Vraylar can also increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults. It is not FDA-approved for use in children. Before starting treatment, talk to your healthcare provider about the potential safety risks associated with Vraylar.
Vraylar is in a class of medications called second-generation antipsychotics. It works by increasing the amount of dopamine and serotonin in the brain through activity at both receptors.
Vraylar is available via prescription in 1.5-milligram (mg), 3-milligram, 4.5-milligram, and 6-milligram capsules.
What Is Vraylar Used For?
Vraylar is an antipsychotic medicine used in adults to treat:
Brand Name: Vraylar
Drug Availability: Prescription
Administration Route: Oral
Therapeutic Classification: Antipsychotic
Available Generically: No
Controlled Substance: N/A
Active Ingredient: Cariprazine
Dosage Form: Capsule
Schizophrenia Manic or mixed episodes associated with bipolar I disorder Depressive episodes associated with bipolar I disorder Major depressive disorder in combination with antidepressants
How to Take Vraylar
Vraylar can be taken with or without food. Follow all the directions on your medication’s prescription label. Use as directed by your healthcare provider. Do not take more than prescribed.
Before starting treatment, talk to your healthcare provider or pharmacist about potential safety precautions for taking Vraylar.
Storage
Store Vraylar tablets in a tightly closed container at a controlled room temperature (between 68 F and 77 F). Protect from light to prevent color fading on the capsules. Keep out of the reach of children and pets to prevent accidental consumption. When traveling, transport cariprazine in your carry-on or your checked baggage with its original label.
Off-Label Uses
Healthcare providers may prescribe cariprazine for off-label uses, meaning for conditions not specifically indicated by the FDA.
Cariprazine may be used off-label for schizoaffective disorder (a combination of schizophrenia and mood disorder symptoms).
While this is not an FDA-approved use, and there is no evidence that cariprazine effectively treats this condition, some healthcare providers may still prescribe it. Misusing this medication without the advice of a healthcare provider can result in severe or life-threatening side effects.
What Are the Side Effects of Vraylar?
This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.
Common Side Effects
Common side effects reported with Vraylar include:
Akathisia (restlessness) Back pain Blurred vision Constipation Dizziness Dyspepsia (indigestion) Dystonia (involuntary muscle contractions) Extrapyramidal symptoms (uncontrolled movements) Fatigue Headache Increased blood pressure Insomnia Nausea or vomiting Somnolence (drowsiness) Tachycardia (rapid heart rate) Increased appetite Xerostomia (dry mouth)
Severe Side Effects
Notify your healthcare provider immediately if you have serious side effects. Call 911 immediately if your symptoms feel life-threatening or you think you or someone else is having a medical emergency.
Vraylar has a boxed warning (the FDA’s strictest safety-related warning that can be assigned to medications), which states:
Vraylar should not be used in people of advanced age with dementia-related psychosis due to the increased risk of death. Vraylar can also increase the risk of suicidal thoughts and behaviors in children and young adults.
