For bipolar I and II depression in adultsSexual side effects and EPS-related TEAEs
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| Safety data from 6-week pivotal trials and a 6-month, open-label safety trial1,2 | |||||
|---|---|---|---|---|---|
| pooled Monotherapy: 6 weeks | Adjunctive (with lithium or valproate): 6 weeks | OPEN-LABEL SAFETY TRIAL, MONOTHERAPY: 6 months* | |||
| SEXUAL DYSFUNCTION (PROPORTION OF PATIENTS) | CAPLYTA (N=372) | Placebo (N=374) | CAPLYTA (N=177) | Placebo (N=175) | CAPLYTA (N=127) |
| Erectile dysfunction† | 0.0% | 0.7% | 0.0% | 0.0% | |
| Libido decreased | 1.1% | 0.3% | 0.6% | 0.0% | |
| Orgasm abnormal | 0.3% | 0.0% | |||
| EPS-RELATED TEAEs (PROPORTION OF PATIENTS) | |||||
| EPS (including akathisia) | 1.3%‡ | 1.1%‡ | 4.0%‡ | 2.3%‡ | 3.9% (≥1 EPS-related TEAE) |
| Akathisia | 0.0% | 0.3% | 0.6% | 0.0% | 1.6% |
| Dyskinesia | 0.3% | 0.0% | |||
| Safety data from 6-week pivotal trials and a 6-month, open-label safety trial1,2 | |||||
|---|---|---|---|---|---|
| pooled Monotherapy: 6 weeks | Adjunctive (with lithium or valproate): 6 weeks | OPEN-LABEL SAFETY TRIAL, MONOTHERAPY: 6 months* | |||
| SEXUAL DYSFUNCTION (PROPORTION OF PATIENTS) | CAPLYTA (N=372) | Placebo (N=374) | CAPLYTA (N=177) | Placebo (N=175) | CAPLYTA (N=127) |
| Erectile dysfunction† | 0.0% | 0.7% | 0.0% | 0.0% | |
| Libido decreased | 1.1% | 0.3% | 0.6% | 0.0% | |
| Orgasm abnormal | 0.3% | 0.0% | |||
| EPS-RELATED TEAEs (PROPORTION OF PATIENTS) | |||||
| EPS (including akathisia) | 1.3%‡ | 1.1%‡ | 4.0%‡ | 2.3%‡ | 3.9% (≥1 EPS-related TEAE) |
| Akathisia | 0.0% | 0.3% | 0.6% | 0.0% | 1.6% |
| Dyskinesia | 0.3% | 0.0% | |||
No notable changes from baseline on clinician-rated objective measures of movement disorders (AIMS, BARS, SAS).1-3§
*Limitation: This open-label safety extension trial was designed primarily to assess long-term safety and tolerability.2
†Represents male-specific TEAEs.1
‡EPS include akathisia, extrapyramidal disorder, muscle spasms, muscle twitching, musculoskeletal stiffness, restlessness, dyskinesia, tremor, movement disorder, and gait disturbance.1
§The AIMS for dyskinesia ranges from 0 to 28. The BARS for akathisia ranges from 0-14. The SAS for EPS ranges from 0 to 40.1,3
AIMS=Abnormal Involuntary Movement Scale; BARS=Barnes Akathisia Rating Scale; EPS=extrapyramidal symptoms; SAS=Simpson-Angus Scale; TEAE=treatment-emergent adverse event.
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.
Please see additional Important Safety Information, including Boxed WARNINGS, below.
