• Vraylar is a brand (trade) name for cariprazine which may be used to treat schizophrenia, bipolar I disorder, or major depressive disorder in addition to antidepressants.
• The exact way Vraylar (cariprazine) works is unknown; however, experts suggest it could be mediated through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and serotonin Type 2 (5HT2A) receptor antagonism. Cariprazine forms two major metabolites, both of which are as active as cariprazine.
• Vraylar belongs to the class of medicines known as atypical antipsychotics. Atypical means an antipsychotic is less likely than other, typically older, antipsychotics to cause extrapyramidal symptoms and tardive dyskinesia.

• May be used for the treatment of schizophrenia in adults.
• Also approved for the acute treatment of manic, mixed, or depressive episodes associated with bipolar I disorder in adults.
• Can also be used alongside antidepressants in adults with major depressive disorder (MDD).
• May be taken with or without food.
• Vraylar is an atypical antipsychotic which means it is less likely than older antipsychotics to cause extrapyramidal symptoms and tardive dyskinesia.
• The use of Vraylar has been associated with a decrease in substance abuse in patients with bipolar I disorder.
• Taken orally (by mouth), once a day.
• Available in 1.5mg, 3mg, 4.5mg, and 6mg capsule strengths.
• Less likely than some other antipsychotics ( such as Clozaril or Zyprexa) to cause elevations in blood sugar levels.
• Less likely than other atypical antipsychotics (such as Zyprexa or Seroquel) to cause elevations in blood cholesterol and lipids.
• Usually well-tolerated and has a good effect.
• Less sedating than other atypical antipsychotics, such as Clozaril, Zyprexa, or Seroquel. In clinical trials, sedation was reported in 7% of patients treated with Vraylar compared to 6% of placebo-treated patients.
• Has a long half-life which means blood levels take a long time to fall if a person misses a dose or takes their dose late. Blood levels also remain more stable with once-daily dosing.
• Has not been associated with as much weight gain as some other antipsychotics.
• Not a controlled drug.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Akathisia (a feeling of inner restlessness), difficulty moving or slow movements, dyspepsia (heartburn), nausea or vomiting, and somnolence (drowsiness) are the most common side effects reported. Body temperature dysregulation, dysphagia (difficulty swallowing), insomnia, and extrapyramidal symptoms have also been reported.
• Drowsiness, that may affect a person's ability to drive or operate machinery or perform other hazardous tasks. Advise people taking Vraylar to exercise caution and not to drive if Vraylar makes them sleepy. They should also avoid drinking alcohol while taking Vraylar.
• Should not be used for the treatment of dementia-related psychosis in elderly people as associated with a higher risk of death.
• Many antidepressants and antipsychotics such as Vraylar have been associated with an increased risk of suicidal thoughts and behaviors in children and young adults in trials. Closely monitor all people for worsening depression, agitation, or mood changes.
• May cause a drop in blood pressure on standing, particularly at the start of treatment or following any dosage increases. May not be suitable for people with known cardiovascular disease (history of a heart attack, angina, heart failure, or arrhythmia), stroke, seizure disorders, and people at risk of dehydration.
• Blood levels may need monitoring as Vraylar can cause the numbers of white blood cells to decrease and leukopenia, neutropenia, and agranulocytosis have been reported. Risk is higher in those with a pre-existing low WBC or a history of drug-induced leukopenia or neutropenia.
• Vraylar may also increase a person's risk for a fall, bone fracture, or other injuries, especially if they are drowsy or sedated. The risk is greater in older patients.
• Atypical antipsychotics like Vraylar may prevent proper body temperature regulation and increase the risk of dehydration. Advise patients to avoid exercising too much, stay inside and out of the sun and in a cool place when possible, wear lightweight clothing, and drink plenty of fluids. The risk is increased in people taking anticholinergics.
• Tardive dyskinesia is an uncommon side effect of Vraylar. In studies, tardive dyskinesia occurred in less than 1% of bipolar depression patients taking the 3 mg per day dose. Symptoms include uncontrolled movements of the face, tongue, or other body parts, such as tongue thrusting, repetitive chewing, jaw swinging, or facial grimacing.
• Rarely, may cause Neuroleptic Malignant Syndrome; symptoms include high body temperature, muscle rigidity, and mental disturbances; discontinue immediately and seek urgent medical advice.
• May interact with several drugs, including benzodiazepines, itraconazole, diltiazem, and verapamil. See prescribing information for a full list of interactions.
• Not approved for use by anyone younger than 18 years old. Hypersensitivity reactions have been reported. Vraylar should not be taken by people who are allergic to any ingredients in the product.
• Vraylar may potentially harm an unborn baby. Advise against pregnancy. If a woman inadvertently becomes pregnant then enroll her in the National pregnancy registry for Atypical Antipsychotics at 1-866-961-2388. It is unknown what effects Vraylar has on a newborn during breastfeeding.
• No generic form of Vraylar is currently available and it may be more expensive than other antipsychotics.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• May be taken either in the morning or at night, depending on your preference. Some people find that changing the time you take Vraylar helps with certain side effects. For example, people who experience restlessness or restless legs as a side effect may find taking it in the morning helpful. Up to 10% of people taking Vraylar report sleepiness or drowsiness as a side effect; the risk of this side effect increases with higher dosages, and these people may prefer taking it at night.
• May be taken with or without food.
• Avoid eating grapefruit or drinking grapefruit juice during treatment with Vraylar.
• If you do experience sleepiness with Vraylar, be careful driving, operating machinery, or performing other tasks that require high levels of concentration. Vraylar may also increase your risk of falling. Talk to your doctor if your side effects are intolerable and interfere with your day-to-day life.
• Vraylar may increase your risk of becoming too hot or dehydrated during treatment. Avoid exercising too much, and stay inside and out of the sun and in a cool place when possible. Wear lightweight clothing and drink plenty of fluids.
• Call a health care provider right away if you or your family member taking Vraylar experiences worrying symptoms such as thoughts about suicide or dying, new or worsening depression, feeling very agitated or restless, trouble sleeping (insomnia), acting aggressive, being angry, or violent, an extreme increase in activity and talking (mania), or any other unusual changes in behavior or mood.
• Call for emergency medical help if you think you are having an allergic reaction. Signs can include hives, difficulty breathing, and swelling of your face, lips, tongue, or throat.
• Vraylar may make you feel dizzy when going from a sitting or lying down position to standing. This may increase your risk of falls. Stand up slowly and remove any fall hazards from your home (such as loose rugs).
• Talk with your doctor if you develop any worrying side effects such as uncontrollable facial grimacing, restlessness, severe dizziness, or severe abdominal discomfort.
• Atypical antipsychotics like Vraylar may increase your risk of becoming too hot or dehydrated during treatment. Avoid exercising too much, and stay inside and out of the sun and in a cool place when possible. Wear lightweight clothing and drink plenty of fluids.
• Seek urgent medical advice if you develop unusual body movements, confusion, high fever, lightheadedness, fainting, seizures, problems controlling your body temperature, or difficulty swallowing.
• Tell your doctor if you are intending to become pregnant and you are taking Vraylar as your doctor may wish to change you to a different medication. If you do inadvertently become pregnant then enroll in the National pregnancy registry for Atypical Antipsychotics at 1-866-961-2388. It is unknown what effects Vraylar has on a newborn during breastfeeding.
• Alcohol may enhance or worsen the side effects of Vraylar so it is best to avoid drinking it if you have been prescribed Vraylar.
• Tell other health professionals that you are being administered Vraylar and do not take any other medications or supplements without talking to a doctor or pharmacist first to ensure they are compatible with Vraylar.