Other potentially severe side effects can include the following:
Agranulocytosis (low granulocytes): Agranulocytosis does not cause symptoms, but a drop in your white blood cell count often leads to infections. Diabetes: Atypical antipsychotic drugs can cause metabolic changes, such as diabetes. Common symptoms include excessive urination and thirst, increased hunger, weight loss, fatigue, and numbness and tingling in the hands and feet. Dysphagia (difficulty swallowing): Symptoms can include pain when swallowing, feeling like food is stuck in your throat or chest, hoarseness, and regurgitation. Hyperglycemia (high blood sugar): High blood sugar can cause excessive thirst, increased urination, increased hunger, blurry vision, and fatigue. Hyperthermia (elevated body temperature): Vraylar can affect the body’s ability to regulate and reduce its core temperature, especially with strenuous exercise, exposure to extreme heat, dehydration, and in people taking anticholinergic medications. Leukopenia (low white blood cells): Symptoms can include fever, chills, sweats, sore throat, congestion, weight loss, enlarged lymph nodes, and enlarged liver or spleen. Neuroleptic malignant syndrome (NMS): NMS is a rare and life-threatening condition. Symptoms can include muscular rigidity, extremely elevated body temperature, tremors, muscle cramps, and agitation. Neutropenia (low neutrophils): Common symptoms include fatigue, high fevers, sweats or chills, muscle aches, and recurrent episodes of sore throats, mouth sores, non-healing wounds, diarrhea, or painful urination. Orthostatic hypotension (dizziness upon standing): You may feel dizzy when standing up after sitting or lying down for a long time. Seizures: Vraylar should be used with caution in people with a history of seizures. Stevens-Johnson syndrome (a potentially life-threatening skin condition): The condition usually starts with flu-like symptoms and progresses to a burning sensation on the lips, inside of the cheeks, and eyes, a flat red rash or blisters, swelling of the face or tongue, red or bloodshot eyes, sensitivity to light, and painful ulcers or erosions of the mouth, nose, eyes, and genital mucosa. Stroke or transient ischemic attack (mini-stroke): Vraylar should be used with caution in people who have or have had heart disease or stroke. Syncope (fainting)
Long Term Side Effects
Cariprazine can have long-lasting effects on your body up to several weeks after you stop using it.
Tardive dyskinesia (uncontrolled repetitive movements) can occur during treatment and continue for some time after it is discontinued. Contact your healthcare provider if you experience signs of tardive dyskinesia during or after stopping cariprazine.
Dosage: How Much Vraylar Should I Take?
Modifications
Certain factors may affect how you take your medication. The following should be kept in mind when taking Vraylar.
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (capsules): For bipolar disorder and manic episodes related with schizophrenia: Adults—At first, 1. 5 milligrams (mg) once a day. Your doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mg per day. Children—Use and dose must be determined by your doctor. For depressive episodes related with schizophrenia: Adults—At first, 1. 5 milligrams (mg) once a day. Your doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 3 mg per day. Children—Use and dose must be determined by your doctor.
Pregnancy
Based on animal data, Vraylar may cross the placenta and cause fetal harm. While animal data does not always necessarily translate to human experience, treatment with Vraylar is still used cautiously in pregnant people due to the potential risks.
Newborn infants exposed to the drug during the third trimester are at risk for uncontrolled movements and/or withdrawal symptoms after delivery.
If you have to take this medication while pregnant, your healthcare provider may enroll you in a National Pregnancy Registry for atypical antipsychotics.
Lactation
Cariprazine is present in rat milk. There is no human data available to assess the risk of infant harm or effects on milk production. People taking cariprazine are advised to avoid breastfeeding. Notify your healthcare provider if you are breastfeeding and want to continue or start Vraylar.
Kidney or Liver Problems
No dosage change is necessary for mild to moderate kidney or liver impairment. However, Vraylar is not recommended in people with severe kidney or liver impairment.
Missed Dose
If you miss a dose of this medication, take it as soon as you remember. You can skip the missed dose if it is almost time for your next dose. Resume medication at your next scheduled time. Do not take extra to make up for the missed dose. Call your healthcare provider or pharmacist if you need help with what to do.
Overdose: What Happens If I Take Too Much Vraylar?
An overdose can happen if you take too much of your medication. Overdose symptoms associated with Vraylar include orthostasis (orthostatic hypotension) and sedation.
There is no specific treatment for Vraylar overdose. Contact your healthcare provider or the Poison Control Center for guidance on what to do if you take too much of the medication.
Precautions
What Are the Reasons I Shouldn’t Take Vraylar?
Avoid taking Vraylar if you are allergic to it or any of its components. Allergy reactions include rash, itch, hives, and angioedema.
If someone collapses or isn’t breathing after taking Vraylar, call 911 immediately.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.
Check with your doctor right away if you have convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
For diabetic patients: This medicine may cause high blood sugar levels (hyperglycemia). Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.
Cariprazine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
This medicine may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine might reduce how much you sweat and make you feel too hot. You might feel dizzy, weak, tired, or confused, or begin to vomit or have an upset stomach. Do not get too hot while exercising and avoid places with high temperatures. Call your doctor if you become overheated and cannot cool down.
