| • | | 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 are reasonably certain CAPLYTA therapy does not affect them adversely. |
| • | | 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 and moderate or strong CYP3A4 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%).
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About CAPLYTA (lumateperone)
CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia of adults (42mg/day).
The mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown. However, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.
CAPLYTA is being developed for the treatment of bipolar depression, behavioral disturbances in patients with dementia, including Alzheimer’s disease, depression and other neuropsychiatric and neurological disorders. CAPLYTA has not been demonstrated to be safe and effective in these other areas.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company foundedon Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.