Caplyta's Effect on Blood Glucose
Caplyta (lumateperone) can cause high blood sugar (hyperglycemia) and diabetes, requiring blood glucose monitoring before starting treatment, soon after initiation, and regularly during long-term therapy. 1
Direct Metabolic Effects
The FDA-approved drug label explicitly warns that Caplyta may cause problems with metabolism, specifically:
- High blood sugar (hyperglycemia) and diabetes can occur in some people taking Caplyta 1
- Extremely high blood sugar can lead to coma or death 1
- Healthcare providers must check blood sugar before starting or soon after starting Caplyta, then regularly during long-term treatment 1
Clinical Monitoring Requirements
Patients should be monitored for the following symptoms of high blood sugar during Caplyta treatment: 1
- Feeling very thirsty
- Needing to urinate more than usual
- Feeling very hungry
- Feeling weak or tired
- Feeling sick to the stomach
- Feeling confused or fruity-smelling breath
Additional Metabolic Concerns
Beyond glucose effects, Caplyta causes other metabolic disturbances that require monitoring: 1
- Increased fat levels (cholesterol and triglycerides) - requires checking before or soon after starting Caplyta, then periodically during treatment 1
- Weight gain - requires checking weight before starting and often during treatment 1
Magnitude of Effect
While the FDA label does not quantify the exact magnitude of blood glucose elevation, the requirement for regular monitoring and the warning about potential progression to coma or death indicates this is a clinically significant adverse effect that requires vigilant surveillance. 1
Clinical Context
This metabolic profile is consistent with second-generation antipsychotics as a class, though lumateperone was designed to have a more favorable safety profile compared to older agents. 2, 3 The clinical trials demonstrated good tolerability, but metabolic monitoring remains essential as increases in blood sugar can develop during treatment. 1