Safety & Tolerability
Weight change on CAPLYTA was similar to placebo in short-term trials1
In short-term 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 of CAPLYTA, patients experienced1:
-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
Prolactin levels were similar to placebo3
Mean change in prolactin from baseline3
CAPLYTA had a favorable metabolic and endocrine profile with long-term use3
Mean change from baseline in metabolic and endocrine parameters in a long-term trial3
|Blood Glucose/Insulin||Day 300*|
|Glucose (mg/dL)||+3.0 (n=172)|
|Insulin (mcIU/mL)||+1.0 (n=168)|
|Total Cholesterol||-9.6 (n=172)|
|Prolactin||-4.9 (n = 171)|
Changes in weight in short- and long-term trials3
|Weight (lbs)||Short-term trials†||Day 175*||Day 350*|
|CAPLYTA 42 mg||+3.5 (n=388)||-4.2 (n=328)||-7.2 (n=107)|
Weight change on CAPLYTA was similar to placebo in short-term trials1
Data from 1-year open-label safety study. See study design below.
Data reported from 4- to 6-week placebo-controlled studies.3
- Antipsychotic drugs have been reported to cause weight gain. Measure weight when initiating CAPLYTA and monitor periodically during long-term treatment
Shifts from baseline in key metabolic parameters at Day 3003‡
|Shifted Normal to Low||Remained Normal||Shifted Normal to High|
|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
Long-term data is from an open-label study of 603 stable outpatients with schizophrenia who discontinued their current antipsychotic treatment and started CAPLYTA 42 mg with no dose titration. Assessment of safety, tolerability, and efficacy were conducted at baseline and were measured at Day 8, 15, 25, and approximately every 25 days thereafter, for up to 1 year.3
The primary objective was to evaluate the safety and tolerability of CAPLYTA.3
- 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
Important Safety Information
Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.
Warnings & Precautions: Antipsychotic drugs have been reported to cause:
- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
- Neuroleptic Malignant Syndrome, which is a potentially fatal reaction. Signs and symptoms include: hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation of CAPLYTA and provide intensive symptomatic treatment and monitoring.
- Tardive Dyskinesia, a syndrome of potentially irreversible, dyskinetic, and involuntary movements which may increase as the duration of treatment and total cumulative dose increases. The syndrome can develop after a relatively brief treatment period, even at low doses. It may also occur after discontinuation of treatment. Given these considerations, CAPLYTA should be prescribed in a manner most likely to reduce the risk of tardive dyskinesia. Discontinue CAPLYTA if clinically appropriate.
- Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
- Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Perform complete blood counts in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Discontinue CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors.
- Orthostatic Hypotension and Syncope. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
- Falls. CAPLYTA may cause somnolence, postural hypotension, and motor and/or sensory instability, which may lead to falls and, consequently, fractures and other injuries. Assess patients for risk when using CAPLYTA.
- Seizures. Use CAPLYTA cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
- Potential for Cognitive and Motor Impairment. Advise patients to use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
- Body Temperature Dysregulation. Use CAPLYTA with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
- Dysphagia. Use CAPLYTA with caution in patients at risk for aspiration.
Drug Interactions: Avoid concomitant use with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.
Special Populations: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Avoid use in patients with moderate or severe hepatic impairment.
Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).
CAPLYTA is indicated for the treatment of schizophrenia in adults.
Please see full Prescribing Information, including Boxed Warning.