Consistent safety and tolerability across bipolar depression and schizophrenia trials in adults1,2
Across 3 indications, CAPLYTA was similar to placebo in1,2*:
- Extrapyramidal symptoms
- Akathisia
- Metabolic effects
- Prolactin levels
- Weight change
*Based on data from individual studies that were 4- to 6-weeks in duration.
Antipsychotic drugs have been reported to cause:
- Tardive Dyskinesia (TD), 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, or after treatment discontinuation. Given these considerations, CAPLYTA should be prescribed in a manner most likely to reduce the risk of TD. 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.
Please see additional Important Safety Information, including Boxed Warnings, below.
CAPLYTA demonstrated safety in 2,664 adult patients with bipolar depression and schizophrenia1
- In clinical studies, there was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in patients treated with CAPLYTA.1
- In bipolar depression trials, the most common adverse reactions with CAPLYTA vs placebo were (monotherapy, adjunctive therapy): somnolence/sedation (13% vs 3%, 13% vs 3%), dizziness (8% vs 4%, 11% vs 2%), nausea (8% vs 3%, 9% vs 4%), and dry mouth (5% vs 1%, 5% vs 1%). Somnolence was predominantly mild.1
- In schizophrenia trials, the most common adverse reactions with CAPLYTA vs placebo were somnolence/sedation (24% vs 10%) and dry mouth (6% vs 2%). Somnolence was predominantly mild.1
Antipsychotic drugs have been reported to cause:
- Potential for Cognitive and Motor Impairment. Advise patients to use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
Please see additional Important Safety Information, including Boxed Warnings, below.
Explore select safety data for each indication by selecting a tab below
Weight and metabolic effects
See the short-term and long-term data in bipolar depression studies.
Weight & Metabolic EffectsConsistent safety and tolerability
In adults with bipolar I or bipolar II depression.
Most CommonAdverse Events
Frequently Asked Questions
Most common adverse reactions relating to sexual side effects reported in a 6-week bipolar depression trial2
Bipolar Depression
Monotherapy
Adjunctive
(with Lithium or Valproate)
Adverse reactions reported related to sexual side effects | CAPLYTA (n=372) | Placebo (n=374) | CAPLYTA (n=177) | Placebo (n=175) |
---|---|---|---|---|
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% | 0.0% | 0.0% |
Bipolar Depression
Monotherapy
Adverse reactions reported related to sexual side effects | CAPLYTA (n=372) | Placebo (n=374) |
---|---|---|
Erectile dysfunction† | 0.0% | 0.7% |
Libido decreased | 1.1% | 0.3% |
Orgasm abnormal | 0.3% | 0.0% |
Bipolar Depression
Adjunctive
(with Lithium or Valproate)
Adverse reactions reported related to sexual side effects | CAPLYTA (n=177) | Placebo (n=175) |
---|---|---|
Erectile dysfunction† | 0.0% | 0.0% |
Libido decreased | 0.6% | 0.0% |
Orgasm abnormal | 0.0% | 0.0% |
Most common adverse reactions relating to sexual side effects reported in 4- to 6-week schizophrenia trials2
Schizophrenia
Adverse reactions reported related to sexual side effects | CAPLYTA (n=406) | Placebo (n=412) |
---|---|---|
Erectile dysfunction† | 0.7% | 0.5% |
Libido decreased | 0.0% | 0.0% |
Erection increased | 0.0% | 0.0% |
Spontaneous penile erection | 0.0% | 0.0% |
Schizophrenia
Adverse reactions reported related to sexual side effects | CAPLYTA (n=406) | Placebo (n=412) |
---|---|---|
Erectile dysfunction† | 0.7% | 0.5% |
Libido decreased | 0.0% | 0.0% |
Erection increased | 0.0% | 0.0% |
Spontaneous penile erection | 0.0% | 0.0% |
†Represents male-specific treatment-emergent adverse events at 4- to 6-weeks.