CAPLYTA

CAPLYTA- lumateperone capsule
Intra-Cellular Therapies, Inc

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].

Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.2)]. The safety and effectiveness of CAPLYTA have not been established in pediatric patients [see Use in Specific Populations (8.4)].

1 INDICATIONS AND USAGE

CAPLYTA is indicated for the treatment of:

  • Schizophrenia in adults [see Clinical Studies (14.1)].
  • Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate [see Clinical Studies (14.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosage of CAPLYTA is 42 mg administered orally once daily with or without food. Dose titration is not required.

2.2 Dosage Recommendations for Concomitant Use with CYP3A4 Inducers and Moderate or Strong CYP3A4 Inhibitors

Coadministration with CYP3A4 Inducers

Avoid concomitant use of CAPLYTA with CYP3A4 inducers [see Drug Interactions (7.1)].

Coadministration with Moderate or Strong CYP3A4 Inhibitors

Avoid concomitant use of CAPLYTA with moderate or strong CYP3A4 inhibitors [see Drug Interactions (7.1)].

2.3 Dosage Recommendations for Patients with Hepatic Impairment

Avoid use of CAPLYTA in patients with moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations (8.6)].

3 DOSAGE FORMS AND STRENGTHS

CAPLYTA capsules are available as a 42 mg strength (equivalent to 60 mg lumateperone tosylate). The capsule has a blue cap and opaque white body imprinted with “ITI-007 42 mg.”

4 CONTRAINDICATIONS

CAPLYTA is contraindicated in patients with history of hypersensitivity reaction to lumateperone. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

5 WARNINGS AND PRECAUTIONS

5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in placebo-treated patients. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning, Warnings and Precautions (5.3)].

5.2 Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1.

Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric* and Adult Patients
Age Range

Drug-Placebo Difference in Number of Patients of Suicidal Thoughts

or Behaviors per 1000 Patients Treated

Increases Compared to Placebo
<18 years old 14 additional patients
18-24 years old 5 additional patients
Decreases Compared to Placebo
25-64 years old 1 fewer patient
>65 years old 6 fewer patients

* CAPLYTA is not approved for use in pediatric patients.

It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.

Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing CAPLYTA, in patients whose depression is persistently worse, or who are experiencing suicidal thoughts or behaviors.

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