For bipolar I and II depression in adultsWell-established safety and tolerability profile1
There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in patients treated with CAPLYTA1
| Most common adverse reactions in 6-week pivotal trials1* | ||||
|---|---|---|---|---|
| POOLED Monotherapy | Adjunctive (with lithium or valproate) | |||
| ADVERSE REACTION (PROPORTION OF PATIENTS) | CAPLYTA (n=372) | Placebo (n=374) | CAPLYTA (n=177) | Placebo (n=175) |
| Somnolence/sedation | 13% | 3% | 13% | 3% |
| Dizziness† | 8% | 4% | 11% | 2% |
| Nausea | 8% | 3% | 9% | 4% |
| Dry mouth | 5% | 1% | 5% | 1% |
Swipe table for more
| Most common adverse reactions in 6-week pivotal trials1* | ||||
|---|---|---|---|---|
| POOLED Monotherapy | Adjunctive (with lithium or valproate) | |||
| ADVERSE REACTION (PROPORTION OF PATIENTS) | CAPLYTA (n=372) | Placebo (n=374) | CAPLYTA (n=177) | Placebo (n=175) |
| Somnolence/sedation | 13% | 3% | 13% | 3% |
| Dizziness† | 8% | 4% | 11% | 2% |
| Nausea | 8% | 3% | 9% | 4% |
| Dry mouth | 5% | 1% | 5% | 1% |
In 6-week pivotal trials, 99% of participants receiving CAPLYTA did not experience clinically significant weight gain,‡ and metabolic parameters, including prolactin levels, were similar to placebo2-4
View data
In 6-week pivotal trials, incidence of EPS,§ including akathisia, were similar to placebo (monotherapy: 1.3% CAPLYTA and 1.1% placebo; adjunctive therapy with lithium/valproate: 4.0% CAPLYTA and 2.3% placebo), and sexual side effects were not common4
View dataIn a 6-month, open-label, monotherapy safety extension trial, the most common adverse reactions were headache, dry mouth, dizziness, and nausea.5‖
‖Limitation: This open-label safety extension trial was designed primarily to assess long-term safety and tolerability.5
*≥5% of patients exposed to CAPLYTA and greater than twice the rate of placebo.1
†Dizziness, dizziness postural.1
‡Defined as ≥7% increase from baseline to 6 weeks.2,3
§EPS include akathisia, extrapyramidal disorder, muscle spasms, muscle twitching, musculoskeletal stiffness, restlessness, dyskinesia, tremor, movement disorder, and gait disturbance.4
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.
