WARNING

Vraylar (cariprazine) is an antipsychotic medication used to treat schizophrenia and bipolar disorder. Like any medication, Vraylar comes with potential risks and side effects. It’s important to note that individual responses to medications can vary, and not everyone will experience these effects. Here are some potential risks associated with taking Vraylar:

• Common Side Effects: The most common side effects include restlessness, extrapyramidal symptoms (involuntary movements), indigestion, and sleepiness. Weight gain and metabolic changes may occur.
• Neurological Effects: Vraylar can affect the central nervous system, potentially leading to symptoms like drowsiness, dizziness, and difficulty concentrating. It may also cause extrapyramidal symptoms such as tremors, muscle stiffness, and abnormal movements.
• Cardiovascular Effects: Antipsychotic medications, including Vraylar, may be associated with changes in blood pressure and heart rate.
• Metabolic Effects: Weight gain and changes in metabolic parameters, such as increased blood sugar and cholesterol levels, have been reported with Vraylar.
• Orthostatic Hypotension: Vraylar may cause a drop in blood pressure upon standing, leading to dizziness or fainting.
• Swallowing Difficulties: Some people may experience difficulty swallowing, which can be serious. This risk is higher in elderly individuals with dementia-related psychosis.
• Increased Mortality in Elderly Patients with Dementia: Elderly patients with dementia-related psychosis treated with antipsychotic drugs like Vraylar have an increased risk of death.
• Adverse Reactions in Pregnancy: The use of Vraylar during pregnancy may have potential risks, and it should be used only if the potential benefits justify the potential risks to the fetus.

It’s crucial to discuss any concerns or potential side effects with your healthcare provider before starting or discontinuing any medication. Your healthcare provider can provide personalized information based on your medical history and specific health needs. If you are experiencing any unexpected or severe side effects while taking Vraylar, it’s essential to seek medical attention promptly.

Why is this medication prescribed?

Vraylar (cariprazine) is prescribed primarily for the treatment of schizophrenia and bipolar disorder. Here’s a brief overview of its uses and recommended usage:

• Schizophrenia: Vraylar is used to treat the symptoms of schizophrenia, a mental health disorder characterized by distorted thinking, hallucinations, and a diminished ability to engage in everyday activities.
• Bipolar Disorder: Vraylar is also indicated for the treatment of manic or mixed episodes associated with bipolar I disorder. Bipolar disorder involves periods of mania (elevated mood, increased energy) and depression.

How should this medicine be used?

Here are some general guidelines:

• Dosage: The recommended dosage of Vraylar can vary depending on the specific condition being treated and individual patient factors. It is typically initiated at a low dose and adjusted by the healthcare provider as needed.
• Administration: Vraylar is usually taken orally, with or without food. It comes in the form of tablets or capsules.
• Consistency in Use: It’s important to take Vraylar consistently as prescribed by the healthcare provider. Missing doses or stopping the medication abruptly can lead to a recurrence of symptoms or withdrawal effects.
• Regular Monitoring: Patients taking Vraylar may be monitored regularly by their healthcare provider to assess the effectiveness of the medication and to check for any potential side effects or changes in health.
• Caution with Certain Populations: Special caution is advised when using Vraylar in elderly patients with dementia-related psychosis, as there is an increased risk of adverse effects.
• Pregnancy and Lactation: Pregnant individuals or those planning to become pregnant should discuss the potential risks and benefits of Vraylar with their healthcare provider. Similarly, breastfeeding individuals should consult their healthcare provider before using Vraylar.
• Individualized Treatment: Treatment with Vraylar is highly individualized, and the choice to prescribe it is based on a careful evaluation of the patient’s medical history, symptoms, and overall health.

It’s crucial for individuals prescribed Vraylar to communicate openly with their healthcare provider, reporting any side effects, concerns, or changes in symptoms. Only a qualified healthcare professional can determine the appropriate use of Vraylar based on an individual’s specific circumstances.

Other uses for this medicine

Vraylar (cariprazine) is primarily indicated for the treatment of schizophrenia and bipolar disorder. It’s important to note that medication uses and guidelines can change over time, so it’s crucial to consult with a healthcare professional or check more recent sources for the latest information.

What special precautions should I follow?

Regarding special precautions for Vraylar, here are some general considerations:

• Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs, including Vraylar, have an increased risk of death. Vraylar is not approved for the treatment of patients with dementia-related psychosis.
• Neuroleptic Malignant Syndrome (NMS): NMS is a potentially life-threatening condition associated with antipsychotic medications. Patients should be monitored for signs and symptoms of NMS, which include hyperthermia, muscle rigidity, altered mental status, and autonomic dysfunction.
• Tardive Dyskinesia: Antipsychotic medications, including Vraylar, may cause tardive dyskinesia, a syndrome characterized by involuntary movements of the face and tongue. The risk increases with long-term use.
• Orthostatic Hypotension: Vraylar can cause orthostatic hypotension, which may lead to dizziness or fainting, especially during the initial dose titration.
• Leukopenia, Neutropenia, and Agranulocytosis: Decreases in white blood cell count, including leukopenia, neutropenia, and agranulocytosis, have been reported with antipsychotic medications. Regular monitoring of blood cell counts is recommended.
• Swallowing Difficulties: Difficulty swallowing has been reported with antipsychotic medications, particularly in elderly patients with dementia. This may lead to aspiration pneumonia. Caution is advised in patients at risk for aspiration.
• Pregnancy and Lactation: The use of Vraylar during pregnancy should be discussed with a healthcare provider. The potential risks and benefits should be carefully considered. It is not recommended for use during breastfeeding.
• Concomitant Medications: Inform your healthcare provider about all the medications, including over-the-counter drugs and supplements, that you are taking, as some medications may interact with Vraylar.
• Alcohol: Limit alcohol intake while taking Vraylar, as alcohol may enhance the sedative effects of the medication.

