Adverse Reactions
Adverse Reactions Discontinuations Metabolic Profile

REXULTI® (brexpiprazole) + antidepressants:
safety profile in adult patients with MDD

Adverse reactions that occurred in ≥2% of patients and with greater incidence than placebo from two 6-week pivotal trials across all doses

Rates for ADTa + REXULTI (all doses; n=643) vs ADTa + placebo (n=411)

  • Akathisia 9% vs 2%
  • Headache 7% vs 6%
  • Weight increase 7% vs 2%
  • Somnolence 5% vs 0.5%
  • Nasopharyngitis 4% vs 2%
  • Tremor 4% vs 2%
  • Fatigue 3% vs 2%
  • Increased appetite 3% vs 2%
  • Anxiety 3% vs 1%
  • Dizziness 3% vs 1%
  • Restlessness 3% vs 0%
  • Blood cortisol decrease 2% vs 1%
  • Constipation 2% vs 1%
  • Increased appetite 3% vs 2%
  • Anxiety 3% vs 1%
  • Dizziness 3% vs 1%
  • Restlessness 3% vs 0%
  • Blood cortisol decrease 2% vs 1%
  • Constipation 2% vs 1%

The most common adverse reactions (≥5%) and at least twice the rate of placebo for ADT + REXULTI vs ADT +  
placebo were weight increased (7% vs 2%), somnolence (5% vs 0.5%), and akathisia (9% vs 2%)

  • In patients taking ADT + REXULTI (n=643, all doses) vs ADT + placebo (n=411), the incidence of decreased libido   
    was 0.6% vs 0.2%, respectively1

The most common adverse reactions (≥5%) and at least twice the rate of placebo for ADT + REXULTI vs ADT + placebo were weight increased (7% vs 2%), somnolence (5% vs 0.5%), and akathisia (9% vs 2%)

  • In patients taking ADT + REXULTI (n=643, all doses) vs ADT + placebo (n=411), the incidence of decreased libido was 0.6% vs 0.2%, respectively1

Two adverse reactions were dose-dependent

Dose dependent Adverse Reactions vs placebo chart

Two adverse reactions were dose-dependent

Dose dependent Adverse Reactions vs placebo chart

aThe antidepressants studied included SSRIs and SNRIs. 
The safety population included patients randomized between 1 mg/day and 3 mg/day of ADT + REXULTI.

 

REXULTI + antidepressants: few discontinuations due to adverse reactions over 6 weeks across all doses

Discontinuation rates for antidepressant
treatment + REXULTI vs antidepressant treatment + placebo

discontinuation rates REXULTI vs placebo diagram Discontinuation Rates diagram ADT + REXULTI (n=643) 3 % ADT + Placebo (n=411) 1 %

Discontinuation rates for antidepressant treatment + REXULTI vs antidepressant treatment + placebo

discontinuation rates REXULTI vs placebo diagram Discontinuation Rates diagram ADT + Placebo (n=411) 1 % ADT + REXULTI (n=643) 3 %

In patients taking ADT + REXULTI (n=643, all doses) vs ADT + placebo (n=411), the rate of discontinuation due to akathisia was 0.9% vs 0% and the rate of discontinuation due to weight gain was 0% vs 0%, respectively3,4

Discontinuations due to most common adverse events

Dose dependent Adverse Reactions chart Dose dependent Adverse Reactions chart

Discontinuations due to most common adverse events

Dose dependent Adverse Reactions chart Dose dependent Adverse Reactions chart
View dosing information and titration schedule
 

REXULTI + antidepressants: metabolic profile in short- and long-term trials

METABOLIC CHANGE

Percentage of patients whose values shifted from baseline to post-baseline5,6

Percentage of patients whose values shifted from baseline to post-baseline5,6

Percentage of patients whose values shifted from baseline to post baseline. Percentage of patients whose values shifted from baseline to post baseline.
Percentage of patients whose values shifted from baseline to post baseline. Percentage of patients whose values shifted from baseline to post baseline.