Bipolar I Depression Tolerability & Safety

Metabolics, prolactin, and weight change (bipolar I depression studies)

Shifts from baseline to endpoint1,2*

Fasting glucose Proportion of patients with metabolic shifts was similar to placebo
Total cholesterol
Fasting triglycerides
Prolactin (ng/mL) No meaningful
increase in mean levels

Weight change from baseline to endpoint in pivotal studies (6- and 8-week studies)1

at endpoint
Proportion of patients with
weight increase ≥7%
Placebo (n=463) -0.2 lb 1%
VRAYLAR 1.5 mg/day (n=467) +1.5 lb 3%
VRAYLAR 3 mg/day (n=465) +0.9 lb 3%

*Metabolic shift defined as: fasting glucose: normal (<100 mg/dL) to high (≥126 mg/dL), borderline (≥100 mg/dL and <126 mg/dL) to high; total cholesterol: normal/borderline (<240 mg/dL) to high (≥240 mg/dL); fasting triglycerides: normal/borderline (<200 mg/dL) to high (≥200 mg/dL)1,2

Recommended dose range of VRAYLAR is 1.5–3 mg/day for depressive episodes.1

Observed adverse reactions and discontinuation (bipolar I depression)

Most common adverse reactions (≥5% and at least twice that of placebo)1

    Recommended dose range
1.5 mg/day (n=470)
3 mg/day (n=469)
Nausea 3% 7% 7%
Akathisia 2% 6% 10%
Restlessness 3% 2% 7%
EPS 2% 4% 6%

Rates of somnolence and sedation in VRAYLAR 1.5 mg/day (7%) and 3 mg/day (6%) groups were similar to placebo (4%)1

>99% of EPS and akathisia events in bipolar I depression studies were mild or moderate17

EPS included akinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, hypokinesia, muscle tightness, musculoskeletal stiffness, myoclonus, oculogyric crisis, salivary hypersecretion, tardive dyskinesia, and tremor.1

EPS=extrapyramidal symptoms.

Discontinuation rates1

Overall, 6% of the patients who received VRAYLAR discontinued treatment due to an adverse reaction, compared with 5% of placebo-treated patients in these trials.

  Placebo VRAYLAR
1.5-3 mg/day
EPS (excluding akathisia/restlessness) 0% 0.4%
Akathisia 0% 1.5%

Monitor patients when initiating or changing the dose of VRAYLAR.1

EPS and akathisia are among the most common adverse reactions and are most frequently observed following initiation or up-titration.1,17

Most common sexual adverse reactions across clinical studies2

VRAYLAR 1.5 mg/day (n=470) VRAYLAR 3 mg/day (n=469)
Abnormal orgasm 0% 0% 0.4%
Decreased libido 0% 0.2% 0%
Erectile dysfunction  0% 0.6% 0.9%
Delayed ejaculation 0% 0% 0%