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The following safety information outlines important risks and precautions associated with the use of Caplyta (lumateperone). It is crucial to review these points and discuss any concerns with your healthcare provider.

• Higher Risk of Death in Older Adults with Dementia-Related Psychosis: Caplyta is not approved for treating dementia-related psychosis. Use in older adults with dementia can lead to severe side effects, including heart problems, stroke, and infections, which can be fatal. Inform your healthcare provider if dementia is present before starting this medication.

• Worsening Depression and Suicidal Thoughts: Antidepressants like Caplyta may worsen depression or increase suicidal thoughts, particularly in individuals aged 24 and younger. This risk is heightened during the initial weeks of treatment or when the dosage is adjusted. Seek immediate medical attention if you experience suicidal thoughts or unusual behavior changes such as anxiety, panic attacks, or restlessness.

• Neuroleptic Malignant Syndrome (NMS): Caplyta can cause NMS, a rare but serious condition. Symptoms include high fever, muscle stiffness, confusion, and irregular pulse or blood pressure. Stop the medication and seek emergency help if these symptoms occur.

• Movement Disorders: Use of Caplyta may lead to tardive dyskinesia, a potentially permanent movement disorder, with higher risk in older adults, especially women, and those on long-term or high-dose antipsychotic treatment. Report any involuntary movements to your prescriber.

• Metabolic Changes: Caplyta can cause high blood sugar, high cholesterol, and weight gain. Patients with diabetes or at risk should monitor blood sugar levels regularly. Report symptoms like excessive thirst, frequent urination, or weakness to your healthcare provider.

• Low White Blood Cell Count: The medication may lower white blood cell levels, increasing infection risk. Contact your doctor if you experience fever, weakness, or sore throat.

• Blood Pressure and Heartbeat Changes: Caplyta can cause fluctuations in blood pressure and heart rhythm. Caution is advised when standing up suddenly. Discuss with your doctor if you have a history of heart issues and report any fainting or irregular heartbeats.

• Seizure Risk: There is an increased risk of seizures with Caplyta. Inform your healthcare provider if you have a history of seizures or conditions that predispose you to them.

This safety information is crucial for ensuring the appropriate use of Caplyta (lumateperone) and should be regularly reviewed with your healthcare provider.

When taking this medication, you might experience some common side effects such as sleepiness, nausea, dry mouth, dizziness, and headaches. These effects are usually mild and tend to diminish as your body adjusts to the medication. However, if they persist or become bothersome, consult your healthcare provider for guidance.

In some cases, more serious side effects may occur. These include feeling low energy, vomiting, poor appetite, diarrhea, and stomach pain. It’s important to seek medical attention if you experience any of these symptoms, as they could indicate a more significant reaction to the medication.

Rarely, this medication can lead to severe side effects like difficulty swallowing, interrupted breathing during sleep, or signs of infection such as a persistent sore throat or fever. Additionally, it may cause an increase in blood sugar levels, potentially affecting those with diabetes, and might lead to significant weight gain or elevated cholesterol levels, which could increase the risk of heart disease. In very rare instances, conditions such as tardive dyskinesia, characterized by unusual movements, or neuroleptic malignant syndrome, presenting symptoms like fever, muscle stiffness, and confusion, may develop. If you notice symptoms of a severe allergic reaction, such as rash, severe dizziness, or difficulty breathing, seek immediate medical help.

Always be vigilant about any changes in your health while on this medication and report any unusual side effects to your healthcare provider promptly.