WARNING

Caplyta (lumateperone) is an antipsychotic medication used primarily in the treatment of schizophrenia. Like all medications, it carries certain risks that should be considered:

• Side Effects: Common side effects of Caplyta include drowsiness, dizziness, dry mouth, and weight gain. Less common but more serious side effects may include changes in heart rhythm, allergic reactions, and potentially severe neurological effects.
• Metabolic Changes: Antipsychotic medications like Caplyta can sometimes lead to metabolic changes such as increased blood sugar levels, cholesterol, and weight gain. These changes can increase the risk of diabetes and heart disease.
• Movement Disorders: Some people may experience movement disorders such as tardive dyskinesia, which involves involuntary movements of the face and body.
• Neurological Effects: There may be a risk of neuroleptic malignant syndrome (NMS), a rare but serious condition characterized by fever, muscle rigidity, and confusion.
• Interaction with Other Medications: Caplyta can interact with other medications, potentially increasing or decreasing their effects or causing other complications. It’s important to inform your doctor about all medications you are taking.
• Pregnancy and Breastfeeding: The effects of Caplyta during pregnancy and breastfeeding are not well-studied. It should only be used if clearly needed and under the guidance of a healthcare provider.
• Psychiatric Effects: Antipsychotic medications can sometimes worsen symptoms of certain psychiatric conditions or cause new symptoms, such as depression or suicidal thoughts.
• Long-term Use: Long-term use of antipsychotic medications may lead to a variety of health risks, including cognitive decline and movement disorders.

It’s crucial for individuals considering or using Caplyta to discuss these risks with their healthcare provider. They can provide personalized guidance based on your medical history and specific health needs.

Why is this medication prescribed?

Caplyta (lumateperone) is prescribed primarily for the treatment of schizophrenia in adults. Schizophrenia is a mental disorder characterized by distorted thinking, hallucinations, delusions, and disrupted emotions and behaviors. Caplyta is an antipsychotic medication that helps to manage the symptoms of schizophrenia by affecting certain neurotransmitters in the brain, particularly dopamine and serotonin receptors.

How should this medicine be used?

Caplyta is typically available as oral tablets and is taken once daily with food. Here are some important points regarding its usage:

• Dosage: The recommended starting dose of Caplyta is usually 42 mg once daily. Your doctor may adjust the dose based on your individual response and tolerability.
• Administration: Caplyta tablets should be swallowed whole with a glass of water. It can be taken with or without food, but taking it with food can help reduce the likelihood of stomach upset.
• Consistency: It’s important to take Caplyta consistently at the same time each day, as directed by your healthcare provider. This helps maintain steady levels of the medication in your bloodstream.
• Follow Doctor’s Instructions: Always follow your doctor’s instructions regarding dosage and usage. Do not adjust your dose or stop taking Caplyta without consulting your doctor, even if you feel better. Abruptly stopping antipsychotic medications can lead to withdrawal symptoms or a return of symptoms.
• Monitoring: Your doctor may periodically monitor your response to Caplyta and adjust your dose if necessary. They may also monitor for any side effects or changes in your health.
• Other Medications: Inform your doctor about all other medications, supplements, or herbal products you are taking, as some may interact with Caplyta.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of using Caplyta with your doctor. The effects of Caplyta during pregnancy and breastfeeding are not well-studied.
• Storage: Store Caplyta at room temperature away from moisture and heat.

Always consult your healthcare provider if you have any questions or concerns about the proper use of Caplyta or if you experience any side effects while taking it.

Other uses for this medicine

Apart from schizophrenia, Caplyta is not approved for other uses by regulatory authorities like the FDA (Food and Drug Administration) in the United States. Its effectiveness and safety in other conditions have not been extensively studied or established.

What special precautions should I follow?

When taking Caplyta, it’s important to follow specific precautions to ensure safe and effective use:

• Medical History: Inform your healthcare provider about your complete medical history, especially if you have a history of heart problems, liver disease, low white blood cell counts, seizures, or other psychiatric disorders.
• Allergies: Tell your doctor if you have any allergies to lumateperone or any other medications.
• Pregnancy and Breastfeeding: Caplyta should only be used during pregnancy if clearly needed. The potential risks to the fetus are not well-established. It is also not recommended during breastfeeding, as it may pass into breast milk.
• Driving and Operating Machinery: Caplyta may cause drowsiness or dizziness. Avoid driving, operating machinery, or engaging in activities requiring mental alertness until you know how Caplyta affects you.
• Alcohol and Other Drugs: Avoid alcohol while taking Caplyta, as it can increase the risk of side effects such as dizziness and drowsiness. Inform your doctor about all other medications, including over-the-counter drugs, supplements, and herbal products, as they may interact with Caplyta.
• Blood Tests: Your doctor may perform periodic blood tests to monitor your blood counts and liver function while you are taking Caplyta.
• Suicidal Thoughts: Like other antipsychotic medications, Caplyta may increase the risk of suicidal thoughts and behaviors, especially in young adults. Monitor for any changes in mood or behavior and inform your doctor immediately if you experience worsening depression or suicidal thoughts.
• Heat Exposure: Caplyta may impair the body’s ability to regulate temperature. Avoid overheating or dehydration, especially in hot weather or during exercise.
• Elderly Patients: Elderly patients may be more sensitive to the side effects of Caplyta, such as dizziness and falls.

