Transcript

How is CAPLYTA dosed?

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How is CAPLYTA dosed?
Bottom left copy: Please see Important Safety Information, including Boxed Warnings regarding increased mortality in elderly patients with dementia-related psychosis at the end of this video.
[CAPLYTA logo with 42 mg dosage appears on the right]

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Intra-Cellular Therapies, Inc. is sponsoring this video presentation. The speaker is presenting on behalf of the company and has received compensation for these services. The speaker is presenting information that is consistent with FDA guidelines.
Bottom left copy: Please see Important Safety Information, including Boxed Warnings, and full Prescribing Information via the link adjacent to this video player.

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Brooke Kempf, PMHNP-BC
Hamilton Center
Terre Haute, Indiana
Adjunct Faculty Member
PMHNP Nursing Program
IUPUI School of Nursing
Indianapolis, Indiana

(Brooke Kempf)
The therapeutic dose of CAPLYTA is 42 mg once-daily with no titration required. CAPLYTA 42 mg can be administered at any time of day, with or without food. In terms of administration, while evening doses were studied in the bipolar depression efficacy trials, the Package Insert does not specify when to take CAPLYTA. For patients with moderate or severe hepatic impairment and those taking certain CYP3A4 inhibitors, dosage strengths of 21 mg and 10.5 mg are available for dose adjustment. The recommendation is to reduce CAPLYTA dose to 10.5 mg for concomitant use with strong CYP3A4 inhibitors and to 21 mg with moderate CYP3A4 inhibitors. The latter dose is also recommended for patients with moderate to severe hepatic impairment. It is recommended to avoid concomitant use of CAPLYTA with CYP3A4 inducers.
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42 mg therapeutic dose (icon)
Once-daily (icon)
Titration-free (icon)
Taken orally with or without food (icon)
Reduce dose for:

  • Concomitant use with moderate CYP3A4 inhibitors (21 mg) or with strong CYP3A4 inhibitors (10.5 mg)
  • Patients with moderate or severe hepatic impairment (21 mg)
Avoid concomitant use with CYP3A4 inducers.
Bottom left copy: Caplyta. Prescribing Information. Intra-Cellular Therapies, 2022.

(Brooke Kempf)
For the vast majority of patients, the dose of CAPLYTA is 42 mg once-daily with no titration required.
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For the vast majority of patients, the dose of CAPLYTA is 42 mg once daily with no titration required.

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Summary of Important Safety Information
CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate. CAPLYTA, as with other antipsychotic drugs, has a Boxed Warning that elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. CAPLYTA also has a Boxed Warning that antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.

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

CAPLYTA has additional warnings and precautions that pertain to the antipsychotic drug class. Patients need to be monitored for the following adverse reactions: cerebrovascular events in elderly patients with dementia-related psychosis; neuroleptic malignant syndrome; tardive dyskinesia; metabolic effects (including hyperglycemia, diabetes, dyslipidemia, and weight gain); leukopenia, neutropenia, and agranulocytosis (including fatal cases); orthostatic hypotension and syncope; falls; seizures; potential for cognitive and motor impairment; body temperature dysregulation; and dysphagia.

Concomitant use of CAPLYTA with CYP3A4 inducers should be avoided. When taking CAPLYTA with strong or moderate CYP3A4 inhibitors, reduce the CAPLYTA dose to 10.5 mg and 21 mg, respectively. The lower dose of 21 mg should also be used in patients with moderate or severe hepatic impairment.

The most common adverse reactions in the schizophrenia clinical trials with CAPLYTA vs placebo were somnolence/sedation and dry mouth. In the bipolar depression clinical trials (as monotherapy and as adjunctive therapy), the most common adverse reactions were somnolence/sedation, dizziness, nausea, and dry mouth.

Please see Important Safety Information, including Boxed Warnings, and full Prescribing Information via the link adjacent to this video player.

CAPLYTA is a registered trademark of Intra-Cellular Therapies, Inc.
© 2022 Intra-Cellular Therapies, Inc. All rights reserved.
US-CAP-2200195 06/2022