How to dose VRAYLAR for bipolar I disorder in depressive and acute manic or mixed episodes1

One capsule1

Once daily1

With or without food1

  • *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

Effective VRAYLAR doses for bipolar I1

BIPOLAR I DEPRESSION1

Recommended dose: 1.5 or 3 mg/day

  • Day 1—Start patient at 1.5 mg
  • Day 15—May increase dose to 3 mg

Maximum recommended dose is 3 mg/day, depending on clinical response and tolerability.

BIPOLAR I MANIA OR MIXED1

Recommended dose: 3–6 mg/day

  • Day 1—Start patient at 1.5 mg
  • Day 2—Increase dose to 3 mg

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

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

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 in cariprazine1

Clinically significant drug interactions and dosage adjustments with VRAYLAR1

Clinical impact

Strong CYP3A4 inhibitors

CYP3A4 inducers

Intervention

Initiating strong CYP3A4 inhibitor while on a stable dose of VRAYLAR Reduce the current dosage of VRAYLAR by half:

  • For 4.5 mg/day, the dosage should be reduced to 1.5 mg/day or 3 mg/day
  • For 1.5 mg/day, adjust regimen to every other day

Initiating VRAYLAR therapy while already on a strong CYP3A4 inhibitor

  • 1.5 mg of VRAYLAR on Day 1 and Day 3 with no dose on Day 2
  • From Day 4 onward, 1.5 mg/day of VRAYLAR then increase to a maximum dose of 3 mg/day

When the CYP3A4 inhibitor is withdrawn, VRAYLAR dosage may need to be increased

Not recommended

Clinical impact

Strong CYP3A4 inhibitors

Intervention

Initiating strong CYP3A4 inhibitor while on a stable dose of VRAYLAR Reduce the current dosage of VRAYLAR by half:

  • For 4.5 mg/day, the dosage should be reduced to 1.5 mg/day or 3 mg/day
  • For 1.5 mg/day, adjust regimen to every other day

Initiating VRAYLAR therapy while already on a strong CYP3A4 inhibitor

  • 1.5 mg of VRAYLAR on Day 1 and Day 3 with no dose on Day 2
  • From Day 4 onward, 1.5 mg/day of VRAYLAR then increase to a maximum dose of 3 mg/day

When the CYP3A4 inhibitor is withdrawn, VRAYLAR dosage may need to be increased

Clinical impact

CYP3A4 inducers

Intervention

Not recommended