skip to content
Primary navigation


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.

Renewal criteria:

  • 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).

Quantity limits:

  • 30 capsules/30 days


MHCP Provider Call Center 651-431-2700 or 800-366-5411

back to top