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Fact Table
| Fact Table | |
|---|---|
| Formula | C21H32Cl2N4O·HCl (cariprazine hydrochloride); C21H32Cl2N4O (cariprazine base) |
| License | FDA approved (NDA 204370; initial U.S. approval 2015); EMA authorized as Reagila in 2017; Health Canada authorized in 2022 |
| Bioavailability | Absolute bioavailability unknown; peak plasma cariprazine concentration occurs in ~3–6 hours; high-fat meal does not significantly affect Cmax or AUC |
| Legal status | Prescription only (Rx-only); not a controlled substance |
| Chemical Name | trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride |
| Elimination half-life | Cariprazine 2–4 days; desmethylcariprazine ~1–2 days; didesmethylcariprazine ~1–3 weeks |
| Dosage (Strength) | 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, and 6 mg oral capsules; taken once daily with or without food |
| Pregnancy | May cause fetal harm; no available human data to inform drug-associated risk; neonates exposed to antipsychotics in the third trimester are at risk for extrapyramidal and/or withdrawal symptoms |
| Brands | Vraylar; Reagila |
| Protein binding | 91–97% plasma protein bound, including active metabolites |
| PubChem CID | 11154555 |
| MedlinePlus | a615050 |
| ChEBI | 90933 |
| ATC code | N05AX15 |
| DrugBank | DB06016 |
| KEGG | D09876 (cariprazine hydrochloride); D09997 (cariprazine) |
| Routes of administration | By mouth (oral capsules) |
Vraylar is a prescription bipolar disorder treatment medication also used to treat schizophrenia and bipolar depression. Cariprazine is part of the antipsychotic class of drugs, and it is well known for the effectiveness it has for stabilizing mental health and allowing patients to be less debilitated by their mental illness.
Vraylar works by restoring and balancing neurotransmitter chemicals in the brain and it is essential that patients take their medication consistently as indicated in their prescription in order to obtain best treatment results. Working with a qualified mental health professional along with medication use will also be beneficial in most cases.
Directions
Standard dosage is one Vraylar 1.5mg or 3mg capsule taken once daily. Stronger 4.5mg or 6mg Vraylar dosages may be recommended by a doctor and will be indicated in your prescription. Medication should be taken around the same time everyday and may be taken with or without food.
Always take your medication exactly as indicated in your prescription.
Ingredients
The active ingredient in Vraylar is Cariprazine.
Cautions
Let your doctor know if you have any history of heart problems, stroke, low or high blood pressure, diabetes or high blood sugar, high cholesterol, seizures, kidney or liver problems, or low white blood cell count before starting on Vraylar.
Only use Vraylar if you are pregnant or plan to become pregnant when approved to do so by a doctor.
Vraylar use may make you drowsy. Drive or use machinery with caution.
Avoid become overly heated or dehydrated when taking Vraylar.
Interactions
Negative drug interactions are possible between Vraylar and other Rx medications, including metoclopramide, bupropion (Wellbutrin), duloxetine, and buspirone. It is best to inform your doctor of all medications you are currently taking before getting a prescription and proceeding to buy Vraylar online.Side Effects
Vraylar side effects may occur, and some users may experience excessive hunger or thirst, stomach sickness, fatigue, confusion, or frequent urinary urges. If Vraylar side effects are seen you may want to stop use and speak to your doctor again to discuss bipolar disorder and schizophrenia treatment medication alternatives.
Frequently Asked Questions about Vraylar
What is Vraylar?
Vraylar is the brand name for cariprazine, an atypical antipsychotic. In the current U.S. labeling, it is approved for schizophrenia, bipolar I manic or mixed episodes, bipolar I depression in adults, and as add-on treatment to an antidepressant for major depressive disorder in adults; it also has certain pediatric approvals for schizophrenia and bipolar I manic or mixed episodes.
How is Vraylar usually taken?
Vraylar is taken by mouth once daily and can be taken with or without food. For major depressive disorder, it is used together with an antidepressant rather than by itself.
What doses are common?
In adults, schizophrenia and bipolar mania commonly start at 1.5 mg once daily, while bipolar depression and adjunctive treatment for major depressive disorder also start at 1.5 mg once daily, with increases based on response and tolerability. The maximum recommended dose is 6 mg daily for schizophrenia and bipolar mania, and 3 mg daily for bipolar depression or adjunctive treatment of major depressive disorder.
Why can Vraylar dose changes take time to show?
Cariprazine and its active metabolites stay in the body for a long time, so blood levels and clinical effects can build gradually. The label notes that dose changes may not be fully reflected for several weeks, and the major active metabolite can take about 4 to 8 weeks to approach steady state.
What are the most common side effects?
Common side effects differ somewhat by condition, but akathisia or restlessness and extrapyramidal symptoms are among the most frequent. Nausea, insomnia, fatigue, constipation, dizziness, increased appetite, somnolence, and indigestion can also occur.
Can Vraylar cause weight gain or metabolic problems?
Yes. Like other atypical antipsychotics, Vraylar can cause weight gain and metabolic changes such as high blood sugar or diabetes and abnormal lipids, so baseline and periodic monitoring is recommended.
What are the most important serious warnings?
Vraylar carries a boxed warning that elderly patients with dementia-related psychosis treated with antipsychotics have an increased risk of death, and it is not approved for that use. It also carries a warning about suicidal thoughts and behaviors in pediatric and young adult patients when used as an antidepressant-related treatment, and other serious risks include neuroleptic malignant syndrome, tardive dyskinesia, low white blood cells, orthostatic hypotension, falls, seizures, and impaired thinking or motor function.
What medicines interact with Vraylar?
Strong or moderate CYP3A4 inhibitors can raise cariprazine exposure, so the Vraylar dose often needs to be reduced when they are used together. Concomitant use with CYP3A4 inducers is not recommended because the overall effect on the drug and its active metabolites is unclear.
What should you do if you miss a dose?
Take the missed dose as soon as you remember it, but skip it if it is almost time for the next dose. Do not take two doses at the same time to make up for a missed dose.
What should people know about pregnancy or breastfeeding?
The label says there are no adequate human pregnancy data to define drug-related risk, but based on animal data Vraylar may cause fetal harm, and babies exposed during the third trimester may have extrapyramidal or withdrawal symptoms after birth. Human milk data are lacking, although cariprazine is present in rat milk, so breastfeeding decisions should weigh the need for treatment and possible infant risk.
