The approval of medicines called second-generation antipsychotics has allowed bipolar I and other associated conditions to be treated. A person with bipolar I disorder can go through various mood swings, also known as episodes, that may require them to take one or more medicines at the same time during different episodes.
Vraylar was approved in 2015 and has allowed people with bipolar I disorder to take a medicine that can help control manic, depressive, and mixed episodes.
How Does Vraylar Work for Bipolar I?
Bipolar disorder causes severe changes in mood and energy that can cause unpredictable high (manic) and low (depressive) mood swings. There are two types of bipolar disorder: bipolar I and bipolar II. A person with bipolar I has experienced at least one episode of mania (also called a manic episode). Each person with bipolar I disorder has differences in how severe or less severe their high and low mood swings are and for how long they last. There is no cure for bipolar disorder, but medicines can help control symptoms and improve quality of life.
Vraylar is used to treat people with manic, depressive, and mixed episodes (symptoms of both mania and depression occurring at the same time). The active ingredient in Vraylar is cariprazine. Vraylar is a second-generation antipsychotic, which is a class of medicines used to treat psychiatric conditions. Second-generation antipsychotics are different from first-generation antipsychotics because they are less likely to produce movement-related side effects (extrapyramidal symptoms) such as restlessness and tremor.
The exact way that Vraylar works is not known. But the medicine is designed to alter chemicals in the brain (serotonin and dopamine) that affect mood.
How Do I Take It?
Vraylar comes as 1.5-milligram, 3-milligram, 4.5-milligram, and 6-milligram capsules that you take by mouth once daily, with or without food. Depending on if you are experiencing a manic or depressive mood, the dose you take may change. Always take Vraylar as prescribed by your health care provider.
For manic or mixed episodes, Vraylar 1.5 milligrams will usually be prescribed on day 1 (to start your treatment) and increased to 3 milligrams starting on day 2. Your health care provider may continue you on 3 milligrams or slowly increase your dose (maximum daily dose is 6 milligrams) depending on how well you are tolerating the medicine.
For depressive episodes, 1.5 milligrams will usually be prescribed to you on day 1 to start your treatment. Your health care provider may increase your dose on day 15 to 3 milligrams (maximum daily dose) depending on how well you are tolerating the medicine.
How Was It Studied for Bipolar I?
Three clinical studies were done in people with bipolar I with manic or mixed episodes to see if Vraylar was safe and effective. Three additional studies were done in people with bipolar I with depressive episodes to see if Vraylar was safe and effective.
Three studies that looked at people with manic or mixed episodes of bipolar I compared Vraylar to placebo. The doses of Vraylar that were given across all three studies was between 3 and 12 milligrams per day. People in the study were between 18 through 65 years of age, with the average age among all three studies being 39. People in the study were classified as White Americans, African Americans, Asian Americans, or as “Other,” where their race wasn’t specified. The studies looked at the change in Young Mania Rating Scale (YMRS) score from baseline to 3 weeks. The YMRS looks at the degree of manic symptoms based on an 11-point scale. The higher the score, the more severe the manic symptoms.
Three studies that looked at people with depressive episodes of bipolar I compared Vraylar to placebo. The doses of Vraylar that were given across all three studies were between 0.75 and 3 milligrams per day. People in the study were between 18 and 65 years old, with the average age among all three studies being 43. People in the study were classified as White Americans, African Americans, Asian Americans, those classified as “Other,” where their race wasn’t specified, or “Multiple,” where people reported two or more races. All three studies looked at the Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline to 6 weeks. The MADRS looks at the degree of depressive symptoms based on a 10-point scale. The higher the score, the more severe the depression symptoms.
Across all six studies, Vraylar was effective regardless of age, sex, or race. Your results may differ from what was seen in clinical studies.
What Were the Results?
Treatment of manic/mixed episodes: When compared to placebo, people taking Vraylar had lower YMRS scores from baseline to week 3. This means that people taking Vraylar had improved manic or mixed episode symptoms compared to placebo. Higher doses (over 6 milligrams per day) did not show better treatment compared to the lower doses, but instead had higher side effects.
Treatment of depressive episodes: When compared to placebo, people taking Vraylar 1.5 milligrams and 3 milligrams had lower MADRS scores (improving depression symptoms) from baseline to week 6. This means that people taking Vraylar had improved depression symptoms compared to placebo.
How Long Does It Take Vraylar to Work?
Vraylar will start to work gradually, so it is important to take it every day and to not stop taking the medicine unless told to by your health care provider. Because of this, it may take some time to see your symptoms improve, including stability in your mood. Doing things like using a pillbox or setting a reminder on your phone can help you remember to take your medicine and minimize your chances of missing a dose. Depending on your symptoms, your health care provider may decide to increase your dose, add additional medicines, or switch you to a different medicine.
During the first few months of starting Vraylar and after having your dose change, the risk of suicidal thoughts and actions increases. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your health care provider right away if you have any of the following symptoms:
- New or increased thoughts of suicide or death
- Suicide attempt
- New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior
How Can I Manage Side Effects?
The most common side effects seen with Vraylar are:
- Involuntary movements that you cannot control (extrapyramidal symptoms) including shakiness, stiffness, or jerkiness
- A movement disorder that makes it hard for you to sit still (akathisia)
- Upset stomach (or indigestion)
- Vomiting
- Drowsiness (or sleepiness)
- Feeling restless
- Nausea
Vraylar stays in your body for a long time. Some side effects may not happen right away but may happen after a few weeks, especially if your Vraylar dose has increased.
Talk to your health care provider if you are experiencing extrapyramidal symptoms, akathisia, or feeling restless due to Vraylar. Your health care provider may lower the dose of your medicine, prescribe medicine to treat your symptoms, or switch you to another medicine.
If you are experiencing nausea, upset stomach, or vomiting, make sure you are drinking plenty of water to prevent yourself from becoming dehydrated, and call your health care provider if your symptoms are not getting any better. To help reduce these symptoms, eat bland foods such as crackers or bread, avoid greasy foods and strong smells, eat smaller meals, and eat slowly.
Vraylar can cause drowsiness in some people. Do not drive or do other activities that require alertness or coordination until you know how Vraylar affects you.
This is not a complete list of side effects of Vraylar. Talk to your doctor if side effects don’t go away or become bothersome. You can report side effects to the FDA at 800-FDA-1088.
What Type of Drug Interactions Can Happen?
Other medicines may alter the blood levels of Vraylar. This may increase the risk of side effects from Vraylar or can cause Vraylar to not work as well. Talk to your health care provider about all the prescription medicines, over-the-counter medicines, and supplements that you are taking. Your health care provider will decide if they need to modify any of the medicines that you are taking or modify the dose of Vraylar that you are taking.
Is There a Cost-Savings Program?
There is a savings card available from the manufacturer that may allow you to pay $0 for your first two 30-day supply prescriptions or $5 per 30-day refill or 90 day supply. Whether you are eligible depends on your insurance coverage. You can find out more at www.vraylarhcp.com/vraylar-savings-card-office-support or by calling 800-678-1605.
