Caplyta

— THERAPEUTIC CATEGORIES —
  • Mood disorders
  • Psychosis
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Caplyta Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Lumateperone 10.5mg, 21mg, 42mg; caps.

    Pharmacological Class

    Atypical antipsychotic.

    How Supplied

    Caps—30

    How Supplied

    Capsules

    • 42mg: Blue cap with white body imprinted with “ITI-007 42 mg”—30
    • 21 mg: White cap and body imprinted with “ITI-007 21 mg”—30
    • 10.5 mg: Light pink cap and body imprinted with “ITI-007 10.5 mg”—30

    Storage

    Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

    Manufacturer

    Intra-Cellular Therapies

    Generic Availability

    NO

    Mechanism of Action

    The efficacy of lumateperone could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

     

    Caplyta Indications

    Indications

    Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate.

    Caplyta Dosage and Administration

    Adult

    42mg once daily. Moderate to severe hepatic impairment, or concomitant with moderate CYP3A4 inhibitors: reduce dose to 21mg once daily. Concomitant strong CYP3A4 inhibitors: reduce dose to 10.5mg once daily.

    Children

    Not established.

    Hepatic Impairment

    Moderate to severe hepatic impairment: 21mg once daily.

    Other Modifications

    Coadministration with strong CYP3A4 inhibitors: 10.5mg once daily.

    Coadministration with moderate CYP3A4 inhibitors: 21mg once daily.

    Administration

    May be taken with or without food.

    Dose titration is not required.

    Caplyta Contraindications

    Not Applicable

    Caplyta Boxed Warnings

    Boxed Warning

    Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors.

    Caplyta Warnings/Precautions

    Warnings/Precautions

    Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in all patients. Discontinue immediately if neuroleptic malignant syndrome is suspected. Cardio- or cerebrovascular disease. Risk for hypotension, aspiration, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBC or ANC, or a history of leukopenia/neutropenia; monitor CBC during 1st few months of treatment; consider discontinuing at 1st sign of significant decline in WBC occurs in absence of other causative factors. Exposure to extreme heat. Dehydration. Hypovolemia. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Reevaluate periodically. Write ℞ for smallest practical amount. Moderate to severe hepatic impairment: reduce dose (see Adult). Neonates: risk for extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

    Warnings/Precautions

    Increased Mortality, Cerebrovascular Adverse Reactions (Including Stroke) in Elderly Patients with Dementia-Related Psychosis

    • Caplyta is not approved for the treatment of dementia-related psychosis
    • Antipsychotic use for dementia-related psychosis increases the risk of death in elderly patients, based on analyses from 17 placebo-controlled trials.
    • Other antipsychotics (eg, risperidone, aripiprazole, olanzapine) linked to higher incidence of stroke and transient ischemic attack, including fatal stroke.

    Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults

    • Pooled analyses of placebo-controlled trials (~77,000 adults and 4500 children): Incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients.
    • Patients on antidepressants should be monitored for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and during dosage changes.
    • Persistently worse depression, suicidal thoughts or behaviors: Consider changing regimen or possibly discontinuing treatment.

    Neuroleptic Malignant Syndrome (NMS)

    • Antipsychotic medications have been associated with NMS, a potentially fatal symptom complex.
    • Clinical manifestations of NMS: Hyperpyrexia, muscle rigidity, delirium, autonomic instability.
    • Additional signs of NMS: Elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), acute renal failure.
    • Discontinue Caplyta immediately if NMS is suspected.
    • Intensive symptomatic treatment and monitoring should be provided to patients who develop NMS.

    Tardive Dyskinesia

    • Patients treated with antipsychotics may develop tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements.
    • Risk highest among elderly, especially elderly women.
    • Tardive dyskinesia may develop after a brief treatment period, even at low doses, and may also occur after discontinuation of treatment.
    • Prescribe Caplyta in a manner that reduces the risk of tardive dyskinesia.
    • Reserve chronic antipsychotic treatment for patients who suffer from chronic illness that is known to respond to antipsychotic drugs; and for whom alternative, effective, but potentially less harmful treatments are not available or appropriate.
    • Use the lowest effective dose and the shortest duration of treatment to produce a satisfactory clinical response.
    • Reassess the need for continued treatment and if signs/symptoms of tardive dyskinesia appear, consider discontinuing treatment with Caplyta.
    • Some patients may require continued treatment despite the presence of tardive dyskinesia.

