific effects of Vraylar can vary for each individual. In general, Vraylar may help stabilize mood and improve symptoms relating to the condition. Some people might say they are feeling an improvement in recent emotional stability or have a reduced sense of anxiety. This feeling of improvement may come from having fewer mood swings and staying more focused, leading to less anxiety overall.¹

What Is Vraylar Used to Treat?

Vraylar is used to treat bipolar disorder, schizophrenia, and major depression. Vraylar is not used alone when treating depression.

Vraylar can be used as maintenance therapy, a treatment used to manage symptoms over a period of time, for schizophrenia and depressive episodes associated with bipolar disorder. These are FDA-approved uses, meaning that research and clinical trials demonstrate the safety and effectiveness of Vraylar in specific populations. Vraylar has shown variable side effects, and is not uncommon to see one antipsychotic discontinued with another one soon in its place.

A prescriber may choose to use Vraylar off-label. An off-label use of a medication is a use that is not FDA-approved. Prescribers can decide to use a medication because, in their professional judgment, they believe it may offer a benefit to someone. It’s important to keep in mind that if a medication is used off-label, insurance may not pay for that medication.¹

Common Side Effects of Vraylar

Vraylar may cause common side effects such as dizziness, insomnia, tremors, and constipation. Some initial adjustment effects may fade away after a few days and do not require medical attention. However, side effects due to the direct action of the medication often persist as long as the person takes it.

Vraylar may increase the risk of falls with the potential side effect of orthostatic hypotension (quick lowering of blood pressure upon changing position). Stay aware of any worsening of symptoms, as some can progress to much more serious problems. If any of these symptoms lead to uncontrollable movements, irregular heartbeat, or severe changes in mental status, it is important to seek medical attention right away.¹

Common side effects of Vraylar include:*¹

• Dizziness
• Difficulty moving/slow movements
• Tremors
• Sleepiness
• Increased appetite
• Nausea
• Restlenesses

*All medications, including Vraylar, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor and pharmacist about any questions you have and to understand the potential side effects and benefits of any medication.

Serious Side Effects of Vraylar

Serious side effects from Vraylar may occur and require immediate medical care. Symptoms relating to an irregular heartbeat, uncontrollable movements, or any degree of altered mental status are all serious side effects.¹

Serious side effects of Vraylar include:*¹

• Increased risk of suicidal thoughts
• Confusion and issues
• Severe dizziness
• Changes in your breathing, heart rate, or blood pressure
• High fever
• Stiff muscles
• Feeling very thirsty
• Muscle weakness

*All medications, including Vraylar, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor and pharmacist about any questions you have and to understand the potential side effects and benefits of any medication.

Vraylar Warnings & Precautions

Vraylar carries a boxed warning (the most serious FDA warning) associated with an increased risk of death in elderly patients with dementia-related psychosis. Vraylar has an additional boxed warning showing an increase in suicidal thoughts and behaviors in pediatric patients. These and other warnings refer to serious effects that are rare but require immediate medical care¹

Avoid taking Vraylar if you have:¹

• Neuroleptic malignant syndrome: This serious effect is rare but can be fatal. Signs of this condition include muscle stiffness, autonomic instability, and delirium (altered mental status).
• History of “seizures”: Vraylar may cause seizures but shows greater risk for patients who have conditions associated with seizures. This is more prevalent in elderly patients or people who are taking seizure medications.
• Been diagnosed with dementia: The FDA has issued a boxed warning for Vraylar for individuals with dementia as it may increase the risk for suicidal thoughts and behaviors in patients with dementia. Vraylar should never be given to this patient population.
• Body temperature dysregulation: Atypical APs may lower the body’s ability to reduce the core temperature. Strenuous exercise, extreme heat, or dehydration are all causes of increased body temperature, and should use caution when on Vraylar.
• History of “low white blood cell count”: Patients who have been told they have low white blood cells or have experienced leukopenia/neutropenia should be closely monitored.
• Orthostatic hypotension and syncope: The risk of a sudden change of blood pressure when changing position is higher when initiating or increasing the dose of Vraylar and should be monitored.
• Late occurring adverse reactions: Vraylar stays in the body for a long time, which can cause adverse side effects to occur later than normally expected with other medications. Side effects can be seen several weeks after starting or discontinuing this medication.
• Tardive dyskinesia: Tardive dyskinesia is a potentially irreversible side effect that causes repetitive movements in the patient’s face, neck, tongue, and extremities. The risk of this side effect becoming irreversible increases as the person continues to take the medication.

Vraylar Dosages for FDA-Approved Treatment

Vraylar doses can vary widely based on factors such as age, the indication being used to treat, and the overall patient’s response to the medication. The primary assessment for dosage is the condition Vraylar is being used to treat.

