Vraylar dosage, forms, and strengths

Vraylar is a brand-name prescription antipsychotic drug approved for the treatment of schizophrenia and to help manage depression or manic episodes in people with bipolar I disorder. Cariprazine, the active ingredient in Vraylar, belongs to a family of drugs called atypical antipsychotics. These drugs help calm nerve activity in the brain but have a lower risk of causing movement disorders than earlier antipsychotics. Vraylar is taken as a capsule once per day with or without food.

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Vraylar forms and strengths

Vraylar is taken as a gelatin-coated capsule with four different dose strengths in 1.5 milligram (mg) increments:

• Capsules: 1.5 mg, 3 mg, 4.5 mg, 6 mg

Vraylar dosage for adults

Vraylar is used to treat schizophrenia and mood episodes (mania or depression) in people diagnosed with bipolar I disorder. The U.S Food and Drug Administration (FDA) has mandated a boxed warning on Vraylar, however, that treating elderly patients with dementia-related psychosis carries an increased risk of death. For all indications, the starting dose is 1.5 mg. Dosage adjustments are made in 1.5 to 3 mg increments until an effective dose is reached. However, the dose range will vary by indication.

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Sources: Epocrates

Vraylar dosage for schizophrenia

Schizophrenia is a psychiatric disorder in which people’s thoughts and perceptions do not completely correspond to reality. Symptoms include wrong perceptions (hallucinations), wrong ideas about the world (delusions), and scrambled thinking. Schizophrenia has many causes, but it is believed that an imbalance in brain chemicals called neurotransmitters is partly responsible for the disordered way the brain processes sensations and thoughts in people with schizophrenia. Some neurotransmitters that excite the brain, like dopamine, serotonin, and epinephrine, are hyperactive in people with schizophrenia and some neurotransmitters that calm the brain, such as GABA, aren’t active enough. Although its pharmacology is imperfectly understood, healthcare professionals believe cariprazine improves schizophrenia symptoms by blocking the nerve receptors that are sensitive to dopamine and serotonin, helping to restore more balanced nerve activity in the brain. 

• Standard dosage for schizophrenia in adults: 1.5–6 mg taken once daily

• Maximum dosage for schizophrenia in adults: 6 mg per day

Vraylar dosage for the acute treatment of bipolar mania or mixed episodes

Bipolar I disorder is a medical condition characterized by severe changes in mood, called mood episodes. People with bipolar I disorder cycle between depressive episodes and extremely high-energy episodes, called manic episodes. A mixed bipolar I episode occurs when patients experience both depression and mania at the same time. These mood episode cycles are hard to predict, and mood episodes can significantly interfere with daily activities and functioning. 

Vraylar helps manage the symptoms of manic episodes when they occur. Treatment will continue until sufficient improvement in symptoms is realized. Like schizophrenia, many of the symptoms of mania are due to hyperactivity in the brain. Cariprazine helps calm the brain by blocking dopamine and serotonin, two neurotransmitters responsible for heightened nerve activity. 

• Standard dosage for bipolar mania and mixed episodes in adults: 3–6 mg taken once daily

• Maximum dosage for bipolar mania and mixed episodes in adults: 6 mg per day

Vraylar dosage for bipolar depression

Vraylar effectively treats depression in people with bipolar I disorder. Its mechanism of action is uncertain, but scientists believe it has something to do with its unique properties in blocking dopamine. As an antidepressant, it is prescribed to people with bipolar I disorder because it also works against mania. Other antidepressants, including SSRIs, can effectively treat bipolar depression but they often trigger manic episodes as an unwanted side effect. 

• Standard dosage for bipolar depression in adults: 1.5–3 mg taken once daily

• Maximum dosage for bipolar depression mania in adults: 3 mg per day

Vraylar dosage for children

Clinical studies have not been conducted in patients less than 18 years of age therefore the FDA has not approved the pediatric use of Vraylar. 

Vraylar dosage restrictions

Because of side effects, Vrayler could worsen certain pre-existing physical conditions. These include heart problems, cardiovascular disease, cerebrovascular disease, seizure disorders, diabetes, and low white blood cell counts (leukopenia or neutropenia). Elderly patients with dementia-related psychosis are at an increased risk of death when taking Vraylar. In addition, some people may have a history of drug-induced problems that could re-occur if they take Vraylar. These include neuroleptic malignant syndrome (NMS), a serious side effect of antipsychotic drugs, and drug-induced low white blood cell counts. In all these cases, reducing the dose of Vraylar will not be required, but healthcare professionals should monitor adverse reactions carefully before they develop into serious problems. The only people who will never be prescribed Vraylar are those allergic to the drug.

Drugs like Vraylar are frequently broken down by the liver and the drug or its metabolites are eliminated by the kidneys.  There are no Vraylar dosage adjustments recommended for mild to moderate liver or kidney impairment, however, it should not be used in patients with severe liver or kidney impairment.

How to take Vraylar

Each dose of Vraylar is taken once per day by mouth. Currently, the only available dosage form is capsules.

• Take Vraylar as instructed by the prescribing healthcare provider. Never exceed the recommended dose. The dose may change several times, so be careful to understand the currently prescribed dose.

• This medicine should come with a medication guide. A pharmacist can provide a copy if it’s missing. Please read this guide carefully before taking the medication.