    Metabolic Changes

    • Hyperglycemia and Diabetes Mellitus
      • There have been reports of hyperglycemia in patients treated with Caplyta.
      • Assess fasting plasma glucose before or soon after initiation of Caplyta and monitor periodically during long term treatment.
    • Dyslipidemia
      • Antipsychotics may cause adverse alterations in lipids.
      • Obtain fasting lipid profile at baseline and monitor periodically during treatment.
    • Weight Gain
      • Antipsychotic use has been associated with weight gain.
      • Monitor weight at baseline and frequently thereafter.

    Leukopenia, Neutropenia, and Agranulocytosis

    • Leukopenia and neutropenia have been reported with Caplyta.
    • Risk factors for leukopenia, neutropenia: Pre-existing low white blood cell (WBC) count or absolute neutrophil count (ANC) and history of drug-induced leukopenia or neutropenia; perform CBC in these patients frequently during the first few months of treatment.
    • Consider discontinuing Caplyta at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
    • Monitor patients with clinically significant neutropenia for fever, signs of infection; treat promptly.
    • ANC< 1000/mm3: Discontinue Caplyta.

    Orthostatic Hypotension and Syncope

    • Risk for orthostatic hypotension and syncope is greatest during initial dose administration.
    • Patients vulnerable to hypotension: Orthostatic vital signs should be monitored.
    • Caplyta has not been evaluated in patients with a recent history of myocardial infarction or unstable cardiovascular disease.

    Falls

    • Caplyta may cause somnolence, postural hypotension, and motor and sensory instability.
    • Patients with diseases, conditions or on medications that exacerbate these effects: Complete fall risk assessments when initiating treatment and periodically during long term treatment.

    Seizures

    • Caplyta may cause seizures.
    • The risk is greatest in patients with a history of seizures or with conditions that lower the seizure threshold.

    Potential for Cognitive and Motor Impairment

    • Caplyta may impair judgement, thinking and motor skills.
    • Caution patients not to operate hazardous machinery, including motor vehicles, until they are reasonably certain that therapy does not affect them adversely.

    Body Temperature Dysregulation

    • Atypical antipsychotics may disrupt the body’s ability to reduce core body temperature.
    • Use Caplyta with caution in patients who perform strenuous exercise, are exposed to extreme heat, are dehydrated, or are on anticholinergic medications.

    Dysphagia

    • Esophageal dysmotility and aspiration have been associated with antipsychotic drugs.
    • Use cautiously in patients at risk for aspiration.

    Pregnancy Considerations

    Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

    Health care providers are encouraged to register patients in the National Pregnancy Registry for Atypical Antipsychotics at 866-961-2388 or online at https://womensmentalhealth.org/research/pregnancyregistry/.

    Nursing Mother Considerations

    Lumateperone and its metabolites are present in human breast milk in low amounts, based on a clinical lactation study. However, there are no data on the effects of lumateperone on the breastfed infant or the effects on milk production.

    The benefits of breastfeeding should be considered along with the mother’s clinical need for Caplyta treatment and any potential adverse effects on the breastfed child from Caplyta or from the underlying maternal condition.

    Pediatric Considerations

    Safety and effectiveness of Caplyta have not been established in pediatric patients. Antidepressants have been found to increase the risk of suicidal thoughts/behaviors in pediatric patients.

    Geriatric Considerations

    The number of patients 65 years and older in studies evaluating Caplyta for bipolar disorder was not sufficient to determine whether the response was different from younger patients.

    Caplyta is not approved to treat dementia-related psychosis; antipsychotic drugs increase the risk of death in elderly patients with dementia-related psychosis.

    Hepatic Impairment Considerations

    Dosage reduction is recommended for patients with moderate to severe hepatic impairment as these patients generally had higher exposure to lumateperone than those with normal hepatic function. 

    Other Considerations for Specific Populations

    Lumateperone may impair male and female fertility (based on findings from animal studies).

    Caplyta Pharmacokinetics

    Absorption

    Cmax of lumateperone is reached approximately 1–2 hours after dosing.

    Distribution

    Protein binding of lumateperone: 97.4%.

    Metabolism

    Lumateperone is extensively metabolized. Uridine 5'- diphospho-glucuronosyltransferases (UDP-glucuronosyltransferase, UGT) 1A1, 1A4, and 2B15, aldoketoreductase (AKR)1C1, 1B10, and 1C4, and cytochrome P450 (CYP) 3A4, 2C8, and 1A2, are involved in the metabolism of lumateperone.

    Elimination

    Renal (58%), fecal (29%). Terminal half-life is ~18 hours. 

     

    Caplyta Interactions

    Interactions

    Potentiated by moderate or strong CYP3A4 inhibitors (eg, diltiazem, itraconazole); reduce dose (see Adult). Antagonized by CYP3A4 inducers (eg, rifampin); avoid. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).

