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EXPERT INSIGHTS: CAPLYTA® (LUMATEPERONE) FOR BIPOLAR I AND II DEPRESSION IN
ADULTS


CLINICAL PHARMACOLOGY OF CAPLYTA FOR ADULTS WITH BIPOLAR I OR II DEPRESSION

US-CAP-2200201_ CAPLYTA_BPD_2022 KOL Videos_Module 2_Pharmacology_HCP


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Watch Dr Jain dive deeper into the pharmacologic profile of CAPLTYA and its
indication for bipolar depression.
Featured Faculty

Rakesh Jain, MD, MPH

Clinical Professor, Department of Psychiatry
Texas Tech University Health Sciences Center

School of Medicine, Permian Basin

Midland, Texas
Physician in Private Practice
Austin, Texas

VIEW BIO

Interested in attending a live event?
Click here to learn more.
ADDITIONAL ENLYTEN
VIDEO SERIES

Short- and Long-Term Clinical Safety: CAPLYTA in Adults with Bipolar I or II
Depression
Exploring the Clinical Efficacy of CAPLYTA for Adults with Bipolar Depression
(Bipolar I and II)
What Are the Effects of CAPLYTA on Weight and Metabolic Parameters?
How Can CAPLYTA Be Integrated into Clinical Practice?
What Comorbid Conditions Are Most Prevalent in Patients with Bipolar Disorder?
How Were Quality of Life Data Measured in the CAPLYTA Trials?
What Are the Long-Term Safety Data for CAPLYTA in Bipolar Depression?
How Is CAPLYTA Dosed?
Clinical Differences Between Bipolar I and Bipolar II Depression
Impact of CAPLYTA on Depressive Symptoms and Disease Severity
Misdiagnosis of Bipolar Depression
Attributes of CAPLYTA for Bipolar Depression



Top Bottom

CAPLYTA 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.


IMPORTANT SAFETY INFORMATION

Boxed Warnings:
 * 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.
 * 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. The safety and effectiveness of CAPLYTA have
   not been established in pediatric patients.

Contraindications: 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.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

 * Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related
   Psychosis, including stroke and transient ischemic attack. See Boxed Warning
   above.
 * Neuroleptic Malignant Syndrome, which is a potentially fatal reaction. Signs
   and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic
   instability, elevated creatinine phosphokinase, myoglobinuria (and/or
   rhabdomyolysis), and acute renal failure. Manage with immediate
   discontinuation of CAPLYTA and provide intensive symptomatic treatment and
   monitoring.
 * Tardive Dyskinesia (TD), a syndrome of potentially irreversible, dyskinetic,
   and involuntary movements which may increase as the duration of treatment and
   total cumulative dose increases. The syndrome can develop after a relatively
   brief treatment period, even at low doses, or after treatment
   discontinuation. Given these considerations, CAPLYTA should be prescribed in
   a manner most likely to reduce the risk of TD. Discontinue CAPLYTA if
   clinically appropriate.
 * Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia,
   and weight gain. Hyperglycemia, in some cases extreme and associated with
   ketoacidosis, hyperosmolar coma or death, has been reported in patients
   treated with antipsychotics. Measure weight and assess fasting plasma glucose
   and lipids when initiating CAPLYTA and monitor periodically during long-term
   treatment.
 * Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Perform
   complete blood counts in patients with pre-existing low white blood cell
   count (WBC) or history of leukopenia or neutropenia. Discontinue CAPLYTA if
   clinically significant decline in WBC occurs in absence of other causative
   factors.
 * Orthostatic Hypotension and Syncope. Monitor heart rate and blood pressure
   and warn patients with known cardiovascular or cerebrovascular disease.
   Orthostatic vital signs should be monitored in patients who are vulnerable to
   hypotension.
 * Falls. CAPLYTA may cause somnolence, postural hypotension, and motor and/or
   sensory instability, which may lead to falls and, consequently, fractures and
   other injuries. Assess patients for risk when using CAPLYTA.
 * Seizures. Use CAPLYTA cautiously in patients with a history of seizures or
   with conditions that lower seizure threshold.
 * Potential for Cognitive and Motor Impairment. Advise patients to use caution
   when operating machinery or motor vehicles until they know how CAPLYTA
   affects them.
 * Body Temperature Dysregulation. Use CAPLYTA with caution in patients who may
   experience conditions that may increase core body temperature such as
   strenuous exercise, extreme heat, dehydration, or concomitant
   anticholinergics.
 * Dysphagia. Use CAPLYTA with caution in patients at risk for aspiration.