Always follow your doctor’s instructions carefully when taking Caplyta. If you have any questions or concerns about its use or precautions, do not hesitate to discuss them with your healthcare provider.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Caplyta. However, maintaining a healthy and balanced diet can support overall health and well-being, which is beneficial when taking any medication. If you have concerns about diet or nutrition while taking Caplyta, discuss them with your healthcare provider or a registered dietitian.

What should I do if I forget a dose?

If you miss a dose of Caplyta, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Caplyta (lumateperone), like all medications, can cause side effects. It’s important to note that not everyone will experience these side effects, and their severity can vary. Here are some potential side effects associated with Caplyta:

• Common Side Effects:
  • Drowsiness
  • Dizziness
  • Dry mouth
  • Increased weight
• Less Common Side Effects:
  • Nausea
  • Fatigue
  • Constipation
  • Restlessness or agitation
  • Tremor
  • Blurred vision
• Serious Side Effects (Rare, but may require immediate medical attention):
  • Changes in heart rhythm (e.g., prolonged QT interval)
  • Allergic reactions (symptoms may include rash, itching/swelling, severe dizziness, trouble breathing)
  • Neuroleptic malignant syndrome (NMS), characterized by fever, muscle rigidity, confusion
  • Tardive dyskinesia (involuntary movements, especially of the face)
  • Seizures
  • Suicidal thoughts or behaviors (especially in younger adults)
• Metabolic Effects:
  • Increased blood sugar levels (hyperglycemia)
  • Increased cholesterol levels
  • Weight gain
• Other Effects:
  • Impaired temperature regulation (especially in hot weather)
  • Changes in blood pressure
  • Difficulty swallowing (dysphagia)

It’s important to report any unusual or bothersome side effects to your healthcare provider promptly. They can provide guidance on managing side effects and determine if any adjustments to your treatment plan are necessary.

If you experience severe side effects or signs of an allergic reaction (such as rash, itching/swelling, severe dizziness, trouble breathing), seek immediate medical attention.

Always follow your doctor’s instructions carefully regarding the use of Caplyta and do not hesitate to discuss any concerns you have about side effects or your overall treatment.

What should I know about storage and disposal of this medication?

Storage and Disposal of Caplyta:

• Storage:
  • Store Caplyta tablets at room temperature between 20°C to 25°C (68°F to 77°F).
  • Keep the medication in its original container, tightly closed, and away from moisture and heat.
  • Do not store Caplyta in the bathroom or in a humid environment.
• Disposal:
  • Dispose of any unused or expired Caplyta tablets according to local regulations and guidelines.
  • Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Proper disposal helps prevent accidental ingestion by pets, children, or others.

In case of emergency/overdose

• Emergency Situation: If you suspect an overdose or experience severe symptoms such as difficulty breathing, seizures, loss of consciousness, or severe dizziness, call emergency services (911 in the United States) immediately. Inform the healthcare professionals of the amount of Caplyta taken, when it was taken, and any other relevant information.
• Overdose Symptoms: Overdose symptoms may include severe drowsiness, confusion, agitation, hallucinations, rapid heart rate, and fainting.

What other information should I know?

• Follow-up Appointments: Attend all scheduled appointments with your healthcare provider for monitoring and evaluation of your response to Caplyta.
• Lab Tests: Your doctor may perform periodic blood tests to monitor your liver function, blood cell counts, and other parameters during treatment with Caplyta.
• Diet and Lifestyle: Maintain a healthy lifestyle, including regular exercise and a balanced diet, to support overall health while taking Caplyta.
• Missed Dose: If you forget to take a dose of Caplyta, take it as soon as you remember unless it is almost time for your next scheduled dose. Do not double up on doses to make up for a missed one.
• Alcohol: Avoid consuming alcohol while taking Caplyta, as it can increase the risk of side effects such as drowsiness and dizziness.
• Medical Alert: Inform healthcare providers, including dentists and emergency medical personnel, that you are taking Caplyta before any procedures or treatments.
• Pregnancy and Breastfeeding: Discuss the risks and benefits of using Caplyta if you are pregnant, planning to become pregnant, or breastfeeding. The effects of Caplyta on pregnancy and breastfeeding are not well-studied.
• Driving and Operating Machinery: Caplyta may cause drowsiness or dizziness. Avoid driving or operating machinery until you know how Caplyta affects you.
• Psychiatric Effects: Monitor for changes in mood, behavior, or suicidal thoughts. Contact your doctor immediately if you experience new or worsening depression, anxiety, agitation, or other psychiatric symptoms.

Always keep Caplyta and all medications out of reach of children and pets. If you have any questions or concerns about the use of Caplyta or need further clarification, consult your healthcare provider or pharmacist for guidance tailored to your individual needs.