Safety

The most common* adverse reactions in 6-week bipolar depression trials were somnolence/sedation, dizziness, nausea, and dry mouth1

Proportion of patients (%) with:

MonotherapyCAPLYTA
(n=372)
Placebo
(n=374)
AdjunctiveCAPLYTA
(n=177)
Placebo
(n=175)
Somnolence/
sedation
13%3%13%3%
Dizziness8%4%11%2%
Nausea8%3%9%4%
Dry mouth5%1%5%1%
Proportion of
patients (%) with:
MonotherapyCAPLYTA
(n=372)
Placebo
(n=374)
Adjunctive Therapy with
Lithium or Valproate
CAPLYTA
(n=177)
Placebo
(n=175)
Somnolence/sedation13%3%13%3%
Dizziness8%4%11%2%
Nausea8%3%9%4%
Dry mouth5%1%5%1%

There was no single adverse reaction leading to discontinuation
that occurred at a rate of >2% in CAPLYTA-treated patients1

*Incidence of at least 5% of patients exposed to CAPLYTA and greater than twice the rate of placebo.1

Dizziness, dizziness postural.1

EPS profile was similar to placebo in monotherapy trials1*

Proportion of
patients (%)
MonotherapyCAPLYTAPlacebo
EPS*1.3%1.1%
Movement scores
BARS-0.1-0.1
AIMS0.00.0
SAS§0.00.0

Adjunctive trial with lithium or valproate EPS data1*

Proportion of
patients (%)
Adjunctive Therapy with Lithium or ValproateCAPLYTAPlacebo
EPS*4.0%2.3%
Movement scores
BARS0.0-0.1
AIMS0.00.0
SAS§0.00.0

*EPS (extrapyramidal symptoms) include akathisia, extrapyramidal disorder, muscle spasms, restlessness, dyskinesia, tremor, movement disorder, and gait disturbance.1

Barnes Akathisia Rating Scale (BARS) ranges from 0 to 14.

The Abnormal Involuntary Movement Scale (AIMS) for dyskinesia (total score ranges from 0 to 28).

§The Simpson-Angus Scale (SAS) for EPS (total score ranges from 0 to 40).

In data from short-term (6-week), placebo-controlled monotherapy and adjunctive therapy (with lithium or valproate) bipolar depression trials1:

Weight change was similar to placebo*

Weight gain has been observed with use of antipsychotics. Monitor weight at baseline and frequently thereafter.

Levels of fasting glucose, insulin, cholesterol and triglycerides were similar to placebo

Hyperglycemia has been reported in antipsychotic drugs, including CAPLYTA. Assess fasting plasma glucose when initiating CAPLYTA and monitor periodically during long-term treatment.

Antipsychotics have caused adverse alterations in lipids. Assess lipids when initiating CAPLYTA and monitor periodically during long-term treatment.

At 6 months in an uncontrolled open-label trial of CAPLYTA in patients with bipolar depression, the mean change in body weight was -0.02 lbs1

*Mean change from baseline and proportion of patients with an increase in weight ≥7% from baseline to end of study.1

Reference: 1. CAPLYTA prescribing information, 2021.