Drug Interactions: Avoid concomitant use with CYP3A4 inducers. Reduce dose for
concomitant use with strong CYP3A4 inhibitors (10.5 mg) or moderate CYP3A4
inhibitors (21 mg).

Special Populations: Neonates exposed to antipsychotic drugs during the third
trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms
following delivery. Breastfeeding is not recommended. Reduce dose for patients
with moderate or severe hepatic impairment (21 mg).

Adverse Reactions: The most common adverse reactions in clinical trials with
CAPLYTA vs placebo were:

 * Schizophrenia: somnolence/sedation (24% vs 10%) and dry mouth (6% vs 2%).
 * Bipolar Depression (Monotherapy, Adjunctive therapy): somnolence/sedation
   (13% vs 3%, 13% vs 3%), dizziness (8% vs 4%, 11% vs 2%), nausea (8% vs 3%, 9%
   vs 4%), and dry mouth (5% vs 1%, 5% vs 1%).

CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

Please see full Prescribing Information, including Boxed Warnings.

Click here for WAC disclosure and pricing transparency.

References: 1. Bipolar disorder. National Institute of Mental Health. Accessed
June 17, 2022. https://www.nimh.nih.gov/health/statistics/bipolar-disorder.html
2. State population by characteristics: 2010-2020. United States Census Bureau.
July 2020. Accessed June 17, 2022.
https://www.census.gov/programs-surveys/popest/technical-documentation/research/evaluation-estimates/
2020-evaluation-estimates/2010s-state-detail.html 3. Forte A, Baldessarini RJ,
Tondo L, et al. Long-term morbidity in bipolar-I, bipolar-II, and unipolar major
depressive disorders. J Affect Disord. 2015;178:71-78. 4. CAPLYTA prescribing
information. Intra-cellular Therapies; 2022.

CAPLYTA is a registered trademark of Intra-Cellular Therapies, Inc.
All other trademarks and registered trademarks are property of their respective
owners.
© 2023 Intra-Cellular Therapies, Inc. All rights reserved. US-CAP-2300215  04/23

The site is published by ConneXion360, LLC, and is intended for healthcare
professionals in the United States only.

Your use of information on the site and your registration for services and
events offered through this site are subject to the ConneXion360 Terms of Use
and its Privacy Policy.

Do Not Sell My Personal Information | ­1-877-238-8500­

Top Bottom

CAPLYTA 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.


IMPORTANT SAFETY INFORMATION

Boxed Warnings:
 * 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.
 * 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. The safety and effectiveness of CAPLYTA have
   not been established in pediatric patients.

Contraindications: 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.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

 * Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related
   Psychosis, including stroke and transient ischemic attack. See Boxed Warning
   above.
 * Neuroleptic Malignant Syndrome, which is a potentially fatal reaction. Signs
   and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic
   instability, elevated creatinine phosphokinase, myoglobinuria (and/or
   rhabdomyolysis), and acute renal failure. Manage with immediate
   discontinuation of CAPLYTA and provide intensive symptomatic treatment and
   monitoring.
 * Tardive Dyskinesia (TD), a syndrome of potentially irreversible, dyskinetic,
   and involuntary movements which may increase as the duration of treatment and
   total cumulative dose increases. The syndrome can develop after a relatively
   brief treatment period, even at low doses, or after treatment
   discontinuation. Given these considerations, CAPLYTA should be prescribed in
   a manner most likely to reduce the risk of TD. Discontinue CAPLYTA if
   clinically appropriate.
 * Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia,
   and weight gain. Hyperglycemia, in some cases extreme and associated with
   ketoacidosis, hyperosmolar coma or death, has been reported in patients
   treated with antipsychotics. Measure weight and assess fasting plasma glucose
   and lipids when initiating CAPLYTA and monitor periodically during long-term
   treatment.
 * Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Perform
   complete blood counts in patients with pre-existing low white blood cell
   count (WBC) or history of leukopenia or neutropenia. Discontinue CAPLYTA if
   clinically significant decline in WBC occurs in absence of other causative
   factors.
 * Orthostatic Hypotension and Syncope. Monitor heart rate and blood pressure
   and warn patients with known cardiovascular or cerebrovascular disease.
   Orthostatic vital signs should be monitored in patients who are vulnerable to
   hypotension.
 * Falls. CAPLYTA may cause somnolence, postural hypotension, and motor and/or
   sensory instability, which may lead to falls and, consequently, fractures and
   other injuries. Assess patients for risk when using CAPLYTA.
 * Seizures. Use CAPLYTA cautiously in patients with a history of seizures or
   with conditions that lower seizure threshold.
 * Potential for Cognitive and Motor Impairment. Advise patients to use caution
   when operating machinery or motor vehicles until they know how CAPLYTA
   affects them.
 * Body Temperature Dysregulation. Use CAPLYTA with caution in patients who may
   experience conditions that may increase core body temperature such as
   strenuous exercise, extreme heat, dehydration, or concomitant
   anticholinergics.
 * Dysphagia. Use CAPLYTA with caution in patients at risk for aspiration.

