Vraylar (cariprazine) is an atypical antipsychotic medication prescribed to adults for managing various mental health conditions, including:
- Major Depressive Disorder (MDD), used alongside antidepressant medications
- Manic or mixed episodes and depressive episodes related to Bipolar I Disorder
- Schizophrenia
Like other atypical antipsychotic drugs, Vraylar can cause metabolic changes that cause weight gain. Weight gain has been reported with VRAYLAR. However, each person’s experience with Vraylar differs.
Vraylar and Weight Gain: What the Studies Suggest
Clinical studies have reported weight gain as one of Vraylar’s side effects. It is important to note that an international panel of clinicians with real-world experience with Vraylar reported that weight gain is not a particularly problematic side effect of Vraylar.
The following table shows the weight gain that people experienced in various studies of Vraylar for bipolar disorder and schizophrenia. Weight is expressed in pounds (lb). The dosages, where available, are in milligrams (mg).
Real-World Data on Vraylar and Weight
A retrospective analysis of electronic medical records from patients who were prescribed cariprazine for the treatment of BP-I depression, BP-I mania/mixed, schizophrenia, or as an adjunctive treatment for MDD. This retrospective observational study was conducted using medical/pharmacy claims data and linked electronic medical records obtained from Symphony Health, an ICON plc Company, Integrated Dataverse® (IDV) from March 1, 2015, to October 31, 2018.
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The study consisted of a 12-month pre-treatment (baseline) period before the initiation of cariprazine (index date) followed by at least 3 months of continuous clinical activity, defined as consecutive quarters with ≥ 1 pharmacy, medical, or hospital claim (Fig. 1). Adult patients (≥ 18 years) with at least 2 cariprazine fills (first dispensing = index date) and continuous clinical activity for at least 12 months pre-index and at least 3 months post-index were included in the analysis. Patients were required to have a diagnosis of BP-I depression, BP-I mania/mixed, schizophrenia, or MDD (Supplemental Table 1 and 2); patients with MDD must have shown evidence of adjunctive cariprazine use (off-label during this study period).
Annual linear trajectories for weight, BMI, systolic blood pressure, and diastolic blood pressure were estimated using all measurements recorded during the pre-index (baseline) and cariprazine on-treatment period for patients across all indications combined (BP-I depression, BP-I mania/mixed, MDD, and schizophrenia).
Of 74,766 patients with a cariprazine dispensing, a total of 612 met the full study inclusion criteria and had baseline and on-treatment data available for weight and BMI (Fig. 2). Of these patients, 206 (34%) had a diagnosis of MDD and were using cariprazine adjunctively, 172 (28%) had a diagnosis of BP-I depression, 159 (26%) had a diagnosis of BP-I mania/mixed, and 75 (12%) had a diagnosis of schizophrenia. The mean (SD) on-treatment period for was 219 (185) days; the average patient age was 43.4 years, and 75.2% were female. Mean weight at baseline was 95.1 kg, and more than 80% of patients had a baseline BMI categorizing them as overweight (BMI of 25 to < 30 kg/m2) or obese (BMI ≥ 30 kg/m2).
These patients gained an estimated + 3.55 kg/year during the baseline period (estimated annual linear weight trajectory: + 3.55 [95% CI 2.38, 4.59] kg/y), which was reduced to an estimated + 0.91 kg/year after cariprazine initiation (estimated annual linear weight trajectory: + 0.91 [− 1.17, 2.82] kg/y).
Before cariprazine initiation, the estimated annual linear weight trajectory for patients with at least 1 weight measurement up to 3 months on treatment (n = 531, 87%) was + 3.11 (1.97, 4.22) kg/y. After cariprazine initiation, the estimated annual linear weight trajectory up to 3 months on treatment was + 5.05 (1.11, 9.34) kg/y, corresponding to an average weight increase of + 1.26 kg over the first 3 months of cariprazine treatment. In patients with at least 1 weight measurement up to 6 months on treatment (n = 594, 97%), the estimated annual linear weight trajectory was + 3.10 (2.00, 4.14) kg/year prior to cariprazine initiation and + 3.65 (0.84, 6.47) kg/year after cariprazine initiation, corresponding to an average weight increase of + 1.83 kg over the first 6 months of cariprazine treatment (Fig. 4A).
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Why Atypical Antipsychotics May Cause Weight Gain
Antipsychotic-related weight gain is thought to be linked to how these drugs interact with the brain’s neurotransmitter receptors, particularly the histamine H1, serotonin 5-HT2C, and muscarinic acetylcholine receptors. Medications like olanzapine and clozapine that strongly block these receptors often lead to significant increases in appetite and weight. In contrast, Vraylar has weak activity at these sites.
Monitoring Your Weight While Taking Vraylar
Knowing this, you and your healthcare professional should monitor your weight. Your doctor should record your weight at the beginning of treatment and check it often throughout treatment.
The Importance of Exercise During Vraylar Treatment
It’s well known that exercise helps maintain weight. But even so, the manufacturer of Vraylar has some cautions to be aware of concerning exercise during treatment.
Strenuous exercise contributes to an increase in core body temperature, which can rise as high as 104°F. Other factors that contribute to an increase in core body temperature include: exposure to extreme heat, dehydration, anticholinergic medications, which treat various conditions such as chronic obstructive pulmonary disease (COPD) and urinary incontinence. Some of these medications are available by prescription or over the counter (OTC).
Vrayler is an atypical antipsychotic drug. This type of drug can disrupt the body’s ability to reduce its core body temperature. So it’s important not to overheat the body.