Make sure your doctor knows if you are pregnant. Do not use this medicine during the last 3 months of a pregnancy unless your doctor tells you to.
Some side effects may not happen right away and can start a few weeks after you start using this medicine or if your dose increases. Do not change your dose or stop using your medicine without first checking with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
What Other Medications Interact With Vraylar?
Before starting treatment, tell your healthcare provider about any other medicines you take or plan to take, including over-the-counter (OTC) nonprescription products, vitamins, herbs, supplements, and plant-based medicines.
Watch out for these medications when taking Vraylar, as they can affect how it works in the body.
Strong CYP3A4 Inhibitors
Avoid using Vraylar with a strong CYP3A4 inhibitor, such as Sporanox (itraconazole) and ketoconazole. CYP3A4 is an enzyme that forms and eliminates the metabolites of cariprazine. This combination increases Vraylar levels in the body. If they must be used together, your healthcare provider may reduce your dosage of Vraylar.
CYP3A4 Inducers
Avoid using Vraylar with CYP3A4 inducers, such as rifampin and Tegretol (carbamazepine). CYP3A4-inducing medications encourage the CYP3A4 enzyme to break down Vraylar more quickly in the body, which can reduce how well it works.
This is not a comprehensive list of medications that may affect how Vraylar works. Others may increase the risk of severe side effects from cariprazine. Talk with your pharmacist or healthcare provider for more detailed information about interactions with Vraylar.
What Medications Are Similar?
Medications similar to Vraylar include:
Abilify (aripiprazole) Geodon (ziprasidone) Latuda (lurasidone)
Aripiprazole
Aripiprazole is a second-generation antipsychotic like Vraylar, also used for treating schizophrenia, bipolar disorder, and major depressive disorder. Aripiprazole is also used in children as young as 6 to treat schizophrenia, bipolar disorder, autistic disorder-associated irritability, and Tourette syndrome. It works similarly to cariprazine, modulating dopamine and serotonin in the body.
Unlike Vraylar, aripiprazole can be used in people with severe kidney or liver problems. It is available as a tablet, injection, and liquid.
Ziprasidone
Ziprasidone is a second-generation antipsychotic like Vraylar. It is available as a capsule and intramuscular injection. Similarly to Vraylar, it treats schizophrenia and bipolar disorder. In addition, the injection formulation treats agitation in people with schizophrenia.
Ziprasidone works by blocking dopamine and serotonin receptors in the body. It is more limited than Vraylar, as the oral capsules must be taken with food. Unlike Vraylar, ziprasidone can be used in people with severe kidney or liver problems. However, it must be avoided in those with heart disease as it can worsen their condition.
Lurasidone
Lurasidone is a second-generation antipsychotic like Vraylar. It is available as a tablet. Similarly to Vraylar, it treats schizophrenia and bipolar disorder.
Latuda is also used in children as young as 10 to treat schizophrenia and bipolar disorder. It works by blocking dopamine and serotonin receptors in the body. It is more limited than Vraylar as it has to be taken with food (at least 350 calories).
How Can I Stay Healthy While Taking Vraylar?
Managing schizophrenia and bipolar disorder can be challenging for individuals living with these conditions and caregivers alike.
Death in older adults with dementia-related psychosis. Suicidal thoughts or actions in children and young adults. A severe movement disorder that may not be reversible.
It is not approved for use in children.
If you take too much, seek emergency help or call the Poison Control Center immediately.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how the medication affects you. Do not become too hot or dehydrated during treatment. Do not stay out in the sun. Avoid strenuous exercise. Do not wear too much clothing or heavy clothing. Avoid alcohol, as this medication may make you drowsy.
When undergoing treatment, it is essential to:
Take your medication as prescribed. Pay close attention to any changes in mood, behaviors, thoughts, or feelings. Report any new or sudden changes to your healthcare provider. Be patient, as symptoms may not improve for several weeks. Consider using technology, such as your smartphone or medication adherence apps, to set up reminders if you have trouble remembering your doses.
As with any medication, talk to your healthcare provider or pharmacist if you have any questions or concerns.