These are general precautions, and individual cases may vary. It’s crucial to discuss any specific concerns or conditions with your healthcare provider before starting or adjusting the dosage of Vraylar. They can provide personalized guidance based on your medical history and individual health needs.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Vraylar. However, maintaining a healthy and balanced diet is generally advisable, especially considering potential side effects such as weight gain and metabolic changes that can occur with antipsychotic medications.

What should I do if I forget a dose?

If you forget to take a dose of Vraylar, follow these general guidelines:

• If it’s close to the next scheduled dose: Skip the missed dose and take the next one at the regularly scheduled time.
• If there is ample time before the next dose: Take the missed dose as soon as you remember. However, if it’s close to the next scheduled dose, do not double the dose to make up for the missed one.
• If you are unsure or have concerns: Contact your healthcare provider for guidance on what to do if you miss a dose.

What side effects can this medication cause?

Vraylar (cariprazine) can cause various side effects, and individual responses may vary. It’s important to note that not everyone will experience these side effects, and some individuals may experience side effects that are not listed here. Common side effects of Vraylar include:

• Extrapyramidal Symptoms (EPS): These include symptoms such as tremors, muscle stiffness, and abnormal movements. These symptoms can be associated with the use of antipsychotic medications.
• Akathisia: This is a feeling of inner restlessness that can manifest as an inability to sit still or a constant need to move.
• Insomnia: Difficulty sleeping or disturbances in sleep patterns may occur.
• Nausea: Some individuals may experience nausea as a side effect of Vraylar.
• Vomiting: Vomiting is a less common side effect but may occur in some individuals.
• Indigestion: Gastrointestinal symptoms such as indigestion or upset stomach may occur.
• Weight Gain: Weight gain is a potential side effect of Vraylar. Monitoring weight and making lifestyle adjustments may be necessary.
• Metabolic Changes: Changes in blood sugar levels and lipid profile, potentially leading to metabolic changes, have been reported with antipsychotic medications.
• Orthostatic Hypotension: Vraylar may cause a drop in blood pressure upon standing, leading to dizziness or fainting.
• Hyperprolactinemia: Increased levels of the hormone prolactin may occur, potentially leading to side effects such as menstrual irregularities or breast enlargement in both males and females.
• Swallowing Difficulties: Some individuals, particularly elderly patients with dementia, may experience difficulty swallowing.
• Increased Mortality in Elderly Patients with Dementia: Elderly patients with dementia-related psychosis treated with antipsychotic drugs, including Vraylar, have an increased risk of death.

It’s important to report any unusual or severe side effects to your healthcare provider promptly. Additionally, it’s crucial to attend regular follow-up appointments to monitor for potential side effects and assess the overall effectiveness of the medication. This list is not exhaustive, and the prescribing healthcare provider will provide comprehensive information on potential side effects based on your individual health history and needs.

What should I know about storage and disposal of this medication?

Storage and Disposal of Vraylar:

• Storage:
  • Store Vraylar (cariprazine) at room temperature, away from moisture and heat.
  • Keep the medication in its original packaging or container to protect it from light.
  • Avoid storing Vraylar in the bathroom.
• Disposal:
  • Dispose of unused or expired medication in accordance with local regulations.
  • Do not flush medications down the toilet or pour them into drains unless instructed to do so. Check with your local pharmacy or healthcare provider for proper disposal options.

In case of emergency/overdose

If you suspect an overdose or experience severe symptoms, seek emergency medical attention or contact your local poison control center immediately. Symptoms of overdose may include:

• Extreme drowsiness
• Uncontrolled movements
• Agitation
• Seizures
• Loss of consciousness

What other information should I know?

• Regular Monitoring: Attend regular follow-up appointments with your healthcare provider to monitor the effectiveness of Vraylar and check for any potential side effects.
• Blood Tests: Your healthcare provider may conduct periodic blood tests to monitor factors such as white blood cell count, blood sugar levels, and lipid profile.
• Informing Healthcare Providers: Inform all healthcare providers involved in your care about the use of Vraylar, including dentists and emergency medical professionals. Provide a list of all medications, including over-the-counter drugs and supplements.
• Alcohol and Other Substances: Limit alcohol intake, as alcohol may enhance the sedative effects of Vraylar. Discuss the use of other substances with your healthcare provider.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. The use of Vraylar during pregnancy should be carefully considered, and the risks and benefits should be discussed with your healthcare provider.
• Dizziness: Vraylar may cause dizziness, especially when standing up quickly. Take precautions to avoid falls or injury.
• Driving and Operating Machinery: Be cautious when driving or operating machinery, especially during the initial stages of treatment, as Vraylar can cause drowsiness and affect alertness.
• Follow Prescribing Instructions: Take Vraylar exactly as prescribed by your healthcare provider. Do not adjust the dose or stop taking the medication without consulting your healthcare provider.

Always follow the guidance provided by your healthcare provider and the medication’s prescribing information. If you have specific concerns or questions about Vraylar, discuss them with your healthcare provider for personalized advice based on your health history and individual circumstances.