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That means while exercise is okay during Vraylar treatment, you should be mindful of how vigorously you’re exercising. Follow these guidelines for exercising during Vraylar treatment:
- do not exercise too much
- do not become too hot
- do not become dehydrated
- drink plenty of water
Talk with your doctor to understand how you can best incorporate exercise during Vraylar treatment. They also may have recommendations on nutrition that can help you manage your weight. Also, tell them all prescription and OTC medications you take so they’re aware if you’re taking an anticholinergic drug.
Other Common Side Effects of Vraylar
Vraylar (cariprazine) is a once-daily oral medication that may be used to treat bipolar disorder, depression, or schizophrenia. Common side effects of Vraylar include:
- Movement disorders (extrapyramidal symptoms)
- Stomach problems (such as indigestion, nausea, vomiting, or constipation)
- Sleep problems such as drowsiness, dizziness, feeling sleepy all the time, fatigue, or trouble sleeping
- Increased appetite and weight gain
Managing Side Effects
If you have problems with side effects from Vraylar, talk with your doctor or pharmacist. They can discuss ways to manage side effects or other available treatment options. Do not stop taking Vraylar without consulting your doctor first.
Increased risk of death in older adults who have dementia-related psychosis
Vraylar has a boxed warning for an increased risk of death when taken by adults ages 65 years and over with dementia-related psychosis. Boxed warnings alert patients and doctors about potentially dangerous drug effects.
Older adults with psychosis related to dementia have a higher risk of death when treated with antipsychotic medications, including Vraylar.
Vraylar is not FDA approved for treating psychosis caused by dementia in older adults.
Suicidal thoughts and behaviors
Vraylar has a boxed warning for the risk of suicidal thoughts and behaviors in children and young adults under age 25 years.
Antidepressants may increase the risk of suicidal thoughts and behaviors in children and young adults. Vraylar is a type of antipsychotic drug. But when Vraylar is used to treat bipolar depression or major depressive disorder (MDD), it may act similarly to antidepressants. (Note that Vraylar is taken together with an antidepressant for treating MDD.)
Vraylar is not approved for use in people younger than age 18 years. However, whatever your age, your doctor will typically monitor you while you take drugs such as Vraylar. They’ll watch for changes in thinking, including suicidal thoughts or behaviors.
During your Vraylar treatment, watch for changes in your thoughts and behaviors. You can also ask friends and loved ones to monitor your symptoms. This is especially important when you first start taking the medication and whenever your dose is adjusted. If you or someone else notices any changes, talk with your doctor immediately or get medical attention right away.
Nausea
Nausea is a potential mild side effect of Vraylar. Nausea was among the more common side effects reported by people using the drug in clinical trials. But most people taking Vraylar didn’t experience it.
For most people who experience nausea from Vraylar, this side effect goes away on its own after a few days.
If you experience nausea that doesn’t go away after a few days while taking Vraylar, talk with your doctor. They’ll typically want to see you for an appointment so they can find out whether anything else could be causing the nausea. If your doctor determines that the nausea is a side effect of Vraylar, they may suggest ways to ease it. But if the nausea is affecting your daily life, your doctor will typically recommend a different medication for your condition.
Insomnia
Insomnia is a possible side effect of taking Vraylar. Insomnia is a condition in which you have difficulty sleeping. People who took Vraylar reported symptoms such as: difficulty falling asleep or staying asleep, trouble falling asleep after waking in the middle of the night or very early in the morning.
If you experience insomnia while taking Vraylar, talk with your doctor. They may recommend different options to manage this side effect, such as taking a sleep aid.
Your doctor may also recommend changes to your sleep hygiene, such as avoiding TV and phones before bed. Or they may suggest switching to a different drug for your condition.
Uncontrolled body movements
Although rare, taking Vraylar can cause a serious side effect called tardive dyskinesia. This condition is characterized by repetitive, uncontrolled body movements.
Symptoms of tardive dyskinesia can include repeated, unintentional: chewing motions, jerky movements of your arms, legs, or torso, lip smacking, puffing air into your cheeks, tongue twisting.
Tardive dyskinesia symptoms may go away after you stop taking Vraylar. But this side effect can sometimes be permanent.
It isn’t possible to predict who will develop tardive dyskinesia with Vraylar. But it’s believed that older adults have a higher risk. Both the risk of developing tardive dyskinesia and the risk of it becoming permanent increase the longer you take Vraylar.
Taking a higher dose can increase your risk, but tardive dyskinesia has occurred in people taking low doses, although this is rare. In addition, it’s possible to develop tardive dyskinesia after stopping Vraylar treatment because the drug stays in your body for a long time.
Your doctor will monitor you while you’re taking Vraylar to see whether the drug is effective and whether you have any side effects. They’ll try to prescribe the lowest dose that works for you.
While taking Vraylar, watch for symptoms of tardive dyskinesia and talk with your doctor if you develop any of them. They’ll likely want to discuss with you the risks and benefits of continuing to take the drug. For some people, Vraylar is the best long-term treatment for their condition, even when tardive dyskinesia occurs. For other people, tardive dyskinesia may be a reason to stop taking Vraylar and switch to a different medication.
Precautions to Consider Before Taking Vraylar
Before taking Vraylar, discuss your health history with your doctor. Vraylar may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
- Type 2 diabetes
- High or low blood pressure
- High cholesterol
- Liver or kidney problems
- Low white blood cell counts
- Seizure disorder
- Previous allergic reaction to this or a similar drug
- Pregnancy or breastfeeding
- Alcohol consumption