Safety & Tolerability

Weight change on CAPLYTA was similar to placebo in short-term trials1

In 4- to 6-week clinical trials, mean change in body weight from baseline at Day 28 was +3.5 lbs for CAPLYTA 42 mg and +2.9 lbs for placebo3

In a long-term study with CAPLYTA, patients saw1:

-4 lbs (average weight loss) after 6 months
-7 lbs (average weight loss) after 1 year

CAPLYTA had metabolic effects similar to placebo1

Mean change from baseline3

  • CAPLYTA mean change from baseline was similar to placebo in terms of glycemic control, total cholesterol, and triglycerides1
  • Data were collected in patients with acute schizophrenia over 4-6 weeks1,3

Changes in prolactin levels were similar to placebo3

Mean change in prolactin from baseline at 4 weeks3

Favorable weight, metabolic, and prolactin profile was observed in a 1-year trial with CAPLYTA3

Mean change from baseline in metabolic and endocrine parameters in a long-term open-label trial3

Blood Glucose/InsulinDay 300*
Glucose (mg/dL)+3.0 (n=172)
Insulin (mcIU/mL)+1.0 (n=168)
Lipids (mg/dL)
LDL-7.6 (n=167)
HDL-1.4 (n=172)
Total cholesterol-9.6 (n=172)
Triglycerides-2.5 (n=172)
Prolactin (ng/mL)
Prolactin-4.9 (n = 171)

Changes in weight3

Weight (lbs)Day 175*Day 350*
CAPLYTA 42 mg-4.2 (n=328)-7.2 (n=107)

Data from 1-year open-label safety study. See study design below.

≥80% of patients on CAPLYTA remained normal in Key Metabolic Parameters at Day 3003‡

Baseline Normal
Shifted Normal to LowRemained NormalShifted Normal to High
Blood glucose
Glucose (n=172)<1% (1/151)91% (138/151)8% (12/151)
Insulin (n=168)5% (7/134)83% (111/134)12% (16/134)
LDL cholesterol (n=167)3% (4/149)93% (139/149)4% (6/149)
Total cholesterol (n=172)12% (14/120)80% (96/120)8% (10/120)
Triglycerides (n=172)4% (6/155)92% (142/155)4.5% (7/155)

n=number of subjects with data. Baseline is defined as the last non-missing pretreatment measurement.3

    Important Safety Information regarding metabolic effects:

  • Metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain, have been reported with antipsychotic drugs1
  • Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. There have been reports of hyperglycemia in patients treated with CAPLYTA1
  • Assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment1