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Vraylar

CARIPRAZINE

Manufacturer: Allergan, Inc.

Score: 144.0

Quick Summary

Vraylar (Cariprazine) is an atypical antipsychotic used for the treatment of schizophrenia, acute treatment of manic or mixed episodes associated with bipolar I disorder, treatment of depressive episodes associated with bipolar I disorder, and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder. The recommended dosage ranges from 1.5 mg to 6 mg once daily, depending on the condition being treated. Important safety information includes increased mortality in elderly patients with dementia-related psychosis, suicidal thoughts and behaviors in pediatric and young adult patients, and potential for extrapyramidal symptoms and akathisia. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of schizophrenia in adults
  • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults
  • Treatment of depressive episodes associated with bipolar I disorder in adults
  • Adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors in pediatric and young adult patients

Contraindications

  • History of a hypersensitivity reaction to cariprazine

Adverse Reactions

  • Extrapyramidal symptoms
  • Akathisia
  • Dyspepsia
  • Vomiting
  • Somnolence
  • Restlessness
  • Nausea
  • Increased appetite
  • Dizziness
  • Insomnia

Dosing Recommendations

General Guidance

Dosage modifications for CYP3A4 inhibitors and inducers, and for patients with hepatic or renal impairment

Schizophrenia

Adult Dose

1.5 mg to 6 mg once daily

Pediatric Dose

Not established

Bipolar Mania

Adult Dose

3 mg to 6 mg once daily

Pediatric Dose

Not established

Bipolar Depression

Adult Dose

1.5 mg or 3 mg once daily

Pediatric Dose

Not established

Major Depressive Disorder (adjunctive therapy)

Adult Dose

1.5 mg or 3 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Vraylar during pregnancy
  • Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery

Nursing Mothers

  • No information available

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established
  • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients

Geriatric Use

  • Clinical trials of Vraylar did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients
  • Antipsychotic drugs increase the risk of death in elderly patients with dementia-related psychosis

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