General Information
Manufacturer: Abbvie
Medical Name: Cariprazine
Purpose: Vraylar is a prescription medicine used along with antidepressant medicines to treat major depressive disorder (MDD) in adults.
Side Effects
| Side Effect | Percentage |
|---|---|
| Movement problems (Extrapyramidal symptoms) | Up to 45% in some studies |
| Akathisia (inability to sit still/restlessness) | Up to 21% |
| Nausea | Up to 13% |
| Vomiting | Up to 10% |
| Insomnia (trouble sleeping) | Up to 13% |
| Somnolence (sleepiness/drowsiness) | Up to 10% |
| Constipation | Up to 11% |
| Weight gain | Up to 17% |
| Headache | Up to 18% |
| Restlessness | Up to 7% |
| Dyspepsia (indigestion) | Up to 9% |
| Dizziness | Up to 5% |
Serious but Less Common Side Effects
| Side Effect | Description |
|---|---|
| Neuroleptic Malignant Syndrome (NMS) | A rare but potentially fatal condition involving high fever, severe muscle stiffness, confusion, and rapid or irregular heartbeat. The incidence rate is generally less than 1% for all antipsychotics. |
| Tardive Dyskinesia (TD) | Uncontrolled, jerky movements of the face, tongue, or other body parts. This is an uncommon side effect of Vraylar, occurring in less than 1% of patients in clinical trials, but can be irreversible. |
| Suicidal Thoughts or Actions | The risk for this is higher in children and young adults, especially within the first few months of treatment. |
| Increased Mortality in Elderly Patients with Dementia | Vraylar is not approved for use in elderly patients with dementia-related psychosis due to an increased risk of death. |
| Metabolic Changes | These include high blood sugar (hyperglycemia) and diabetes, which can be life-threatening if untreated. |
| Low White Blood Cell Count | This can increase the risk of infection. Your healthcare provider may monitor your blood count |
Preclusions To Starting Treatment
| Condition | Description |
| Hypersensitivity | Vraylar is contraindicated in patients with a history of an allergic reaction to cariprazine. Reactions can include rash, itching, hives, and swelling of the face, lips, tongue, or throat (angioedema). |
| Dementia-Related Psychosis in the Elderly | Vraylar is not approved for use in older adults (65 years and older) who have psychosis related to dementia, as studies have shown an increased risk of death and cerebrovascular adverse reactions (e.g., stroke) in this population when treated with antipsychotic medications. |
Preconditions Where Dosage Should Be Discussed Before Starting Treatment
| Precondition | Description |
|---|---|
| Cardiovascular and Cerebrovascular Conditions | History of heart problems, heart attack, stroke, or high blood pressure. |
| Metabolic Disorder - Diabetes and High Blood Sugar | Atypical antipsychotics can cause changes in blood sugar and fat levels. Patients with a history of diabetes or a family history of diabetes require close monitoring. |
| Metabolic Disorder - High Cholesterol/Triglycerides | Lipid levels should be checked before and during treatment. |
| Metabolic Disorder - Weight Gain | Weight should be monitored regularly. |
| Blood Disorders | A history of a low white blood cell count (leukopenia, neutropenia). |
| Neurological Conditions | A history of seizures or conditions that may lower the seizure threshold. |
| Liver or Kidney Disease | Use of Vraylar is generally not recommended in patients with severe liver or kidney impairment. |
| Body Temperature Regulation Issues | Conditions that may lead to overheating or dehydration (e.g., strenuous exercise, exposure to extreme heat) should be managed with caution. |
| Swallowing Difficulties (Dysphagia) | Antipsychotics have been associated with difficulty swallowing, which can increase the risk of aspiration. |