CAPLYTA (Lumateperone) Overview

Preparing for Your Healthcare Provider Visit

• Discuss these questions with your healthcare provider:
  • Can CAPLYTA help with my bipolar depression symptoms?
  • How quickly will CAPLYTA start working?
  • What are the side effects of CAPLYTA, and are they different from other bipolar depression medications?
  • Do I need to take CAPLYTA with food?
  • Will CAPLYTA make me gain weight?
  • Can I take other medications with CAPLYTA?
  • Is CAPLYTA right for me?
• Tip: Keep a notepad for questions to bring up during appointments.

About CAPLYTA

• Usage: For treatment of depressive episodes in adults with bipolar I or II disorder.
• Combination: Can be taken alone or with lithium or valproate.
• Safety: Unknown effectiveness in children.

Important Safety Information

• Elderly Warning: Increased risk of death in elderly with dementia-related psychosis.
• Suicidal Thoughts: Risk of increased suicidal thoughts and actions in children, adolescents, and young adults, especially early in treatment or during dose changes.

Serious Side Effects

• Stroke: Especially in elderly with dementia-related psychosis.
• Neuroleptic Malignant Syndrome (NMS): Symptoms include high fever, confusion, and muscle stiffness.
• Tardive Dyskinesia (TD): Uncontrolled movements that may not go away.
• Metabolic Issues: High blood sugar, diabetes, increased fat levels, weight gain.
• Blood Cell Count: Low white blood cell count potential.
• Blood Pressure: Decreased, leading to dizziness or fainting.
• Falls: Risk due to dizziness and slowed motor skills.
• Seizures: Convulsions can occur.
• Sleepiness: Can affect activities and driving.
• Temperature Regulation: Risk of overheating or dehydration.
• Swallowing Issues: Risk of aspiration.

Common Side Effects

• Sleepiness, dizziness, nausea, dry mouth.

Additional Considerations

• Inform healthcare provider of any history of heart issues, stroke, blood pressure changes, diabetes, cholesterol issues, seizures, or liver/kidney problems.
• CAPLYTA might affect fertility and cause withdrawal symptoms in newborns.
• Breastfeeding considerations: CAPLYTA passes into breast milk.
• Drug interactions: Potential for serious side effects.

Dosage

• Available in 10.5 mg, 21 mg, and 42 mg capsules.

References

• For more detailed information, consult the Medication Guide and contact healthcare providers or Intra-Cellular Therapies, Inc. for further guidance.