    Caplyta Adverse Reactions

    Adverse Reactions

    Somnolence/sedation, dry mouth, dizziness, nausea; tardive dyskinesia (consider discontinuation if occurs), neutropenia, orthostatic hypotension, syncope.

    Caplyta Clinical Trials

    Clinical Trials

    The approval was supported by data from 2 global randomized, double-blind, placebo-controlled phase 3 studies (Study 404 [ClinicalTrials.gov: NCT03249376] and 402 [ClinicalTrials.gov: NCT02600507]) that evaluated the efficacy and safety of Caplyta as monotherapy and adjunctive therapy with lithium or valproate, respectively, in adults with bipolar depression. 

    In Study 404, 381 patients were randomly assigned 1:1 to receive Caplyta 42mg orally once daily or placebo; Study 402 included 529 patients who were randomly assigned 1:1:1 to receive Caplyta 42mg, 28mg, or placebo. 

    The primary endpoint for both studies was the improvement in depression from baseline to week 6, as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). A key secondary end point included the Clinical Global Impression Scale for Bipolar for Severity of Illness-Depression subscale (CGI-BP-S).

    Results from Study 404 showed that Caplyta was associated with a statistically significant improvement on the MADRS total score, with a mean reduction of 16.7 points compared with 12.1 points for placebo, (least squares [LS] mean difference, -4.6 points [95% CI, -6.3, -2.8]; P <.001). Additionally, Caplyta treatment led to statistically significant improvements on the CGI-BP-S depression score.

    In Study 402, Caplyta 42mg was associated with a statistically significant improvement on the MADRS total score, with a mean reduction of 16.9 points compared with 14.5 points for placebo (LS mean difference, -2.4 points [95% CI, -4.4, -0.4]; P =.0206). Caplyta 42mg also met the key secondary end point of statistically significant improvement on the CGI-BP-S depression score. The treatment effect in the Caplyta 28mg group (vs placebo) was not statistically significant.

    Caplyta Note

    Notes

    Register patients in the National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

    Caplyta Patient Counseling

    Patient Counseling

    Monitor for the emergence of suicidality, especially early during treatment; report these symptoms.

    Neuroleptic malignant syndrome has been reported with antipsychotic drugs. Contact a health care provider or report to the emergency room if signs and symptoms of NMS develop.

    Tardive dyskinesia possible with antipsychotic medications; report abnormal movements.

    Risk of metabolic changes, monitoring of blood glucose, lipids, and weight is necessary.

    Pre-existing low WBC or a history of drug induced leukopenia/ neutropenia: CBC monitoring needed during treatment.

    Risk of orthostatic hypotension and syncope, especially early in treatment, and also at times of re-initiating treatment.

    Do not perform activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until it has been established that Caplyta does not not impact cognitive and motor performance adversely.

    Avoid overheating and dehydration.

    Changes in prescription medications, OTC/herbal use should be reported because of potential drug interactions.

    Report pregnancy; use of Caplyta during the third trimester may cause extrapyramidal and/or withdrawal symptoms in the neonate.

    Consider benefits of breastfeeding and any potential adverse effects on the breastfed child during treatment with lumateperone.

    Caplyta may impair fertility.

    Cost Savings Program

    Caplyta Savings Card

    Caplyta Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Lumateperone 10.5mg, 21mg, 42mg; caps.

    Pharmacological Class

    Atypical antipsychotic.

    How Supplied

    Caps—30

    How Supplied

    Capsules

    • 42mg: Blue cap with white body imprinted with “ITI-007 42 mg”—30
    • 21 mg: White cap and body imprinted with “ITI-007 21 mg”—30
    • 10.5 mg: Light pink cap and body imprinted with “ITI-007 10.5 mg”—30

    Storage

    Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

    Manufacturer

    Intra-Cellular Therapies

    Generic Availability

    NO

    Mechanism of Action

    The efficacy of lumateperone could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

     

    Caplyta Indications

    Indications

    Schizophrenia.

    Caplyta Dosage and Administration

    Adult

    42mg once daily. Moderate to severe hepatic impairment, or concomitant with moderate CYP3A4 inhibitors: reduce dose to 21mg once daily. Concomitant strong CYP3A4 inhibitors: reduce dose to 10.5mg once daily.

    Children

    Not established.

    Hepatic Impairment

    Moderate to severe hepatic impairment: 21mg once daily.

    Other Modifications

    Coadministration with strong CYP3A4 inhibitors: 10.5mg once daily.

    Coadministration with moderate CYP3A4 inhibitors: 21mg once daily.

    Administration

    May be taken with or without food.

    Dose titration is not required.

