What is the seizure risk associated with Caplyta (Lumateperone)?

Seizure Risk Associated with Caplyta (Lumateperone)

Caplyta (lumateperone) carries a low seizure risk similar to most atypical antipsychotics, with seizures being rare (usually <1%) when therapeutic doses are used. 1

Seizure Risk Profile

Lumateperone's FDA label specifically mentions seizure risk in section 5.10, stating:

• "Like other antipsychotic drugs, CAPLYTA may cause seizures" 2
• "The risk is greatest in patients with a history of seizures or with conditions that lower the seizure threshold" 2
• "Conditions that lower the seizure threshold may be more prevalent in older patients" 2

Risk Comparison with Other Antipsychotics

Antipsychotic medications generally have been noted to lower the seizure threshold in a dose-dependent manner. However, antipsychotic-induced seizures are rare (usually <1%) when therapeutic doses are used, with the exception of clozapine, which has a 5% incidence of seizures at high dosages 1.

The seizure risk hierarchy among antipsychotics is:

• Higher risk: Clozapine (5% at high doses)
• Lower risk: Most other antipsychotics including lumateperone (<1%)

Risk Factors for Seizures with Antipsychotics

Several factors increase the risk of seizures when taking antipsychotics like Caplyta:

• History of seizure disorders 2
• Advanced age 2
• Conditions that lower seizure threshold 2
• Higher doses (dose-dependent risk) 1, 3
• Overdose situations (significantly increased risk) 3

Clinical Considerations

Patient Monitoring

For patients prescribed Caplyta:

• Carefully evaluate seizure history before initiating treatment
• Use with caution in patients with pre-existing seizure disorders
• Consider closer monitoring in elderly patients who may have a lower seizure threshold
• Maintain the lowest effective dose to minimize seizure risk

Warning Signs

Monitor for potential warning signs that may precede seizure activity:

• Changes in mental status
• Unusual movements or sensations
• Confusion or disorientation

Special Populations

Patients with Seizure Disorders

The FDA label specifically cautions that "The risk is greatest in patients with a history of seizures or with conditions that lower the seizure threshold" 2. While lumateperone hasn't been specifically studied in patients with seizure disorders, caution is warranted based on the general class effect of antipsychotics.

Elderly Patients

The FDA label notes that "Conditions that lower the seizure threshold may be more prevalent in older patients" 2, suggesting extra vigilance in this population.

Practical Management

If a patient on Caplyta experiences a seizure:

1. Ensure patient safety during the seizure
2. Evaluate for other potential causes
3. Consider dose reduction or medication change if seizures are attributed to Caplyta
4. Consult with neurology for patients with recurrent seizures

Conclusion

While Caplyta carries a seizure warning like other antipsychotics, its risk appears to be in the lower range (<1%) when used at therapeutic doses. This risk should be weighed against the benefits of treatment, particularly in patients with risk factors such as a history of seizures or advanced age.