Vraylar is approved for use in adults 18 years and older. The recommended starting dose for any condition is 1.5 mg. After this, the dosage may be increased according to how the person responds. For schizophrenia and bipolar mania, the recommended maximum dose is 6 mg daily. Vraylar can be used for bipolar depression or as an adjunctive (add-on) therapy to antidepressants for major depression. When used for bipolar or major depression, Vraylar’s daily maximum dose is 3 mg.¹

Vraylar Forms & Strengths

Vraylar is only available as a brand name medication and comes in one formulation as an oral capsule in four strengths. The major criteria prescribers consider when choosing between strengths come from patient-specific factors and the health condition being treated.

Vraylar is available in oral capsules, and it is an extended-release medication. This means that the medication is slowly released into the body over time. Extended-release formulations allow for once-daily dosing, which can be more convenient for patients.

Dosages of Vraylar can vary based on several factors, including the condition being treated, individual patient response, and the presence of any other medical conditions. The initial dosage is often lower and gradually increased to achieve the desired therapeutic effect while minimizing side effects.

It is important to follow the prescribed dosing schedule and give the medication time to work. Typically, improvements in symptoms may be observed within a few weeks of starting Vraylar.¹

Vraylar is available in the following forms and strengths:¹

• 1.5 milligram (mg) oral capsule
• 3 mg oral capsule
• 4.5 mg oral capsule
• 6 mg oral capsule

How Should I Take Vraylar?

Vraylar should be taken as directed by your healthcare provider. Vraylar is dosed once a day, can be taken with or without food, and should be taken at a consistent time each day. Do not stop or increase the dose of Vraylar unless your prescriber has advised you to. Otherwise, you may experience unwanted side effects. If you have taken too much of your Vraylar at once, go to the nearest emergency room or call your prescriber immediately.¹

What Happens If I Miss a Dose of Vraylar?

Take the missed dose as soon as you remember. However, if it is close to the time for the next dose, wait to take that dose at the specified time. Do not double the dose of Vraylar. If doses are consistently missed, this may cause serious side effects to occur.¹

Can You Overdose on Vraylar?

Yes, you can overdose on Vraylar, although this is uncommon. Vraylar overdose symptoms may include irregular heartbeat, orthostatic hypotension, or increased fatigue. It is important to take Vraylar directly how your healthcare provider prescribes the medication.¹

What Should You Do If You Take Too Much Vraylar?

If you take too much Vraylar, contact your prescriber or seek medical care immediately. If you go to the nearest emergency room, the healthcare team will provide supportive care and monitor you for any worsening signs.¹

What to Avoid When Taking Vraylar

Vraylar can have harmful interactions with other medications. Mild side effects like dizziness can put certain patients more at risk for falls than others. Impairment of motor skills can also be an additional risk when taking this medication. Do not become too hot or dehydrated when taking Vraylar, as it can have a negative impact on your body’s ability to regulate your temperature.¹

3 substances you should avoid while taking Vraylar include:

• Alcohol: Alcohol may increase the side effects of Vraylar, like dizziness and decreased motor functions. This can cause irritability and impaired judgment.
• CYP3A4 inhibitors (e.g. ketoconazole): Medications under this class can increase the levels of Vraylar in your body, which could increase side effects and toxicity. Vraylar dosage should be decreased to reduce this risk.
• CYP3A4 inducers (e.g. St. John’s Wort, carbamazepine): These substances may be used to treat symptoms of depression. However, the impact of using Vraylar and CYP3A4 inducers is not well understood, and using them together is not recommended.

This is not a comprehensive list of the possible interactions with Vraylar. You should talk with your healthcare provider and your pharmacist about all prescription and over-the-counter medications, herbs, and supplements you take before starting Vraylar.

How to Get a Prescription for Vraylar

Vraylar is a prescription-only medication. A physician, nurse practitioner, physician assistant, or psychiatrist are a few who can prescribe this medication. The provider will conduct a thorough examination of your medical history, symptoms, and psychological needs before choosing a treatment. The provider will assess the overall risks and benefits of prescribing Vraylar.¹ Finding a psychiatrist may be necessary if you are looking for a new prescriber.

Questions to Ask Your Healthcare Provider About Vraylar

Patients should have an understanding of precautions and general side effects before starting this medication. This should be addressed through shared decision-making while discussing the overall risks and benefits of Vraylar. All antipsychotics have the potential to increase the risk of suicidal thoughts and behaviors.

Ask your doctor, psychiatrist, pharmacist, and therapist any questions about Vraylar you may have. Online psychiatry services are another good resource for patients who may wish to change providers.

Questions to ask your care team about Vraylar include:

• How safe is Vraylar?
• How long will it take for me to adjust to taking Vraylar?
• Am I at risk for more serious symptoms with Vraylar if I am already taking other medications?
• What is the best dosage of Vraylar to ensure fewer side effects?
• Will my insurance cover Vraylar?
• How much does Vraylar cost, and are there coupons available?
• What should I do if my pharmacy has a shortage of Vraylar?
• When do I need to reach out to you after starting Vraylar?
• Will Vraylar affect my blood sugar on a daily basis since I am a diabetic?
• What interactions does Vraylar have with my current medications?
• What happens if I forget to take my Vraylar?
• Coudl Vraylar be considered as an Abilify alternative?