CAPLYTA

Lumateperone 42mg, Oral capsule

Alcohol

· Severity: Moderate

· Notes for Consumers: Limit alcohol-containing drinks while taking this medicine. Using this drug along with alcohol can lead to serious side effects. You may feel drowsy or more tired when taking these drugs together. Do not drive or operate machinery until you know how this drug affects you, and especially if you are drinking alcohol-containing beverages. If you notice slurred speech, confusion, severe weakness, or difficulty breathing, contact your health care provider immediately.

· Notes for Professionals: Alcohol may potentiate the CNS effects of the atypical antipsychotics, which have the potential to cause increased sedation or to impair judgment, thinking, or motor skills. Patients should be appropriately cautioned; some manufacturers recommend alcohol avoidance during treatment.

Lumateperone 42mg, Oral capsule

Marijuana

· Severity: Major

· Notes for Consumers: Avoid this combination. It may cause your condition to get worse. Marijuana may also decrease the efficacy of this medicine, making it not work as well for you. Do not drive or operate machinery until you know how this combination will affect you. Contact your health care provider right away if you notice unusual changes in moods or behaviors of any type.

· Notes for Professionals: It is recommended that patients avoid the use of marijuana, by any route, if they are treated for a psychiatric history, including psychosis and bipolar disorder, as the cannabinoids (the psychoactive ingredients, such as THC) in marijuana can produce psychotoxic effects and may exacerbate psychiatric disorders. A high frequency of use and use of products with high-potency of THC are potential risk factors for psychiatric effects. Additive CNS effects, such as sedation or CNS depression are also possible. Clinical studies suggest that cannabis use may reduce the efficacy of some antipsychotic drugs. In addition, several cannabinoids in marijuana appear to influence the activity of CYP enzymes and P-glycoprotein, which may alter the concentrations of antipsychotics and influence either safety or efficacy.

Lumateperone 42mg, Oral capsule

Grapefruit juice

· Severity: Major

· Notes for Consumers: Avoid grapefruit juice and grapefruit while taking this medicine. Using this drug along with grapefruit juice can lead to an increased risk for side effects from Lumateperone. You may feel drowsy or more tired, for example. Do not drive, use machinery, or do anything that needs mental alertness until you know how Lumateperone affects you. Using this drug with grapefruit juice may increase the risk of side effects such as drowsiness, dizziness, nausea, vomiting, low blood pressure, or falls. If you experience slurred speech, confusion, excess drowsiness, dizziness, low blood pressure, falls, or other serious effects, contact your health care provider immediately.

· Notes for Professionals: It is advisable to have patients avoid grapefruit juice and grapefruit during treatment with lumateperone due to an expected significant increase in lumateperone exposure and risk for side effects. Lumateperone is a CYP3A4 substrate; grapefruit juice is a strong CYP3A4 inhibitor. Coadministration of lumateperone with another strong CYP3A4 inhibitor increased lumateperone exposure by approximately 4-fold.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>