Caplyta (Lumateperone) Dosing
The recommended dosage of Caplyta is 42 mg administered orally once daily, with or without food, and no dose titration is required. 1
Standard Dosing
- Adults with schizophrenia: 42 mg orally once daily 1
- Administration can be with or without food 1
- No titration necessary—patients start at the therapeutic dose 1
Dose Adjustments for Drug Interactions
Strong CYP3A4 Inhibitors
- Reduce dose to 10.5 mg once daily when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) 1
Moderate CYP3A4 Inhibitors
- Reduce dose to 21 mg once daily when coadministered with moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, fluconazole) 1
Dose Adjustments for Hepatic Impairment
- Patients with moderate or severe hepatic impairment (Child-Pugh class B or C): 21 mg once daily 1
- No adjustment needed for mild hepatic impairment 1
Clinical Context
Lumateperone represents a mechanistically novel antipsychotic that simultaneously modulates serotonin, dopamine, and glutamate neurotransmission, distinguishing it from traditional first- and second-generation antipsychotics 2. The 42 mg dose was established through clinical trials demonstrating significant improvement in PANSS scores compared to placebo, with a favorable tolerability profile including minimal extrapyramidal symptoms and metabolic effects 3, 4.
Key Safety Considerations
- Most common adverse effects at the 42 mg dose include somnolence (6.6%), headache (5.3%), and dry mouth (5.3%) 4
- Extrapyramidal symptoms are rare (1.0% incidence), significantly lower than traditional antipsychotics 4
- Metabolic parameters typically improve during treatment, with significant decreases in total cholesterol, LDL cholesterol, body weight, and prolactin levels 4
- The fixed 42 mg dose eliminates the complexity and delay associated with dose titration seen with many other antipsychotics 1