Vraylar

Vraylar (cariprazine) is used to treat types of bipolar I disorder, major depressive disorder (MDD), and schizophrenia. Vraylar works to improve depression symptoms in bipolar depression and major depressive disorder, and to improve psychiatric signs and symptoms in schizophrenia. Vraylar capsules are taken once a day.

Vraylar is thought to work by managing serotonin and dopamine levels, which are chemical messengers in the brain. Vraylar mechanism of action is believed to be by having a combination of partial agonist activity at central dopamine D₂, dopamine D₃, and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors. Vraylar is from the drug class of medications called atypical antipsychotics.

Vraylar became an FDA-approved medicine on September 17, 2015. Vraylar is now FDA-approved to treat:

• Schizophrenia in adults and adolescent patients 13 years and older
• Acute manic or mixed episodes associated with bipolar I in patients 10 years of age and older
• Depressive episodes associated with bipolar I disorder (bipolar depression) in adults
• Major depressive disorder (MDD) in adults, as an add-on treatment with an antidepressant therapy (ADT).

Take Vraylar once a day, with or without food.

General Vraylar dose information.

It may take several weeks before your symptoms improve. Keep using the medication as directed, and tell your doctor if your symptoms do not improve.

Take Vraylar exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

High doses or long-term use of Vraylar can cause a serious movement disorder that may not be reversible. The longer you use this medicine, the more likely you are to develop this disorder, especially if you are an older adult. Symptoms of this disorder include tremors or other uncontrollable muscle movements.

Tell your doctor if you have any changes in weight while taking this medicine.

Your blood pressure and heart rate will need to be checked often. You may also need frequent blood tests.

Vraylar capsules are available as 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, and 6 mg.

Boxed warnings:

• Vraylar is not approved for use in older adults with dementia-related psychosis due to an increased risk of death.
• Antidepressant medicines may increase suicidal thoughts or actions in some children and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

Other warning: Vraylar may disrupt the body’s ability to reduce core body temperature. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may cause an increase in body temperature. Use this medicine with caution in these circumstances.

This medicine also has warnings and precautions for neuroleptic malignant syndrome, tardive dyskinesia, late-occurring adverse reactions, metabolic changes, leukopenia, neutropenia, agranulocytosis, orthostatic hypotension and syncope, seizures, the potential for cognitive and motor impairment, and cerebrovascular adverse reactions in elderly patients with dementia-related psychosis.

Vraylar may cause metabolic changes. You should be monitored for high blood sugar levels (hyperglycemia) or diabetes mellitus, high blood cholesterol levels (dyslipidemia), and weight gain.

You should not use Vraylar if you are allergic to cariprazine.

Cariprazine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Vraylar is safe for you, tell your doctor if you have:

• heart disease, low or high blood pressure;
• a stroke or blood clot;
• high cholesterol or triglycerides (a type of fat in the blood);
• liver or kidney disease
• diabetes or high blood sugar, or a family history of diabetes or high blood sugar
• have or had a low white blood cell count
• have or had seizures (convulsions)
• if you are dehydrated

Taking antipsychotic medicine in the last 3 months of pregnancy may cause withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking Vraylar without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cariprazine on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

The most common Vraylar side effects are movement-related symptoms including tremors, uncontrolled body movements, and difficulty moving or slow movements (extrapyramidal symptoms), and restlessness or an inability to sit still (akathisia). Other common side effects are sleepiness, nausea, vomiting, indigestion, constipation, feeling tired, trouble sleeping, increased appetite, and dizziness. Because cariprazine builds up in the body over several weeks, some side effects may not appear until well after starting Vraylar or after a dose increase.

What are the common side effects of Vraylar?

In clinical trials, the most common Vraylar side effects (those reported in at least 5% of adults and at twice the rate of placebo) were extrapyramidal symptoms and akathisia. The side effects reported most often depend on the condition being treated. Common Vraylar side effects include:

• Movement and coordination: restlessness or an inability to sit still (akathisia), tremors, uncontrolled body movements, difficulty moving or slow movements (extrapyramidal symptoms)
• Sleep and energy: sleepiness (somnolence), trouble sleeping (insomnia), feeling tired (fatigue)
• Stomach and digestion: nausea, vomiting, indigestion (dyspepsia), constipation
• Appetite and weight: increased appetite, weight gain
• Other: dizziness

What are the serious side effects of Vraylar?

Vraylar has boxed warnings, the most serious type of FDA warning. Vraylar is not approved for older adults with dementia-related psychosis, because medicines like it raise the risk of death and stroke in this group. Vraylar, and the antidepressants it is combined with to treat major depressive disorder, can also increase suicidal thoughts and actions in people 24 years of age and younger, especially in the first few months of treatment or when the dose is changed.

Get emergency medical help if you have signs of an allergic reaction to Vraylar, such as hives, trouble breathing, or swelling of your face, lips, tongue, or throat. A rare, severe skin reaction (Stevens-Johnson syndrome) has also been reported.

Call your healthcare provider right away if you have:

• a severe nervous system reaction (neuroleptic malignant syndrome) with very stiff muscles, high fever, sweating, confusion, and a fast or uneven heartbeat
• uncontrolled muscle movements of the face, tongue, or body that may become permanent (tardive dyskinesia)
• high blood sugar with increased thirst, increased urination, dry mouth, or fruity breath odor
• changes in cholesterol, triglycerides, or weight (metabolic changes)
• signs of a low white blood cell count, such as fever, chills, sore throat, mouth sores, or frequent infections
• a light-headed or fainting feeling when you stand up (low blood pressure), or a fall
• a seizure
• trouble swallowing, or accidentally inhaling food or drink
• trouble controlling your body temperature, so that you feel too hot
• new or worsening depression or anxiety, or thoughts of self-harm

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

While you are taking Vraylar, you may be more sensitive to temperature extremes such as very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Strong and Moderate CYP3A4 inhibitors: Reduce Vraylar dose

CYP3A4 inducers: It is not recommended to take Vraylar with CYP3A4 inducers.

Taking Vraylar with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with cariprazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

With the Vraylar coupon, you may pay as little as $0 out-of-pocket for 30 and 90-day fills, if you qualify for the Vraylar coupon and your insurance covers this medicine. The coupon is sometimes called the Vraylar copay card or the Vraylar savings card. For more information on eligibility for the Vraylar coupon and savings, see Vraylar coupon: Do I qualify, and how much can I save? Or refer to the Vraylar Price Guide page.

Store Vraylar at room temperature, between 68°F to 77°F (20°C to 25°C). Protect the 3 mg and 4.5 mg capsules from light to help prevent color fading.

Manufactured by: Forest Laboratories Ireland Limited, Dublin, IE.

Distributed by: AbbVie Inc. North Chicago, IL 60064, USA

Active ingredient: cariprazine

Inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide.

Colorants include: black iron oxide, FD&C Blue 1, FD&C Red 3, FD&C Red 40, or yellow iron oxide.