Caplyta

Drug - Caplyta™ (lumateperone) [Intra-Cellular Therapies, Inc.]

July 2020

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).

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