Fasting glucose in 3-week studies*†

VRAYLAR similar to placebo for the percentage of patients with shifts in fasting glucose1,5

*Data shown from baseline to endpoint (Day 21) by modal daily dose, defined as most frequently administered dose per patient.1,5

Recommended dose range of VRAYLAR is 3-6 mg/day. Doses above 6 mg did not appear to have additional benefit over lower doses and a dose-related increase in certain adverse reactions was observed.1

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. Assess fasting glucose before or soon after initiation of treatment, and monitor periodically during long-term treatment.


Total cholesterol and fasting triglycerides in 3-week studies*†

VRAYLAR similar to placebo for the percentage of patients with shifts in total cholesterol or fasting triglycerides1,5

*Data shown from baseline to endpoint (Day 21) by modal daily dose, defined as most frequently administered dose per patient.1,5

Recommended dose range of VRAYLAR is 3-6 mg/day. Doses above 6 mg did not appear to have additional benefit over lower doses and a dose-related increase in certain adverse reactions was observed.1

Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after starting an antipsychotic, obtain baseline fasting lipid profile and monitor periodically during treatment.


Body weight in 3-week studies*†

VRAYLAR (3-6mg/day) similar to placebo for the percentage of patients with ≥7% increase in weight1
Mean change from baseline to endpoint1
  Placebo
(n = 439)
VRAYLAR
3–6 mg/day
(n = 259)
Weight
(kg)
+0.2 +0.5

*Data shown from baseline to endpoint (Day 21) by modal daily dose, defined as most frequently administered dose per patient.1,5

Recommended dose range of VRAYLAR is 3-6 mg/day. Doses above 6 mg did not appear to have additional benefit over lower doses and a dose-related increase in certain adverse reactions was observed.1

Weight Gain: Weight gain has been observed with VRAYLAR. Monitor weight at baseline and frequently thereafter.

Prolactin in 3-week studies*†

No clinically relevant changes in prolactin levels were observed in short-term studies5

*Data shown from baseline to endpoint (Day 21) by modal daily dose, defined as most frequently administered dose per patient.1,5

Recommended dose range of VRAYLAR is 3-6 mg/day. Doses above 6 mg did not appear to have additional benefit over lower doses and a dose-related increase in certain adverse reactions was observed.1

Most common adverse reactions in 3-week studies

Adverse reactions (≥ 5% and at least twice that of placebo)1

  Placebo
(n = 442)
Recommended dose range
VRAYLAR
3-6 mg/day*
(n = 263)
VRAYLAR
9-12 mg/day*
(n = 360)
Extrapyramidal symptoms (EPS) 12% 26% 29%
Akathisia 5% 20% 21%
Vomiting 4% 10% 8%
Dyspepsia 4% 7% 9%
Somnolence 4% 7% 8%
Restlessness 2% 7% 7%
> 92% of patients with EPS and akathisia experienced symptoms of mild or moderate severity5

*Data shown by modal daily dose, defined as most frequently administered dose per patient.1

EPS include bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, hypokinesia, muscle rigidity, muscle tightness, musculoskeletal stiffness, oromandibular dystonia, parkinsonism, salivary hypersecretion, and tremor.1

Somnolence includes hypersomnia, sedation, and somnolence.1

Discontinuation rates due to adverse reactions1

  • There was an overall 12% discontinuation rate due to adverse reactions for VRAYLAR-treated patients vs 7% for placebo
  • The only adverse reaction leading to discontinuation in VRAYLAR-treated patients that occurred at a rate of ≥ 2% and at least twice the rate of placebo was akathisia (2%)
EPS

1%

discontinuation rate (excluding akathisia and restlessness) in VRAYLAR-treated patients vs 0.2% for placebo1

Akathisia

2%

discontinuation rate in VRAYLAR-treated patients vs 0% for placebo1

Somnolence

0%

discontinuation rate (somnolence included hypersomnia, sedation, and somnolence) in VRAYLAR- and placebo–treated patients5

  • Time to resolution of EPS and akathisia adverse reactions after treatment discontinuation was similar between VRAYLAR- and placebo-treated patients5
    • Median time to resolution of EPS and akathisia adverse reactions was ~6 days for VRAYLAR and ~7-8 days for placebo
  • Because of VRAYLAR's long half-life, adverse reactions may appear several weeks after initiation of VRAYLAR. Monitor for adverse reactions and patient response for several weeks after starting VRAYLAR and after each dosage change1