The Food and Drug Administration (FDA) has approved 2 additional dosage strengths of Caplyta® (lumateperone), 10.5mg and 21mg capsules, to provide dosage recommendations for specific patient populations. 

Caplyta, an atypical antipsychotic, is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorders, as monotherapy and as adjunctive therapy with lithium or valproate. 

Concomitant use of Caplyta with moderate or strong CYP3A4 inhibitors increases lumateperone exposure and requires a dose reduction. The updated prescribing information now states that the recommended dosage for patients receiving strong CYP3A4 inhibitors is 10.5mg, while for those receiving moderate CYP3A4 inhibitors it is 21mg once daily.

Additionally, patients with moderate (Child-Pugh class B) and severe (Child-Pugh class C) hepatic impairment were generally found to have higher exposure to lumateperone than patients with normal hepatic function. The recommended dosage for these patients is 21mg once daily.

Caplyta is currently available in 42mg capsules. The new 10.5mg and 21mg capsules are expected to be available this year (mid-2022).

References

  1. Intra-Cellular Therapies announces FDA approval of new dosage strengths for Caplyta® (lumateperone) for specific patient populations. News release. Intra-Cellular Therapies Inc. Accessed April 25, 2022. https://www.globenewswire.com/news-release/2022/04/25/2427982/30597/en/Intra-Cellular-Therapies-Announces-FDA-Approval-of-New-Dosage-Strengths-for-CAPLYTA-lumateperone-for-Specific-Patient-Populations.html
  2. Caplyta. Package insert. Intra-Cellular Therapies Inc.; 2022. Accessed April 25, 2022. https://www.intracellulartherapies.com/docs/caplyta_pi.pdf