Drug Interactions: Avoid concomitant use with CYP3A4 inducers. Reduce dose for
concomitant use with strong CYP3A4 inhibitors (10.5 mg) or moderate CYP3A4
inhibitors (21 mg).

Special Populations: Neonates exposed to antipsychotic drugs during the third
trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms
following delivery. Breastfeeding is not recommended. Reduce dose for patients
with moderate or severe hepatic impairment (21 mg).

Adverse Reactions: The most common adverse reactions in clinical trials with
CAPLYTA vs placebo were:

 * Schizophrenia: somnolence/sedation (24% vs 10%) and dry mouth (6% vs 2%).
 * Bipolar Depression (Monotherapy, Adjunctive therapy): somnolence/sedation
   (13% vs 3%, 13% vs 3%), dizziness (8% vs 4%, 11% vs 2%), nausea (8% vs 3%, 9%
   vs 4%), and dry mouth (5% vs 1%, 5% vs 1%).

CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

Please see full Prescribing Information, including Boxed Warnings.

Click here for WAC disclosure and pricing transparency.

References: 1. Bipolar disorder. National Institute of Mental Health. Accessed
June 17, 2022. https://www.nimh.nih.gov/health/statistics/bipolar-disorder.html
2. State population by characteristics: 2010-2020. United States Census Bureau.
July 2020. Accessed June 17, 2022.
https://www.census.gov/programs-surveys/popest/technical-documentation/research/evaluation-estimates/
2020-evaluation-estimates/2010s-state-detail.html 3. Forte A, Baldessarini RJ,
Tondo L, et al. Long-term morbidity in bipolar-I, bipolar-II, and unipolar major
depressive disorders. J Affect Disord. 2015;178:71-78. 4. CAPLYTA prescribing
information. Intra-cellular Therapies; 2022.

CAPLYTA is a registered trademark of Intra-Cellular Therapies, Inc.
All other trademarks and registered trademarks are property of their respective
owners.
© 2023 Intra-Cellular Therapies, Inc. All rights reserved. US-CAP-2300215  04/23

The site is published by ConneXion360, LLC, and is intended for healthcare
professionals in the United States only.

Your use of information on the site and your registration for services and
events offered through this site are subject to the ConneXion360 Terms of Use
and its Privacy Policy.

Do Not Sell My Personal Information | ­1-877-238-8500­

×
Featured Faculty Biography
Rakesh Jain, MD, MPH

Clinical Professor, Department of Psychiatry
Texas Tech University Health Sciences Center

School of Medicine, Permian Basin

Midland, Texas
Physician in Private Practice
Austin, Texas

Rakesh Jain, MD, is a clinical professor of psychiatry at Texas Tech University
School of Medicine and an investigator with Tekton Research Center, both in
Austin. Dr Jain earned his medical degree from the University of Calcutta in
India and his master of public health degree at the University of Texas School
of Public Health in Houston. He completed his residency in psychiatry and
fellowship in child and adolescent psychiatry at the University of Texas Medical
School in Houston. Dr Jain is very involved in continuing medical education
content development and presentation and has been a principal investigator for
more than 80 clinical trials in ADHD, anxiety disorders, major depressive
disorder, panic disorder, and fibromyalgia, studying the effects of medications
on short-term and long-term treatment of depression, anxiety, pain/mood overlap
disorders, and psychosis in adult and child/adolescent populations. Dr Jain is a
member of the Texas Medical Association.




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