Brand name: Vraylar ®
- Tablets: 1.5mg, 3mg, 4.5mg, 6mg capsules
Medication class: Second generation antipsychotic (SGA), atypical antipsychotic
All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication.
What is cariprazine and what does it treat?
Cariprazine is a medication that works in the brain to treat schizophrenia. It is also known as a second-generation antipsychotic (SGA) or atypical antipsychotic. Cariprazine rebalances dopamine and serotonin to improve thinking, mood, and behavior.
Symptoms of schizophrenia include:
- Hallucinations - imagined voices or images that seem real
- Delusions - beliefs that are not true (e.g., other people are reading your thoughts)
- Disorganized thinking or trouble organizing your thoughts and making sense
- Little desire to be around other people
- Trouble speaking clearly
- Lack of motivation
Cariprazine may help some or all of these symptoms.
Cariprazine is also FDA approved for the following indications:
- Acute treatment of manic or mixed episodes of bipolar I disorder
What is the most important information I should know about cariprazine?
Schizophrenia requires long-term treatment. Do not stop taking cariprazine even when you feel better.
Only your healthcare provider can determine the length of cariprazine treatment that is right for you.
Missing doses of cariprazine may increase your risk for a relapse in your symptoms.
Do not stop taking cariprazine or change your dose without talking to with your healthcare provider first.
For cariprazine to work properly, it should be taken every day as ordered by your healthcare provider.
Are there specific concerns about cariprazine and pregnancy?
If you are planning on becoming pregnant, notify your healthcare provider to best manage your medications. People living with schizophrenia who wish to become pregnant face important decisions. This is a complex decision since untreated schizophrenia has risks to the fetus, as well as the mother. It is important to discuss the risks and benefits of treatment with your doctor and caregivers.
Caution is advised with breast-feeding. It is unknown whether cariprazine is present in breast milk.
What should I discuss with my healthcare provider before taking cariprazine?
- Symptoms of your condition that bother you the most
- If you have thoughts of suicide or harming yourself
- Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects
- If you ever had muscle stiffness, shaking, tardive dyskinesia, neuroleptic malignant syndrome, or weight gain caused by a medication
- If you experience side effects from your medications, discuss them with your provider. Some side effects may pass with time, but others may require changes in the medication.
- Any psychiatric or medical problems you have, such as heart rhythm problems, long QT syndrome, heart attacks, diabetes, high cholesterol or seizures
- If you have a family history of diabetes or heart disease
- All other medications you are currently taking (including over the counter products, herbal and nutritional supplements) and any medication allergies you have
- Other non-medication treatment you are receiving, such as talk therapy or substance abuse treatment
- If you are pregnant, plan to become pregnant or are breast-feeding
- If you smoke, drink alcohol or use illegal drugs
How should I take cariprazine?
Cariprazine is usually taken once daily with or without food.
Typically patients begin at a low dose of medicine and the dose is increased slowly over several weeks. Only your healthcare provider can determine the correct dose for you.
The dose usually ranges from 1.5mg to 6mg. Only your healthcare provider can determine the correct dose for you.
Use a calendar, pillbox, alarm clock, or cell phone alert to help you remember to take your medication. You may also ask a family member a friend to remind you or check in with you to be sure you are taking your medication.
What happens if I miss a dose of cariprazine?
If you miss a dose of cariprazine, take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.
What should I avoid while taking cariprazine?
Avoid drinking alcohol or using illegal drugs while you are taking cariprazine. They may decrease the benefits, including worsening your confusion, and increase adverse effects, including sedation, of the medication.
What happens if I overdose with cariprazine?
If an overdose occurs call your doctor or 911. You may need urgent medical care. You may also contact the poison control center at 1-800-222-1222.
A specific treatment to reverse the effects of cariprazine does not exist.
What are possible side effects of cariprazine?
Common Side Effects
Headache, sleepiness, insomnia, nausea, constipation.
Rare Side Effects
Low sodium levels, muscle pain, excessive sweating, hepatitis
Serious Side Effects
Some people may develop muscle related side effects while taking cariprazine. The technical terms for these are “extrapyramidal effects” (EPS) and “tardive dyskinesia” (TD). Symptoms of EPS include restlessness, tremor, and stiffness. TD symptoms include slow or jerky movements that one cannot control, often starting in the mouth with tongue rolling or chewing movements.
Second generation antipsychotics (SGAs) increase the risk of weight gain, high blood sugar, and high cholesterol. This is also known as metabolic syndrome. Your healthcare provider may ask you for a blood sample to check your cholesterol, blood sugar, and hemoglobin A1c (a measure of blood sugar over time) while you take this medication.
- Information on healthy eating and adding exercise to decrease your chances of developing metabolic syndrome may be found at the following sites:
SGAs have been linked with higher risk of death, strokes, and transient ischemic attacks (TIAs) in elderly people with behavior problems due to dementia.
All antipsychotics have been associated with the risk of sudden cardiac death due to an arrhythmia (irregular heart beat). To minimize this risk, antipsychotic medications should be used in the smallest effective dose when the benefits outweigh the risks. Your doctor may order an EKG to monitor for irregular heart beat.
Neuroleptic malignant syndrome is a rare, life threatening adverse effect of antipsychotics which occurs in <1% of patients. Symptoms include confusion, fever, extreme muscle stiffness, and sweating. If any of these symptoms occur, contact your healthcare provider immediately.
Are there any risks for taking cariprazine for long periods of time?
Tardive dyskinesia (TD) is a side effect that develops with prolonged use of antipsychotics.
Medications such as cariprazine have been shown to have a lower risk of TD compared to older antipsychotics, such as Haldol (haloperidol). If you develop symptoms of TD, such as grimacing, sucking, and smacking of lips, or other movements that you cannot control, contact your healthcare provider immediately. All patients taking either first or second-generation antipsychotics should have an Abnormal Involuntary Movement Scale (AIMS) completed regularly by their healthcare provider to monitor for TD.
Second generation antipsychotics (SGAs) increase the risk of diabetes, weight gain, high cholesterol, and high triglycerides. (See “Serious Side Effects” section for monitoring recommendations.)
What other medications may interact with cariprazine?
The following medications may increase the levels and effects of cariprazine: itraconazole, ketoconazole
The following medications may decrease the levels and effects of cariprazine: rifampin, carbamazepine
How long does it take for cariprazine to work?
It is very important to tell your doctor how you feel things are going during the first few weeks after you start taking cariprazine. It will probably take several weeks to see big enough changes in your symptoms to decide if cariprazine is the right medication for you.
Antipsychotic treatment is generally needed lifelong for persons with schizophrenia. Your doctor can best discuss the duration of treatment you need based on your symptoms and illness.
- Hallucinations, disorganized thinking, and delusions may improve in the first 1-2 weeks
- Sometimes these symptoms do not completely go away
- Motivation and desire to be around other people can take at least 1-2 weeks to improve
- Symptoms continue to get better the longer you take cariprazine.
- It may take 2-3 months before you get the full benefit of cariprazine.
College of Psychiatric and Neurologic Pharmacists
Summary of FDA Black Box Warnings
Increased Mortality in Elderly Patients with Dementia Related Psychosis
- Both first generation (typical) and second generation (atypical) antipsychotics are associated with an increased risk of mortality in elderly patients when used for dementia related psychosis.
- Although there were multiple causes of death in studies, most deaths appeared to be due to cardiovascular causes (e.g. sudden cardiac death) or infection (e.g. pneumonia).
- Antipsychotics are not indicated for the treatment of dementia-related psychosis.