Vraylar

Vraylar is a prescription medication used to treat acute manic or mixed episodes associated with bipolar I disorder and is used to treat schizophrenia in adults.

It belongs to a group of drugs called atypical antipsychotics. These work by changing the activity of certain natural substances in the brain.

This medication comes in capsule form and is usually taken once a day. 

Common side effects of Vraylar include extrapyramidal symptoms, such as tremor, slurred speech, involuntary muscle movements, urge to move (akathisia), and restlessness.

Vraylar can also cause drowsiness. Do not drive or operate heavy machinery until you know how Vraylar affects you.

Vraylar is a prescription medication used to treat acute manic or mixed episodes associated with bipolar I disorder and is used to treat schizophrenia in adults. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Actavis Pharma, Inc.

Serious side effects have been reported with Vraylar. See the “Vraylar Precautions” section.

Common side effects of Vraylar include the following:

• extrapyramidal symptoms, such as tremor
• slurred speech
• involuntary muscle movements
• urge to move (akathisia)
• indigestion (dyspepsia)
• vomiting
• restlessness
• drowsiness

This is not a complete list of Vraylar side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)

Serious side effects have been reported with Vraylar including the following:

• Stroke (which can be fatal) in elderly people with dementia.
• Neuroleptic Malignant Syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms of this life-threatening nervous system disorder:
  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in pulse, heart rate, and blood pressure
• Tardive Dyskinesia (TD):  Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking Vraylar. Tardive dyskinesia may also start after you stop taking Vraylar.
• Late-Occurring Adverse Reactions: Adverse events may first appear several weeks after initiation of Vraylar, probably because plasma levels of cariprazine and its major metabolites accumulate over time. Monitor for adverse reactions and patient response for several weeks after starting Vraylar and after each dosage increase. Consider reducing the dose or discontinuing the drug.
• Metabolic Changes: Atypical antipsychotics have caused metabolic changes, such as:

1) High blood sugar Diabetes Mellitus: Increases in blood sugar can happen in some people who take Vraylar. Call your healthcare provider if you have any of these symptoms of high blood sugar while taking Vraylar:

• feel very thirsty
• need to urinate more than usual
• feel very hungry
• feel weak or tired
• feel sick to your stomach
• feel confused, or your breath smells fruity

2) Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Your doctor will monitor your lipids before or soon after starting an antipsychotic and will monitor periodically during treatment.

3) Weight Gain: Weight gain has been reported in patients taking medicines like Vraylar, so you and your healthcare provider should check your weight regularly. 

• Decreases in blood cell counts. Your doctor will monitor your blood counts. Your doctor may need to discontinue your medication if your blood counts decrease too much. 
• Decreased blood pressure: You may feel lightheaded or faint when you rise too quickly from a sitting or lying position
• Falls: Vraylar may increase risk of falls, which could cause fractures or other injuries
• Seizures
• Impaired judgment, thinking, and motor skills: Do NOT drive or use dangerous machinery until you know how Vraylar affects you. Vraylar may make you drowsy
• Increased body temperature: Vraylar may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm
• Difficulty swallowing: Vraylar and medicines like it have been associated with difficulty swallowing. 

Vraylar can cause drowsiness. Do not drive or operate heavy machinery until you know how Vraylar affects you.

Do not take Vraylar if you are allergic to Vraylar or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vraylar, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Vraylar, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Vraylar or to any of its ingredients
• have diabetes
• have high cholesterol
• have a history of seizures
• ever had problems swallowing
• have or have a history of tardive dyskinesia (TD) or Neuroleptic Malignant Syndrome (NMS)
• have dementia
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Based on animal data, Vraylar may cause fetal harm. There are no available data on Vraylar use in pregnant women to inform any drug associated risks for birth defects or miscarriage. Vraylar can cause extrapyramidal symptoms and/or withdrawal symptoms in a neonate if taken in the third trimester. 

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this medication during pregnancy. For more information, contact the National Pregnancy Registry for atypical antipsychotics at 1-866-961-2388.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Vraylar crosses into human milk. It is also not known how Vraylar effects the breastfed infant or its effects on milk production. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Vraylar.

Take Vraylar exactly as prescribed.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose range of Vraylar (cariprazine) for the treatment of bipolar I disorder in adults is 3 to 6 mg/day.

The recommended dose range of Vraylar (cariprazine) for the treatment of schizophrenia in adults is 1.5 to 6 mg/day.

If you take too much Vraylar, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at 20 C to 25 C (68 F to 77 F)
• Keep this medication and all other medications out of the reach of children.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for treatment of patients with dementia-related psychosis.