VRAYLAR bipolar I manic or mixed episodes safety

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

>92% of EPS and akathisia events in bipolar I manic studies were mild or moderate2

*Data shown from baseline to endpoint (Week 3) by modal daily dose, defined as most frequently administered dose per patient.1

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

Somnolence included hypersomnia, sedation, and somnolence.1

EPS=extrapyramidal symptoms.

Discontinuation rates1

Overall,12% of the patients who received VRAYLAR discontinued treatment due to an adverse reaction, compared with 7% of placebo-treated patients in these trials.

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

EPS and akathisia were among the most common adverse reactions and were most frequently observed upon initiation and up-titration.1,2