Vraylar (Cariprazine) Dosing for Schizophrenia and Bipolar Disorder
For patients with schizophrenia or bipolar disorder, Vraylar (cariprazine) should be started at 1.5 mg once daily, with titration to 1.5-6 mg daily for schizophrenia, 3-6 mg daily for bipolar mania, and 1.5-3 mg daily for bipolar depression, based on clinical response and tolerability.
Dosing Guidelines by Indication
Schizophrenia
- Starting dose: 1.5 mg orally once daily
- Day 2: May increase to 3 mg once daily
- Subsequent adjustments: Can be made in 1.5 mg or 3 mg increments based on response and tolerability
- Recommended range: 1.5-6 mg once daily
- Maximum dose: 6 mg once daily (higher doses do not provide additional benefit but increase side effects) 1
Bipolar I Disorder - Manic or Mixed Episodes
- Starting dose: 1.5 mg orally once daily
- Day 2: Increase to 3 mg once daily
- Subsequent adjustments: Can be made in 1.5 mg or 3 mg increments based on response and tolerability
- Recommended range: 3-6 mg once daily
- Maximum dose: 6 mg once daily 1
Bipolar I Disorder - Depressive Episodes
- Starting dose: 1.5 mg orally once daily
- Day 15: May increase to 3 mg once daily based on response and tolerability
- Maximum dose: 3 mg once daily 1
Administration Considerations
- Vraylar can be taken with or without food 1
- Due to the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks
- Patients should be monitored for adverse reactions and treatment response for several weeks after starting Vraylar and after each dosage change 1
Special Populations and Considerations
Patients Taking CYP3A4 Inhibitors
When initiating Vraylar in patients already taking CYP3A4 inhibitors:
Strong CYP3A4 inhibitors:
- Schizophrenia: Start at 1.5 mg every 3 days; may increase to 1.5 mg every other day if needed
- Bipolar disorders: 1.5 mg every 3 days 1
Moderate CYP3A4 inhibitors:
- Schizophrenia: Start at 1.5 mg every other day; may increase to 1.5 mg daily if needed
- Bipolar disorders: 1.5 mg every other day 1
Pediatric Patients
While not FDA approved for pediatric use, research suggests:
- For adolescents (13-17 years), lower starting doses of 1.5 mg daily with slower titration may be appropriate 2
- Pharmacokinetic parameters in pediatric patients appear consistent with those observed in adults 2
Monitoring and Adverse Effects
- Common side effects: Akathisia, extrapyramidal symptoms, insomnia, and sedation 3
- Unlike some other antipsychotics, cariprazine is not typically associated with significant weight gain or metabolic abnormalities 3
- When used as adjunctive therapy for major depressive disorder, the 1.5 mg dose has shown better efficacy than the 3 mg dose 4
Clinical Pearls
- Cariprazine is a dopamine D3-preferring D3/D2 receptor partial agonist, distinguishing it from other antipsychotics 3
- Due to its very long half-life (2-5 days for cariprazine and 2-3 weeks for its active metabolite didesmethyl-cariprazine), steady state may not be reached for several weeks 5
- When switching from another antipsychotic to cariprazine, a gradual cross-titration approach is recommended 6
- For patients with negative symptoms of schizophrenia, cariprazine may be particularly beneficial 6
Caution
- Do not exceed recommended maximum doses (6 mg for schizophrenia and bipolar mania; 3 mg for bipolar depression) as higher doses increase risk of adverse effects without providing additional benefit 1
- Monitor patients closely during the first few weeks of treatment due to the long half-life of the medication and its metabolites 1