    Caplyta Contraindications

    Not Applicable

    Caplyta Boxed Warnings

    Boxed Warning

    Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors.

    Caplyta Warnings/Precautions

    Warnings/Precautions

    Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in all patients. Discontinue immediately if neuroleptic malignant syndrome is suspected. Cardio- or cerebrovascular disease. Risk for hypotension, aspiration, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBC or ANC, or a history of leukopenia/neutropenia; monitor CBC during 1st few months of treatment; consider discontinuing at 1st sign of significant decline in WBC occurs in absence of other causative factors. Exposure to extreme heat. Dehydration. Hypovolemia. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Reevaluate periodically. Write ℞ for smallest practical amount. Moderate to severe hepatic impairment: reduce dose (see Adult). Neonates: risk for extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

    Warnings/Precautions

    Increased Mortality, Cerebrovascular Adverse Reactions (Including Stroke) in Elderly Patients with Dementia-Related Psychosis

    • Caplyta is not approved for the treatment of dementia-related psychosis
    • Antipsychotic use for dementia-related psychosis increases the risk of death in elderly patients, based on analyses from 17 placebo-controlled trials.
    • Other antipsychotics (eg, risperidone, aripiprazole, olanzapine) linked to higher incidence of stroke and transient ischemic attack, including fatal stroke.

    Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults

    • Pooled analyses of placebo-controlled trials (~77,000 adults and 4500 children): Incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients.
    • Patients on antidepressants should be monitored for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and during dosage changes.
    • Persistently worse depression, suicidal thoughts or behaviors: Consider changing regimen or possibly discontinuing treatment.

    Neuroleptic Malignant Syndrome (NMS)

    • Antipsychotic medications have been associated with NMS, a potentially fatal symptom complex.
    • Clinical manifestations of NMS: Hyperpyrexia, muscle rigidity, delirium, autonomic instability.
    • Additional signs of NMS: Elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), acute renal failure.
    • Discontinue Caplyta immediately if NMS is suspected.
    • Intensive symptomatic treatment and monitoring should be provided to patients who develop NMS.

    Tardive Dyskinesia

    • Patients treated with antipsychotics may develop tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements.
    • Risk highest among elderly, especially elderly women.
    • Tardive dyskinesia may develop after a brief treatment period, even at low doses, and may also occur after discontinuation of treatment.
    • Prescribe Caplyta in a manner that reduces the risk of tardive dyskinesia.
    • Reserve chronic antipsychotic treatment for patients who suffer from chronic illness that is known to respond to antipsychotic drugs; and for whom alternative, effective, but potentially less harmful treatments are not available or appropriate.
    • Use the lowest effective dose and the shortest duration of treatment to produce a satisfactory clinical response.
    • Reassess the need for continued treatment and if signs/symptoms of tardive dyskinesia appear, consider discontinuing treatment with Caplyta.
    • Some patients may require continued treatment despite the presence of tardive dyskinesia.

    Metabolic Changes

    • Hyperglycemia and Diabetes Mellitus
      • There have been reports of hyperglycemia in patients treated with Caplyta.
      • Assess fasting plasma glucose before or soon after initiation of Caplyta and monitor periodically during long term treatment.
    • Dyslipidemia
      • Antipsychotics may cause adverse alterations in lipids.
      • Obtain fasting lipid profile at baseline and monitor periodically during treatment.
    • Weight Gain
      • Antipsychotic use has been associated with weight gain.
      • Monitor weight at baseline and frequently thereafter.

    Leukopenia, Neutropenia, and Agranulocytosis

    • Leukopenia and neutropenia have been reported with Caplyta.
    • Risk factors for leukopenia, neutropenia: Pre-existing low white blood cell (WBC) count or absolute neutrophil count (ANC) and history of drug-induced leukopenia or neutropenia; perform CBC in these patients frequently during the first few months of treatment.
    • Consider discontinuing Caplyta at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
    • Monitor patients with clinically significant neutropenia for fever, signs of infection; treat promptly.
    • ANC< 1000/mm3: Discontinue Caplyta.

    Orthostatic Hypotension and Syncope

    • Risk for orthostatic hypotension and syncope is greatest during initial dose administration.
    • Patients vulnerable to hypotension: Orthostatic vital signs should be monitored.
    • Caplyta has not been evaluated in patients with a recent history of myocardial infarction or unstable cardiovascular disease.

    Falls

    • Caplyta may cause somnolence, postural hypotension, and motor and sensory instability.
    • Patients with diseases, conditions or on medications that exacerbate these effects: Complete fall risk assessments when initiating treatment and periodically during long term treatment.