• Swallow the Vraylar capsule whole with a glass of water.

• Vraylar can be taken with or without food.

• Do not stop taking Vraylar until talking to a healthcare provider.

• Store this medicine at room temperature (68°F to 77°F) out of the reach of children.

Vraylar impairs the ability of the body to reduce core body temperature, raising the risk of hyperthermia. When taking Vraylar, avoid strenuous exercise, hot temperatures, and anticholinergic medications (such as overactive bladder drugs, urinary continence medications, and COPD medications).

Vraylar dosage FAQs

How long does it take Vraylar to work?

It may take a few weeks to notice improvements in symptoms. This is because it takes around four to eight weeks of daily dosing for cariprazine and its major active metabolites to reach a steady-state concentration in the bloodstream. In clinical trials comparing cariprazine to a placebo, symptoms improved in people with schizophrenia as early as one week after starting. For mania, symptoms significantly improved in three weeks.

How long does Vraylar stay in your system?

It takes the body about eight weeks to clear a dose of Vraylar from the body. The unusually long half-life is due to Vraylar’s complex pharmacokinetics, that is, the way the drug is handled by the body. The body first breaks down cariprazine, the active ingredient in Vraylar, into another drug. It then breaks down that second drug into a third drug. These two drugs, called major active metabolites, work the same way and are just as powerful as cariprazine. Taken together, the effective half-life, the time it takes for the amount of a drug's active substances in your body to reduce by half, of a dose of Vraylar and its two active metabolites is one week.

What happens if I miss a dose of Vraylar?

Take a missed dose as soon as it’s remembered. However, if it’s nearly time for the next dose, skip the missed dose and take the next scheduled dose at its regular time.

How long can you take Vraylar?

In general, healthcare providers prescribe Vraylar over the short term for bipolar mania but may prescribe it for a longer period to treat schizophrenia or bipolar depression. Although Vraylar can theoretically be taken over the long-term, using the drug for too long or at high doses does increase the risk for drug-induced movement problems called extrapyramidal symptoms, particularly in older people. Extrapyramidal reactions include involuntary facial movements (tardive dyskinesia), loss of muscle tone (dystonia), twitching, and uncontrollable impulses to move (akathisia). These problems may not be reversible if the drug is taken for too long a time.

How do I stop taking Vraylar?

When cariprazine is stopped, a healthcare provider will use a steadily decreasing dose. The sudden discontinuation of Vraylar can cause antipsychotic withdrawal symptoms such as nausea, vomiting, headache, sleeplessness, restlessness, anxiety, sweating, fast heartbeat, muscle pain, and numbness.

Vraylar has high tolerability, that is, it has a low potential to cause harm. Still, there are good reasons to stop taking Vraylar. Serious side effects such as suicidal thoughts, extrapyramidal reactions, high blood sugar (hyperglycemia), high blood levels of fats and cholesterol (dyslipidemia), or seizures may require the drug to be discontinued for safety reasons. However, some people may not be able to tolerate less serious side effects such as constipation, drowsiness, upset stomach (dyspepsia), metabolic changes, and weight gain. Drug interactions might also cause problems that require Vraylar to be at least temporarily discontinued.

Fortunately, there are alternatives. People with schizophrenia can turn to a wide range of antipsychotic drugs. People with bipolar can switch to another antipsychotic, a mood stabilizer like lithium or carbamazepine, an antidepressant, or a combination antidepressant and antipsychotic such as Symbyax (olanzapine and fluoxetine). Seroquel (quetiapine) and Latuda (lurasidone), both antipsychotics like Vraylar, are also approved to treat bipolar depression.   

What is the maximum dosage for Vraylar?

The maximum daily dose of Vraylar is 6 mg in people taking Vraylar for schizophrenia or bipolar mania or mixed episodes. It is 3 mg daily in people taking Vraylar for bipolar depression.

Can you overdose on Vraylar?

An overdose of Vraylar is not fatal but may require hospitalization for observation. Taking too much Vraylar may cause somnolence and orthostatic hypotension, that is, a rapid fall in blood pressure when standing. Call a poison helpline or get emergency medical treatment if an overdose is suspected.

Is it safe to take Vraylar during pregnancy?

The risk of birth defects and miscarriages for pregnant women taking Vraylar is unknown. However, healthcare providers are cautious about using Vraylar during the third trimester. When used too late in a pregnancy, there is a risk that newborns will experience antipsychotic withdrawal symptoms or involuntary muscle movements (extrapyramidal reactions) from exposure to the drug. 

There are no studies of Vraylar’s effects on a nursing baby. Breastfeeding mothers should consult with a healthcare provider about the possible risks to the infant when taking Vraylar.

Related resources for Vraylar dosages:

• Antipsychotic withdrawal symptoms: A systematic review and meta-analysis, Frontiers in Psychiatry

• Cariprazine compound information, U.S. National Library of Medicine

• Cariprazine as a treatment across the bipolar I spectrum from depression to mania: mechanism of action and review of clinical data, Therapeutic Advances in Psychopharmacology

• Review of cariprazine in management of psychiatric illness, The Mental Health Clinician

• Vraylar, Epocrates

• Vraylar prescribing information, U.S. National Library of Medicine

• Vraylar HCP, AbbVie