Dosing
One Capsule1
Once Daily1
With or Without Food1
1.5 mg/day
Starting Dose
Capsule images are not actual size
Adjunctive Therapy to Antidepressants for MDD Recommended Doses
- Day 1-Start at 1.5 mg/day
- Day 15–May increase dose to 3 mg/day
Maximum recommended dose is 3 mg/day, depending on clinical response and tolerability.
In clinical trials, dosage titration at intervals of less than 14 days resulted in a higher incidence of adverse reactions.1,2 (See adverse reactions from 8-week study in Section 6.1 of the full Prescribing Information).
Following discontinuation of VRAYLAR, the decline in plasma concentrations of active drug and metabolites may not be immediately reflected in patients’ clinical symptoms.1
Bipolar I Depression Recommended Doses
- Day 1–Start at 1.5 mg/day
- Day 15–May increase dose to 3 mg/day
Maximum recommended dose is 3 mg/day, depending on clinical response and tolerability.
Starting dose is a therapeutic dose for bipolar I depression
Following discontinuation of VRAYLAR, the decline in plasma concentrations of active drug and metabolites may not be immediately reflected in patients’ clinical symptoms1
Bipolar I Acute Manic or Mixed Episodes Recommended Doses
- Day 1–Start at 1.5 mg/day
- Day 2–Increase dose to 3 mg/day
Further adjustments can be made in 1.5- or 3-mg/day increments, up to a maximum recommended dose of 6 mg/day, depending on clinical response and tolerability.*
*In short-term controlled studies, doses above 6 mg/day did not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.1
Following discontinuation of VRAYLAR, the decline in plasma concentrations of active drug and metabolites may not be immediately reflected in patients’ clinical symptoms1
Schizophrenia Recommended Doses
Dose can be increased to 3 mg on Day 21
Further adjustments can be made in 1.5- or 3-mg increments, up to a maximum recommended dose of 6 mg/day, depending on clinical response and tolerability.*
*In short-term controlled studies, doses above 6 mg/day did not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.1
Following discontinuation of VRAYLAR, the decline in plasma concentrations of active drug and metabolites may not be immediately reflected in patients’ clinical symptoms1
Dosing adjustments
No dosage adjustment required based on1:
Mild or moderate hepatic or renal impairment
Smoking status
Age
Race
Sex
VRAYLAR is not recommended in patients with severe hepatic (Child-Pugh score 10–15) or renal impairment (creatinine clearance <30 mL/min), as it has not been evaluated in these patient populations1
VRAYLAR can be coadministered with a PPI. It does not affect VRAYLAR exposure at steady state1*
Monitoring fasting plasma glucose, fasting lipid profile, and CBCs is recommended for patients on antipsychotic treatment.1
*Pantoprazole 40 mg/day was coadministered with VRAYLAR 6 mg/day in patients with schizophrenia for 15 days.1
CBC=complete blood count; PPI=proton pump inhibitor.
Drug interactions
VRAYLAR is primarily metabolized by CYP3A4 and to a lesser extent by CYP2D6.1
CYP3A4 is responsible for the formation and elimination of the major active metabolites of cariprazine.1
Clinically significant drug interactions and dosage adjustments with VRAYLAR1
| Clinical impact | Intervention |
| Strong CYP3A4 inhibitors | Initiating strong CYP3A4 inhibitor while on a stable dose of VRAYLAR Reduce the current dosage of VRAYLAR by half:
Initiating VRAYLAR therapy while already on a strong CYP3A4 inhibitor
When the CYP3A4 inhibitor is withdrawn, VRAYLAR dosage may need to be increased |
| CYP3A4 inducers | Not recommended |