CAPLYTA demonstrated safety in 1,724 adult patients with schizophrenia1
For schizophrenia in adults
Most common adverse reactions in 4‑ to 6‑week trials1,2*
Proportion of patients (%) experiencing somnolence/sedation or dry mouth1,2
Proportion of patients (%) | CAPLYTA (n=406) | Placebo (n=412) |
|---|---|---|
Somnolence/Sedation | 24% | 10% |
Dry mouth | 6% | 2% |
Proportion of patients (%) | CAPLYTA (n=406) | Placebo (n=412) |
|---|---|---|
Somnolence/Sedation | 24% | 10% |
Dry mouth | 6% | 2% |
Somnolence with CAPLYTA was predominantly mild3
There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in patients treated with CAPLYTA2
*Incidence of at least 5% of subjects exposed to CAPLYTA and greater than twice the rate of placebo.2
In short-term trials, patients on CAPLYTA experienced metabolic, EPS,
prolactin, and weight changes similar to placebo2
EPS=extrapyramidal symptoms.
WARNINGS & PRECAUTIONS: Antipsychotic drugs have been reported to cause:
- Tardive Dyskinesia (TD) may develop in patients treated with antipsychotic drugs, including CAPLYTA. TD can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. The TD risk appears to be highest in elderly women. The likelihood that TD will become irreversible increases with the duration of the antipsychotic drug treatment and cumulative dose. If signs and symptoms of TD appear, consider discontinuing 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.
Please see additional Important Safety Information, including Boxed WARNINGS, below.
Frequently Asked Questions
CAPLYTA does not require routine monitoring for liver function.2 Among adverse reactions reported in 4- to 6-week schizophrenia trials with CAPLYTA, hepatic transaminases increased in 2% of patients receiving CAPLYTA 42 mg and in 1% of those receiving placebo.2
Alternative doses are available for patients with hepatic impairment.
Among schizophrenia patients who received CAPLYTA, 24% reported somnolence/sedation and and there was no single adverse reaction leading to discontinuation in CAPLYTA-treated patients. Among bipolar I & II depression patients who received CAPLYTA, 13% in both monotherapy and adjunctive trials reported somnolence/sedation and there was no single adverse reaction leading to discontinuation in CAPLYTA-treated patients.2
