Dosing

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One Capsule1

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Once Daily1

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With or Without Food1

VRAYLAR 1.5 mg capsule.

1.5 mg/day

Starting Dose

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Adjunctive Therapy to Antidepressants for MDD Recommended Doses

Adjunctive Therapy to Antidepressants for MDD and Bipolar I Depression Recommended Dose.
  • 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

Adjunctive Therapy to Antidepressants for MDD and Bipolar I Depression Recommended Dose.
  • 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

Bipolar I Acute Manic or Mixed Episode 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

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:

 

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Mild or moderate hepatic or renal impairment

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Smoking status

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Age

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Race

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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
  • For patients currently taking VRAYLAR 1.5 or 3 mg once daily, adjust VRAYLAR dosage to 1.5 mg every 3 days
  • For patients currently taking VRAYLAR 4.5 or 6 mg once daily, the VRAYLAR dosage should be reduced to 1.5 mg every other day
Initiating VRAYLAR therapy while already on a strong CYP3A4 inhibitor
  • Bipolar I depression and as adjunctive therapy to antidepressants for MDD: VRAYLAR starting dose is 1.5 mg every 3 days
  • Bipolar I acute manic or mixed episodes and schizophrenia: start VRAYLAR at 1.5 mg every 3 days; increase to 1.5 mg every other day, if needed†
When a strong or moderate CYP3A4 inhibitor is withdrawn, VRAYLAR dosage may need to be increased†
Moderate CYP3A4 inhibitors Initiating moderate CYP3A4 inhibitor while on a stable dose of VRAYLAR
  • For patients currently taking VRAYLAR 1.5 or 3 mg once daily, adjust VRAYLAR dosage to 1.5 mg every other day
  • For patients currently taking VRAYLAR 4.5 or 6 mg once daily, the VRAYLAR dosage should be reduced to 1.5 mg once daily
Initiating VRAYLAR while already on a moderate CYP3A4 inhibitor
  • Bipolar I depression and as adjunctive therapy to antidepressants for MDD: VRAYLAR starting dose is 1.5 mg every other day
  • Bipolar I acute manic or mixed episodes and schizophrenia: start VRAYLAR at 1.5 mg every other day; increase to 1.5 mg daily, if needed†
When a strong or moderate CYP3A4 inhibitor is withdrawn, VRAYLAR dosage may need to be increased†
CYP3A4 inducers Concomitant use of VRAYLAR with a CYP3A4 inducer has not been evaluated and is not recommended

 

 

†Depending upon clinical response and tolerability.

Pharmacokinetics