Drug - Caplyta™ (lumateperone) [Intra-Cellular Therapies, Inc.]
Therapeutic area - Antipsychotics
Initial approval criteria:
Patient must be ≥ 18 years of age; AND
- Patient must have a diagnosis of schizophrenia based upon DSM-5 criteria; AND
- Lumateperone is NOT being used for dementia-related psychosis; AND
- Patient does NOT have moderate to severe hepatic impairment (Child-Pugh classes B or C); AND
- Patient is NOT taking any of the following drugs with clinically relevant interactions:
- Cytochrome P450 3A4 (CYP3A4) inducers (e.g., carbamazepine, phenytoin, rifampin, efavirenz, etravirine, modafinil, armodafinil, pioglitazone, prednisone); OR
- Moderate to strong CYP3A4 inhibitors (e.g., amprenavir, ciprofloxacin, cyclosporine, diltiazem, fluvoxamine, verapamil); OR
- UGT inhibitors (e.g., valproic acid, probenecid); AND
- Patient has tried and failed ≥ 2 preferred atypical antipsychotics.
- Patient must continue to meet the above criteria; AND
- Patient must have disease improvement and/or stabilization; AND
- Patient has NOT experienced any treatment-restricting adverse effects (e.g., agranulocytosis, body temperature dysregulation, cognitive/motor impairment, leukopenia, metabolic changes, neuroleptic malignant syndrome, neutropenia, orthostatic hypotension/syncope, tardive dyskinesia).
MHCP Provider Call Center 651-431-2700 or 800-366-5411