Safety

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Safety profile

In clinical trials, INGREZZA® (valbenazine) capsules was generally well tolerated across a broad range of adult tardive dyskinesia patients1,2

INGREZZA safety profile1

Combined safety across 3 key studies1

Adverse reactions in 3 placebo-controlled studies of a 6-week treatment duration reported at ≥2% and >placebo (safety population)1

Adverse Reaction INGREZZA (n=262) (%) Placebo (n=183) (%)
Somnolence 10.9% 4.2%
Anticholinergic effects 5.4% 4.9%
Balance disorders/fall 4.1% 2.2%
Headache 3.4% 2.7%
Akathisia 2.7% 0.5%
Vomiting 2.6% 0.6%
Nausea 2.3% 2.1%
Arthralgia 2.3% 0.5%
  • Discontinuation due to adverse reactions was 3% with INGREZZA vs 2% with placebo1

Patients in the clinical trials were allowed to remain on their stable psychiatric treatment regimen1,2

  • 85% took second-generation antipsychotics

  • 27% took first-generation antipsychotics

Adverse reactions by dose

Adverse reactions by dose in KINECT 32

Treatment-emergent adverse reactions with incidence ≥2% in all patients treated with INGREZZA® (valbenazine) capsules and at a higher incidence than placebo during the 6-week treatment period (safety population)

Adverse Reaction ALL INGREZZA treated (n=151) (%) INGREZZA 40 mg (n=72) (%) INGREZZA 80 mg (n=79) (%) Placebo (n=76) (%)
Overall 45.7% 40.3% 50.6% 43.4%
Somnolence 5.3% 5.6% 5.1% 3.9%
Akathisia 3.3% 4.2% 2.5% 1.3%
Dry mouth 3.3% 6.9% 0.0% 1.3%
Arthralgia 2.6% 1.4% 3.8% 1.3%
Dyskinesia 2.0% 0.0% 3.8% 0.0%
Vomiting 2.0% 0.0% 3.8% 0.0%
Anxiety 2.0% 1.4% 2.5% 0.0%
Fatigue 2.0% 2.8% 1.3% 1.3%
Weight increase 2.0% 1.4% 2.5% 0.0%
Insomnia 2.0% 1.4% 2.5% 1.3%

The most common types of concomitant medications were2,3:

  • Antipsychotics (85.5%)

  • Antidepressants (66.5%)

  • Anticholinergics (37.0%)

  • Antiepileptics (35.2%)

  • Anxiolytics (27.7%)

  • ACE inhibitors (25.6%)

Safety assessment scales

Mean psychiatric scale scores generally remained stable across the study period3

In the clinical study, patients were monitored for the effects of INGREZZA® (valbenazine) capsules on their existing psychiatric disorders2

Safety assessments of psychiatric disorders from baseline through 6 weeks3

Disorder Mean score increased or worsened Measure
Schizophrenia No PANSSa
Mania No YMRSb
Suicidal ideation/behavior No C-SSRSc
Depression No CDSS,d MADRSe

Drug-induced parkinsonism generally remained stablea across the study period3

In one 6-week, phase 3, placebo-controlled study, the mean change from baseline on the Simpson-Angus Scale at 6 weeks was2,3:

  • −0.03 for INGREZZA 40 mg
  • −0.04 for INGREZZA 80 mg
  • −0.11 for placebo
a There were no clinically significant changes in mean Simpson-Angus Scale scores during the study.
  • aMean change in Positive and Negative Syndrome Scale (PANSS) total score from baseline at 6 weeks was −0.4 for INGREZZA 40 mg, −0.8 for INGREZZA 80 mg, and ±0.0 for placebo.
  • bMean change in Young Mania Rating Scale (YMRS) total score from baseline at 6 weeks was −0.4 for INGREZZA 40 mg, −1.4 for INGREZZA 80 mg, and +0.5 for placebo.
  • cIncidence of suicidal ideation or behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) was 5.6% for INGREZZA 40 mg, 2.5% for INGREZZA 80 mg, and 5.3% for placebo.
  • dMean change in Calgary Depression Scale for Schizophrenia (CDSS) total score from baseline at 6 weeks was −0.5 for INGREZZA 40 mg, −0.4 for INGREZZA 80 mg, and −0.1 for placebo.
  • eMean change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline at 6 weeks was ±0.0 for INGREZZA 40 mg, −1.5 for INGREZZA 80 mg, and +1.2 for placebo.