• Vraylar its active metabolites have a long half-life: 2 to 4 days for cariprazine, 1 to 2 days for one active metabolite called DCAR, and approximately 1 to 3 weeks for another active metabolite DDCAR. This means that once Vraylar has been taken for a few weeks, levels of Vraylar in the blood remain consistent and do not fluctuate much when taken once daily. Some side effects may not occur until a few weeks after starting Vraylar or after a dose change.
• It normally takes at least 5 half-lives to get most of a drug out of your system, so it could take at least 15 weeks (over 100 days) for Vraylar to be eliminated, although the half-life and elimination of a drug can vary from person to person based on age, weight, genetics, other medicines they take or even or medical conditions.
• The effectiveness of Vraylar was established in three, 6-week studies that showed Vraylar was superior to a placebo and, in two studies, equivalent to the active control. The efficacy was established at doses ranging from 1.5mg to 9mg; however, significantly more adverse effects happened at dosages above 6mg, therefore the maximum recommended dosage is 6mg/day.
• The studies showed the change from baseline PANSS total score (placebo-subtracted difference) ranged from -6.0 to -7.6 with the 1.5mg/day dosage to -8.8 to -10.4 with the higher dosage (4.5-6 mg/day dosage.
• Studies of patients with manic or mixed episodes associated with bipolar I disorder used the Young Mania Rating Scale (YMRS) with an average placebo-subtracted difference score of -4.3 to -6.1 for the dose range of 3-12 mg/day.
• For depressive episodes associated with bipolar I disorder, three studies showed Vraylar was significantly superior to placebo at the end of week 6 using the MADRAS total score.

Medicines that interact with Vraylar may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Vraylar. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Vraylar include:

• anti-anxiety medications such as diazepam and oxazepam
• anticonvulsants, such as phenytoin
• antidepressants, such as amitriptyline, imipramine, nortriptyline
• antifungals, such as itraconazole or ketoconazole
• antihistamines that cause sedation, such as diphenhydramine
• baclofen
• bosentan
• bupropion
• cannabis
• diuretics such as bendroflumethiazide
• duloxetine
• heart medications such as atenolol, timolol, or nifedipine
• HIV medications such as indinavir and ritonavir
• monoamine oxidase inhibitors, such as isocarboxazid, or phenelzine
• opioid analgesics such as codeine, oxycodone, and morphine
• modafinil
• muscle relaxants such as cyclobenzaprine
• rifampin
• serotonin modulators, such as nefazodone and trazodone
• sleeping pills, such as zolpidem
• some chemotherapy treatments
• some heart medications, such as diltiazem, or verapamil
• other medications used to treat mental illness, such as clozapine and thioridazine
• any medication that inhibits (itraconazole, ketoconazole) or induces (rifampin, carbamazepine) CYP3A4.

Alcohol may worsen the side effects of Vraylar such as drowsiness, dizziness, and liver toxicity.

Avoid eating grapefruit or drinking grapefruit juice during treatment with Vraylar because it may increase blood levels and increase the risk of side effects such as Parkinsons-like symptoms, seizures, high blood sugar levels, and heat intolerance.

Vraylar is unlikely to interact with caffeine. However, if you find that you are having trouble sleeping after starting Vraylar, you may also want to cut back on any caffeine consumption, especially later in the day. This includes coffee, tea, cola, chocolate, and energy drinks.

Note that this list is not all-inclusive and includes only common medications that may interact with Vraylar. You should refer to the prescribing information for Vraylar for a complete list of interactions.