Lowest Dosage Strength of Caplyta (Lumateperone)
The lowest dosage strength of Caplyta (lumateperone) is 10.5 mg capsules (equivalent to 15 mg of lumateperone tosylate). 1
Available Dosage Strengths
Caplyta is available in three distinct capsule strengths 1:
- 10.5 mg (equivalent to 15 mg lumateperone tosylate) - the lowest strength
- 21 mg (equivalent to 30 mg lumateperone tosylate) - intermediate strength
- 42 mg (equivalent to 60 mg lumateperone tosylate) - standard therapeutic dose
Clinical Context
The FDA-approved therapeutic dose for schizophrenia is 42 mg once daily, which demonstrated statistically significant improvement in PANSS total scores compared to placebo (LSMD -4.2; 95% CI, -7.8 to -0.6; P = .02) in phase 3 trials. 2
The lower dosage strengths (10.5 mg and 21 mg) provide flexibility for dose titration or reduction in specific clinical scenarios, particularly in patients with moderate to severe hepatic impairment (Child-Pugh class B or C), where dosage reduction is recommended. 1
Important Considerations
- Lumateperone exhibits high inter-subject variability in pharmacokinetic parameters, with coefficients of variation for Cmax and AUC ranging from 68% to 97% at steady state. 1
- The absolute bioavailability of lumateperone capsules is approximately 4.4%, with steady state reached in about 5 days with once-daily dosing. 1
- The 28 mg dose (not available as a single capsule strength) showed less robust efficacy in clinical trials compared to the 42 mg dose. 2