Caplyta® (lumateperone) has received FDA approval for two new dosages strengths: 10.5mg capsules and 21mg capsules.

• First FDA approved in 2019, Caplyta is indicated to treat schizophrenia, as well as depressive episodes associated with bipolar I or II disorder.
• Typical recommended dosing is 42mg taken once daily, currently available in capsule form. However, patients may require dose reduction if they are also taking moderate or strong CYP3A4 inhibitors, or if they have moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment. Recommended dosing for these patient populations is:
  • 5mg once daily for patients on moderate CYP3A4 inhibitors.
  • 21mg once daily for patients on strong CYP3A4 inhibitors or with moderate or severe hepatic impairment.
• Intra-Cellular Therapies, the manufacturer, plans to launch the new dosage strengths mid-2022.