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Vraylar – What’s It Used For, Benefits, Side Effects and More

Vraylar – What’s It Used For, Benefits, Side Effects and More

Vraylar (pronounced vrāy-lar) is a brand name for a new drug recently approved by the United States Food and Drug Administration (US FDA) to treat adults with the mental disorders known as schizophrenia or bipolar disorder. Approximately 2.6 million patients in the US suffer from schizophrenia and 1 million more or 3.6 million suffer from bipolar disorder. It has been estimated that as many as 51 million people worldwide suffer from schizophrenia and 60 million suffer from bipolar I disorder.  

In September 2015, Vraylar was approved by the US FDA for the acute treatment of schizophrenia and the acute treatment of manic or mixed episodes in people with bipolar disorder type I. Two years later, in November 2017, Vraylar was approved in the US for the maintenance treatment of adults with schizophrenia. In July 2017, the European Commission granted an authorization to market the active ingredient in Vraylar (cariprazine) under the brand name Reagila®.

What Is Vraylar?

Vraylar was approved by the US FDA in 2015 to treat adults with the mental disorders known as schizophrenia or bipolar disorder. It was additionally approved in 2017 for use as a maintenance treatment for adults with schizophrenia. It is not approved for anyone under 18 years of age.

Vraylar is available in four different dosages as a gelatin-coated capsule to be taken orally. The active ingredient in Vraylar is cariprazine hydrochloride, or cariprazine as it is more commonly called. It’s an antipsychotic medication that affects chemicals known as neurotransmitters such as dopamine and serotonin in the brain. It's not known exactly how Vraylar works, but it is thought to help even out the amount of neurotransmitters. Vraylar is not a controlled substance,

The drug belongs to the drug class known as atypical antipsychotics or second-generation antipsychotics. Although less expensive, first-generation antipsychotics are known to have considerable side effects. This means drugs like Vraylar are becoming preferred by doctors because of the potential for fewer and less serious side effects.

Vraylar Dosages

Vraylar is an oral medication available in gelatin-coated capsules at four different dosages: 1 mg, 3 mg, 4.5 mg, and 6 mg. Each capsule contains specific milligrams of a white to off-white powder.  Capsules are packaged most often in 30-day and 90-day supplies.

The 1 mg capsule is a white color, and it is imprinted with FL-1. The 3 mg capsule is a green and white color, and it is imprinted with FL-3.  The 4.5 mg capsule is half green and half white and is imprinted with FL-4.5.  The 6 mg capsule is a half purple and half white and is imprinted with FL-6.

Regardless of the dose being taken, the medication should be taken once a day and can be taken with or without food.

The starting dose of 1 mg is recommended to treat both schizophrenia and bipolar I disorder. Following the starting dose, 1.5 mg to 6 mg per day is recommended for schizophrenia patients and 3 mg to 6 mg per day for bipolar I disorder. Risks increase above 6 mg per day with no observable increase in benefits.

Vraylar Metabolism

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Just as any drug has its own unique benefits and side effects, each drug also has its own metabolism, or half-life.  The half-life of a drug is the time it takes for the drug to be removed from your bloodstream after being metabolized by your liver and kidneys. Vraylar has a long half-life. This means it may take several months before patients see positive benefits for their symptoms. This also means patients will continue to experience the benefits of Vraylar for several months after stopping the medication. You should not stop taking the medication without first discussing it with your doctor.

Vraylar Access & Affordability

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Vraylar is included on most, if not all, Medicare Part D, State Medicaid, State Health Exchange, Managed Medicaid, and commercial drug formularies. Vraylar also has a savings program, called VRAPAY.  Eligible patients will pay as little $15 for each 30-day prescription filled, up to 12 fills.  Be sure to read the VRAPAY program terms, conditions, and eligibility criteria carefully.  For example, cash-paying patients and patients that are Medicare-eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees are not eligible for the VRAPAY Vraylar savings program. There are others who may also not be eligible.

As with any new drug that does not have a generic version available, the cost can be quite expensive.

What Symptoms Does It Treat?

Vraylar is used to treat the symptoms of two mental or brain disorders–schizophrenia and bipolar I disorder. Patients with schizophrenia also need maintenance or long-term treatment options and Vraylar meets this need.

Schizophrenia Symptoms

Bipolar I Disorder Symptoms

Benefits & Effects

Black Box Warning


Schizophrenia and bipolar disorder, if left untreated, can result in severe problems that can greatly interfere in every area of a person’s life. Thankfully, new drugs are being discovered by pharmaceutical companies to help people be able to live somewhat of a normal life. Vraylar is one of these new drugs that are now available to help over 6 million US patients suffering from schizophrenia and bipolar 1 disorder manage their day-to-day activities.

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