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Vraylar 6mg Capsule
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Indications & Clinical Uses
- Vraylar 6 mg capsules contain cariprazine, an atypical (second-generation) antipsychotic taken by mouth once daily.
- In the US it is approved to treat schizophrenia in adults and in children aged 13 and over, manic or mixed episodes of bipolar I disorder in adults and children aged 10 and over, depressive episodes of bipolar I disorder in adults, and as an add-on to an antidepressant for major depressive disorder in adults.
- In the EU it is marketed as Reagila for schizophrenia in adults only.
- Vraylar comes in six capsule strengths (0.5, 0.75, 1.5, 3, 4.5 and 6 mg); 6 mg is the highest strength and the dose depends on the condition being treated, so take only the strength your prescriber chooses.
- It is a prescription medicine.
Side Effects
- The most common reactions depend on the condition.
- Restlessness (akathisia) and movement problems such as tremor or stiffness (extrapyramidal symptoms) are the most frequent: akathisia affected roughly 6% to 23% and movement symptoms 4% to 29% of patients across studies.
- Insomnia, tiredness, nausea, vomiting and sleepiness were also common.
- Serious reactions include neuroleptic malignant syndrome (high fever, stiff muscles, confusion), tardive dyskinesia (uncontrolled movements), stroke-related events in older people, high blood sugar and cholesterol, weight gain, low white blood cell counts, low blood pressure on standing, fainting, falls, seizures, trouble swallowing and problems controlling body temperature.
- Boxed warnings: increased risk of death in elderly patients with dementia-related psychosis, and increased suicidal thoughts and behaviors in children and young adults.
- Some side effects can appear late because the medicine stays in the body for weeks.
Precautions & Warnings
- Boxed warnings: Vraylar is not approved for dementia-related psychosis in older adults because of an increased risk of death, and antidepressant-type medicines increase suicidal thoughts and behaviors in children, teenagers and young adults, so mood changes need close watching.
- Do not use if you have had an allergic reaction to cariprazine.
- Blood sugar, blood fats and weight should be monitored, and blood counts checked if you are at risk of low white cells.
- The medicine has a long half-life, so the effect of a dose change is not fully seen for several weeks; your prescriber should monitor you for several weeks after starting and after each dose change.
- Pregnancy: animal data suggest possible fetal harm, babies exposed in the third trimester may have movement problems or withdrawal symptoms, and a pregnancy registry exists (National Pregnancy Registry for Atypical Antipsychotics, 1-866-961-2388).
- Breastfeeding: not studied in humans.
- Avoid driving or hazardous machinery until you know how it affects you.
Avoid Interactions
- Increase exposure: strong or moderate CYP3A4 inhibitors raise cariprazine levels significantly, and the label requires the dose to be reduced when they are used; your prescriber will adjust the dose.
- Reduce effect: CYP3A4 inducers (medicines that speed up liver breakdown) can lower cariprazine levels, and using them together is not recommended.
- Vraylar stays in the body for weeks, so changes in interacting medicines can have delayed effects.
- The label sections reviewed did not address alcohol.
- Tell your healthcare provider about all prescription medicines, non-prescription products, herbal products and supplements before starting or stopping anything.
References
- VRAYLAR (cariprazine) - US Prescribing Information, DailyMed
- VRAYLAR (cariprazine) - FDA label 2024, accessdata.fda.gov
- VRAYLAR (cariprazine) - Prescribing Information (AbbVie)
- VRAYLAR (cariprazine) - FDA label 2017 (how supplied and storage), accessdata.fda.gov
- Reagila (cariprazine) EPAR summary for the public - European Medicines Agency
Frequently Asked Questions
Vraylar (cariprazine) is an antipsychotic taken by mouth for schizophrenia, bipolar I mania or mixed episodes, bipolar depression, and as an add-on to an antidepressant for major depression. Age limits differ by condition: schizophrenia from 13, bipolar mania from 10, and the other uses in adults only.
Take Vraylar (cariprazine) by mouth once a day, with or without food, at the strength your prescriber chooses. Vraylar comes in 0.5 to 6 mg capsules and the dose depends on the condition. Do not change the dose yourself, because the effect of a change takes weeks to show.
Vraylar commonly causes restlessness (akathisia), movement problems, insomnia, tiredness, nausea, vomiting and sleepiness. Serious effects include high fever with stiff muscles, uncontrolled movements, high blood sugar, low white blood cells, fainting and seizures. Report these to your healthcare provider promptly.
Do not combine Vraylar (cariprazine) with CYP3A4 inducers, which are not recommended, and tell your prescriber about CYP3A4 inhibitors, which need a lower Vraylar dose. Avoid driving or hazardous machinery until you know how Vraylar affects you. Report any new mood changes or suicidal thoughts.
Vraylar (cariprazine) has a long half-life, so a dose change is not fully reflected in the blood for several weeks. Your prescriber should monitor you for side effects and response for several weeks after starting Vraylar and after every dose change.
Vraylar has two boxed warnings. Older adults with dementia-related psychosis treated with antipsychotics like cariprazine have a higher risk of death. Antidepressant-type medicines also raise the risk of suicidal thoughts and behaviors in children and young adults, so report any mood changes at once.
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