Cariprazine

What is Cariprazine?

• Cariprazine (Vraylar) is an atypical antipsychotic use to treat schizophrenia and bipolar disorder in adults.

What are the uses of this medicine?

This medicine is used in adults:

• to treat schizophrenia
• for short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder
• to treat depressive episodes that happen with bipolar I disorder (bipolar depression)

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How does this medicine work?

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• Cariprazine (kar ip' ra zeen) is an atypical antipsychotic which appears to act as a partial agonist of dopamine type 2 (D2) and 3 (D3) receptors.
• The D2 and D3 receptors have been identified as targets for therapy of schizophrenia where they appear to be overstimulated.
• Cariprazine also may have some degree of activity against selected serotonin receptors (5-HT1A).
• In short term clinical trials, cariprazine was shown to improve symptoms in patients with schizophrenia and manic or mixed episodes of bipolar I disorder.

Who Should Not Use this medicine ?

This medicine caanot be used in patients with:

• a history of a hypersensitivity reaction to cariprazine.

What drug interactions can this medicine cause?

• If Vraylar is used with a strong CYP3A4 inhibitor, reduce Vraylar dosage (eg: itraconazole, ketoconazole)
• Concomitant use of Vraylar with a CYP3A4 inducer is not recommended (eg: rifampin, carbamazepine)

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Because of the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks.

Recommended Dosage: Schizophrenia

• The recommended dosage range is 1.5 mg to 6 mg once daily.
• The starting dosage of Vraylar is 1.5 mg daily.
• The dosage can be increased to 3 mg on Day 2.
• Depending upon clinical response and tolerability, further dose adjustments can be made in 1.5 mg or 3 mg increments.
• The maximum recommended dosage is 6 mg daily.
• In short-term controlled trials, dosages above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

Manic or Mixed Episodes Associated with Bipolar I Disorder

• The recommended dosage range is 3 mg to 6 mg once daily. The starting dose of Vraylar is 1.5 mg and should be increased to 3 mg on Day 2.
• Depending upon clinical response and tolerability, further dose adjustments can be made in 1.5 mg or 3 mg increments.
• The maximum recommended dosage is 6 mg daily.
• In short-term controlled trials, dosages above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

Depressive Episodes Associated with Bipolar I Disorder (Bipolar Depression)

• The starting dose of Vraylar is 1.5 mg once daily.
• Depending upon clinical response and tolerability, the dosage can be increased to 3 mg once daily on Day 15.
• Maximum recommended dosage is 3 mg once daily.

Administration

• Vraylar is given orally once daily and can be taken with or without food.
• Take Vraylar exactly as your healthcare provider tells you to take it.
• Do not change the dose or stop taking Vraylar without first talking to your healthcare provider.
• Vraylar can be taken with or without food.
• If you take too much Vraylar, call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room, right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 1.5 mg, 3 mg, 4.5 mg, and 6 mg

This medicine is available in fallowing brand namesː

• Vraylar

What side effects can this medication cause?

The most common side effects of this medicine include:

• difficulty moving or slow movements
• tremors
• uncontrolled body movements
• restlessness and feeling like you need to move around
• sleepiness
• nausea
• vomiting
• indigestion

Vraylar may cause serious side effects, including:

• Increased risk of death in elderly people with dementia related psychosis
• Increased risk of suicidal thoughts or actions in children and young adults
• Uncontrolled body movements (tardive dyskinesia)
• Late occurring side effects
• Problems with your metabolism

What special precautions should I follow?

• Antipsychotic drugs increase the all-cause risk of death in elderly patients with dementia-related psychosis. Vraylar is not approved for the treatment of patients with dementia-related psychosis.
• Do not drive, operate machinery, or do other dangerous activities until you know how Vraylar affects you. Vraylar may make you drowsy.
• Do not become too hot or dehydrated during treatment with Vraylar.
• Do not exercise too much.
• In hot weather, stay inside in a cool place if possible.
• Stay out of the sun.
• Do not wear too much clothing or heavy clothing.
• Drink plenty of water.
• Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, has been reported in association with administration of antipsychotic drugs. If NMS is suspected, immediately discontinue Vraylar and provide intensive symptomatic treatment and monitoring.
• Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs, including Vraylar. If signs and symptoms of tardive dyskinesia appear in a patient on Vraylar, drug discontinuation should be considered. However, some patients may require treatment with Vraylar despite the presence of the syndrome.
• Adverse events may first appear several weeks after the initiation of Vraylar treatment, probably because plasma levels of cariprazine and its major metabolites accumulate over time. Monitor for adverse reactions, including extrapyramidal symptoms (EPS) or akathisia, and patient response for several weeks after a patient has begun Vraylar and after each dosage increase.
• Atypical antipsychotic drugs, including Vraylar, have caused metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain.
• Leukopenia and neutropenia have been reported during treatment with antipsychotic agents, including Vraylar. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue Vraylar in patients with absolute neutrophil count < 1000/mm3 and follow their WBC until recovery.
• Atypical antipsychotics cause orthostatic hypotension and syncope. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope.
• Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• orthostasis and sedation

Management of Overdosage

• No specific antidotes for Vraylar are known.
• In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. In case of an overdose, consult a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice.

Can this medicine be used in pregnancy?

• There are no available data on Vraylar use in pregnant women to inform any drug-associated risks for birth defects or miscarriage.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Vraylar during pregnancy.
• For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: cariprazine hydrochloride
• Inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide.
• Colorants include: black iron oxide, FD&C Blue I, FD&C Red 3, FD&C Red 40, or yellow iron oxide.

Who manufactures and distributes this medicine?

• Manufactured by: Forest Laboratories Ireland Limited, Dublin, IE. Distributed by: Allergan USA, Inc. Madison

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

• Store Vraylar at room temperature, between 68°F to 77°F (20°C to 25°C).
• Keep Vraylar and all medicines out of the reach of children.

• Dailymed label info on Cariprazine
• FDA Cariprazine

Cariprazine Resources
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Cariprazine Resources
Latest articles Most recent articles Ongoing trials	Wikipedia