Safety & Tolerability
CAPLYTA demonstrated safety in 2,664 adult patients with schizophrenia and bipolar depression1
Most common adverse reactions in 4- to 6-week schizophrenia inpatient trials (morning dosing)1,3*
|Adverse reaction||CAPLYTA 42 mg (n=406)||Placebo (n=412)|
Incidence of at least 5% of subjects exposed to CAPLYTA and greater than twice the rate of placebo.1
- Somnolence with CAPLYTA was predominantly mild3
- There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in
In 4- to 6-week trials, patients on CAPLYTA experienced metabolic, EPS, prolactin, and weight changes similar to placebo1,3
Antipsychotic drugs have been reported to cause:
- Hyperglycemia, diabetes, dyslipidemia, and weight gain. Blood glucose, weight, and lipids should be monitored periodically during long-term treatment.
- Tardive dyskinesia (TD), which may increase as the duration of treatment and cumulative dose increases, and can develop after brief treatment periods or after discontinuation. See additional Important Safety Information below.
Frequently asked questions about safety
No, CAPLYTA is not a controlled substance.
The CAPLYTA Prescribing Information does not require routine monitoring for liver function.1 Among adverse reactions reported in 4- to 6-week schizophrenia trials with CAPLYTA, hepatic transaminases increased in 2% of patients receiving CAPLYTA 42 mg and in 1% of those receiving placebo.1
In the short-term clinical trials, CAPLYTA was administered in the morning. Among patients who received CAPLYTA, 24% reported somnolence/sedation and most cases were mild. There were no severe cases of somnolence/sedation reported.2
CAPLYTA should not be used with CYP3A4 inducers and moderate or strong CYP3A4 inhibitors. Concomitant use is not recommended1:
- Moderate CYP3A4 inhibitors include, but are not limited to, amprenavir, ciprofloxacin, cyclosporine, diltiazem, erythromycin, fluconazole, fluvoxamine, and verapamil
- Strong CYP3A4 inhibitors include, but are not limited to, clarithromycin, grapefruit juice, itraconazole, voriconazole, nefazodone, ritonavir, and nelfinavir
- CYP3A4 inducers include, but are not limited to, carbamazepine, phenytoin, rifampin, St. John's wort, bosentan, efavirenz, etravirine, modafinil, nafcillin, aprepitant, armodafinil, pioglitazone, and prednisone
QTcF interval was evaluated in a randomized, placebo- and active- (moxifloxacin 400 mg) controlled, four-arm crossover study utilizing concentration-QTc effect modeling in 33 patients with schizophrenia. The placebo-corrected change from baseline QTcF (90% two-sided upper confidence interval) values of 4.9 (8.9) and 15.8 (19.8) ms for the 42 mg and the supratherapeutic dose of 126 mg (three times the recommended daily dosage) CAPLYTA, respectively, administered orally once daily for 5 days.1
References: 1. CAPLYTA full prescribing information, 2022. 2. Rowe W, Edwards JB, Durgam S et al. Somnolence and sedation with lumateperone (ITI-007) treatment: a comparison of morning and evening administration. Poster presented at: College of Psychiatric and Neurologic Pharmacists 2020 Virtual Conference; April 27-May 1, 2020; Virtual.
Safety & Tolerability: