Who should not take Caplyta? A comprehensive guide to risks and contraindications

October 10, 2025 •

3 min read

According to the U.S. Food and Drug Administration (FDA), Caplyta (lumateperone) carries a boxed warning that states it is not approved for elderly patients with dementia-related psychosis due to an increased risk of death. Knowing who should not take Caplyta is critical for patient safety, as it involves significant risks that vary based on age, existing health conditions, and other medications.

Quick Summary

Caplyta is contraindicated for individuals with hypersensitivity to its components and comes with serious boxed warnings for elderly patients with dementia-related psychosis and young adults at risk of suicidal thoughts. Patients with liver disease, cardiovascular issues, or those taking certain interacting medications should also exercise caution or avoid it entirely.

Key Points

Elderly patients with dementia-related psychosis: Should not take Caplyta due to a significant increase in the risk of death.
Children, adolescents, and young adults: Are at an increased risk of suicidal thoughts and behaviors, especially when beginning treatment or changing doses.
Hypersensitivity: A known allergy to lumateperone or any other Caplyta component is an absolute contraindication.
Liver impairment: Patients with moderate or severe liver problems should avoid Caplyta, as it can lead to higher drug exposure.
Drug interactions: Strong CYP3A4 inhibitors, inducers, grapefruit juice, and St. John's wort can dangerously alter Caplyta's effectiveness and safety.
Pregnancy and breastfeeding: Caplyta may harm newborns if used during the third trimester and should be used with caution during breastfeeding.
Cardiovascular and seizure risks: Patients with heart disease, low blood pressure, or a history of seizures require careful consideration and monitoring.

Important boxed warnings for Caplyta

Caplyta carries two significant black box warnings from the FDA, indicating serious risks in certain groups.

Increased mortality in elderly patients with dementia-related psychosis

An analysis of studies on similar antipsychotics showed a higher death risk in elderly patients with dementia-related psychosis. Deaths were often linked to cardiovascular or infectious causes.

Key takeaway: Caplyta is not approved for treating dementia-related psychosis in the elderly.
Symptom monitoring: Patients at risk require close observation for symptom changes.

Suicidal thoughts and behaviors in young adults

Short-term studies with similar medications found an increased risk of suicidal thoughts and behaviors in young people up to age 24. This risk is highest early in treatment or after dose changes. Caplyta carries this warning due to its comparable effects.

Monitoring: Young patients and caregivers should watch for new or worsening mood and behavioral changes, including suicidal thoughts.
Action: Report concerning changes to a healthcare provider promptly.

Absolute contraindications for Caplyta

Caplyta is absolutely contraindicated for anyone with a history of hypersensitivity to lumateperone or any other component of the medication. Reactions can include itching and hives. Re-exposure after a reaction can lead to a more severe response.

Important precautions based on patient health status

Certain health conditions can increase the risk of serious side effects with Caplyta.

Moderate to severe liver impairment: Avoid use in patients with moderate or severe liver problems (Child-Pugh class B or C) due to higher drug exposure.
Cardiovascular disease or cerebrovascular disease: Use with caution in patients with a history of heart attack, stroke, or low blood pressure. Caplyta can cause orthostatic hypotension, increasing fall risk.
History of seizures or epilepsy: Caplyta may lower the seizure threshold.
Metabolic problems: Monitor patients with a history of diabetes, high blood sugar, cholesterol, or triglycerides.
Low white blood cell count: Caplyta can lower white blood cells, increasing infection risk. Monitor patients with pre-existing low levels.
Pregnancy and fertility: Caplyta may harm a fetus if used in the third trimester and may affect fertility.
Breastfeeding: The drug passes into breast milk, and effects on infants are not fully known.

Key drug and food interactions to avoid

Caplyta is processed by the CYP3A4 enzyme. Interactions with substances affecting this enzyme can alter Caplyta levels.

Substances to avoid or use with extreme caution:

Strong CYP3A4 Inhibitors: Medications like itraconazole, clarithromycin, and ritonavir can significantly increase Caplyta levels.
Strong CYP3A4 Inducers: Medications like rifampin, carbamazepine, and St. John's wort can decrease Caplyta levels.
Grapefruit juice: Can increase Caplyta levels by inhibiting the CYP3A4 enzyme.

Side effects vs. serious warnings comparison

It's important to differentiate common side effects from serious warnings.


Feature	Common Side Effects	Serious Warnings and Precautions
Symptom examples	Sleepiness, dizziness, nausea, dry mouth	Increased death risk, suicidal ideation, NMS, tardive dyskinesia, metabolic changes, seizures
Affected population	General adult population	Elderly with dementia, young adults, patients with specific comorbidities
Management	Often temporary and manageable.	Requires close monitoring, potential dose adjustment, or discontinuation.
Regulatory Status	Included as adverse reactions	Included in boxed warnings or specific precautions

Conclusion

Discussing Caplyta with a healthcare provider is essential. While effective for schizophrenia and bipolar depression, risks in the elderly with dementia, young adults, and those with certain health issues or taking specific medications are significant. Boxed warnings and precautions highlight the need for careful evaluation.

Important disclaimer

This article is for informational purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider regarding your medical condition, treatment options, and any medications you are taking. Do not stop or change a medication without a doctor's supervision.

Caplyta Prescribing Information

Frequently Asked Questions

No, Caplyta is not approved for and should not be given to elderly patients with dementia-related psychosis due to a boxed warning about an increased risk of death.

Yes, Caplyta carries a boxed warning that it may increase the risk of suicidal thoughts and actions in children, adolescents, and young adults, particularly in the initial stages of treatment.

If you have a known hypersensitivity or allergic reaction to lumateperone or any other component of Caplyta, you should not take this medication.

Caplyta is not known to be safe during pregnancy, and newborns exposed in the third trimester are at risk for extrapyramidal symptoms or withdrawal. It passes into breast milk, and the risks should be discussed with a doctor.

You should avoid grapefruit juice and the herbal supplement St. John's wort, as they can interfere with Caplyta's metabolism and lead to dangerous drug level changes.

Patients with moderate to severe liver impairment (Child-Pugh B or C) should avoid using Caplyta. For those with liver issues, a healthcare provider will need to determine if a reduced dose is appropriate.

Individuals with a history of heart disease, low blood pressure, seizures, diabetes, or a low white blood cell count should use Caplyta with caution and under close medical supervision.