What is the starting dose of Vraylar (cariprazine)?

Starting Dose of Vraylar (Cariprazine)

The starting dose of Vraylar (cariprazine) is 1.5 mg orally once daily. 1

Dosing Recommendations by Indication

Schizophrenia

• Starting dose: 1.5 mg once daily 1
• Can be increased to 3 mg on Day 2 1
• Recommended dose range: 1.5-6 mg once daily 1
• Further dose adjustments can be made in 1.5 mg or 3 mg increments based on clinical response and tolerability 1
• Maximum recommended dose: 6 mg once daily 1

Bipolar I Disorder (Manic or Mixed Episodes)

• Starting dose: 1.5 mg once daily 1
• Increase to 3 mg once daily on Day 2 1
• Recommended dose range: 3-6 mg once daily 1
• Maximum recommended dose: 6 mg once daily 1

Bipolar Depression

• Starting dose: 1.5 mg once daily 1
• Can be increased to 3 mg once daily on Day 15 1
• Maximum recommended dose: 3 mg once daily 1

Major Depressive Disorder (Adjunctive Therapy)

• Starting dose: 1.5 mg once daily 1
• Can be increased to 3 mg once daily on Day 15 1
• Maximum recommended dose: 3 mg once daily 1

Important Clinical Considerations

Pharmacokinetics

• Cariprazine has a long half-life and active metabolites 1, 2
• Changes in dose will not be fully reflected in plasma for several weeks 1
• Steady state is reached within 1-2 weeks for cariprazine and desmethyl-cariprazine, but takes approximately 4 weeks for didesmethyl-cariprazine 3
• The effective half-life of total active moieties is approximately 1 week 3

Monitoring

• Monitor patients for adverse reactions and treatment response for several weeks after starting cariprazine and after each dosage change 1
• The most common adverse events include extrapyramidal symptoms (NNH 15 for 1.5-3 mg/day) and akathisia (NNH 20 for 1.5-3 mg/day) 2

Dosage Modifications with CYP3A4 Inhibitors

• When initiating cariprazine in patients taking a strong CYP3A4 inhibitor:
  • For schizophrenia: Start at 1.5 mg every 3 days; can increase to 1.5 mg every other day if needed 1
  • For bipolar disorders and MDD: 1.5 mg every 3 days 1
• When initiating cariprazine in patients taking a moderate CYP3A4 inhibitor:
  • For schizophrenia: Start at 1.5 mg every other day; can increase to 1.5 mg daily if needed 1
  • For bipolar disorders and MDD: 1.5 mg every other day 1

Special Populations

• No specific dose adjustments are recommended for elderly patients, but caution is advised as elderly patients with dementia-related psychosis have increased mortality risk 1
• Cariprazine is not approved for pediatric patients 1, although pharmacokinetic parameters in pediatric studies appear consistent with those observed in adults 4

Clinical Pearls

• Cariprazine is a dopamine D3-preferring D3/D2 receptor partial agonist, distinguishing it from other antipsychotics 2, 5
• Unlike some other antipsychotics, cariprazine does not appear to cause significant weight gain, metabolic abnormalities, prolactin increase, or QT prolongation 2, 5
• Cariprazine can be taken with or without food 1
• Concomitant use with CYP3A4 inducers is not recommended 1