    Seizures

    • Caplyta may cause seizures.
    • The risk is greatest in patients with a history of seizures or with conditions that lower the seizure threshold.

    Potential for Cognitive and Motor Impairment

    • Caplyta may impair judgement, thinking and motor skills.
    • Caution patients not to operate hazardous machinery, including motor vehicles, until they are reasonably certain that therapy does not affect them adversely.

    Body Temperature Dysregulation

    • Atypical antipsychotics may disrupt the body’s ability to reduce core body temperature.
    • Use Caplyta with caution in patients who perform strenuous exercise, are exposed to extreme heat, are dehydrated, or are on anticholinergic medications.

    Dysphagia

    • Esophageal dysmotility and aspiration have been associated with antipsychotic drugs.
    • Use cautiously in patients at risk for aspiration.

    Pregnancy Considerations

    Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

    Health care providers are encouraged to register patients in the National Pregnancy Registry for Atypical Antipsychotics at 866-961-2388 or online at https://womensmentalhealth.org/research/pregnancyregistry/.

    Nursing Mother Considerations

    Lumateperone and its metabolites are present in human breast milk in low amounts, based on a clinical lactation study. However, there are no data on the effects of lumateperone on the breastfed infant or the effects on milk production.

    The benefits of breastfeeding should be considered along with the mother’s clinical need for Caplyta treatment and any potential adverse effects on the breastfed child from Caplyta or from the underlying maternal condition.

    Pediatric Considerations

    Safety and effectiveness of Caplyta have not been established in pediatric patients. Antidepressants have been found to increase the risk of suicidal thoughts/behaviors in pediatric patients.

    Geriatric Considerations

    Schizophrenia trials did not include patients aged 65 years and older to determine whether or not they respond differently from younger patients.

    Caplyta is not approved to treat dementia-related psychosis; antipsychotic drugs increase the risk of death in elderly patients with dementia-related psychosis.

    Hepatic Impairment Considerations

    Dosage reduction is recommended for patients with moderate to severe hepatic impairment as these patients generally had higher exposure to lumateperone than those with normal hepatic function. 

    Other Considerations for Specific Populations

    Lumateperone may impair male and female fertility (based on findings from animal studies).

    Caplyta Pharmacokinetics

    Absorption

    Cmax of lumateperone is reached approximately 1–2 hours after dosing.

    Distribution

    Protein binding of lumateperone: 97.4%.

    Metabolism

    Lumateperone is extensively metabolized. Uridine 5'- diphospho-glucuronosyltransferases (UDP-glucuronosyltransferase, UGT) 1A1, 1A4, and 2B15, aldoketoreductase (AKR)1C1, 1B10, and 1C4, and cytochrome P450 (CYP) 3A4, 2C8, and 1A2, are involved in the metabolism of lumateperone.

    Elimination

    Renal (58%), fecal (29%). Terminal half-life is ~18 hours. 

     

    Caplyta Interactions

    Interactions

    Potentiated by moderate or strong CYP3A4 inhibitors (eg, diltiazem, itraconazole); reduce dose (see Adult). Antagonized by CYP3A4 inducers (eg, rifampin); avoid. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).

    Caplyta Adverse Reactions

    Adverse Reactions

    Somnolence/sedation, dry mouth, dizziness, nausea; tardive dyskinesia (consider discontinuation if occurs), neutropenia, orthostatic hypotension, syncope.

    Caplyta Clinical Trials

    Clinical Trials

    Approval was based on results from 2 double-blind, placebo-controlled trials (Study 1:  ClinicalTrials.gov Identifier: NCT01499563 [N=335] and Study 2: ClinicalTrials.gov Identifier: NCT02282761 [N=450]), which evaluated the efficacy of Caplyta in patients with schizophrenia for 28 days. 

    Study 1: Median age was 42 years (range 20 to 55 years). 17% were female, 19% were Caucasian, and 78% were African American.

    Study 2: Median age was 44 years (range 19 to 60 years); 23% were female, 26% were Caucasian and 66% were African American.

    Primary endpoint: Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at week 4. The PANSS is a 30-item scale used to measure symptoms of schizophrenia. Each item is rated by a clinician on a 7-point scale. A score of 1 indicates the absence of symptoms, and a score of 7 indicates extremely severe symptoms. The PANSS total score may range from 30 to 210 with higher scores reflecting greater overall symptom severity.

    Findings from Study 1 and Study 2 showed that Caplyta 42mg once daily demonstrated a statistically significant reduction from baseline to day 28 in the PANSS total score with a placebo-subtracted difference of -5.8 (95% CI, -10.5, -1.1) and -4.2 (95% CI, -7.8, -0.6), respectively.

    Studies 1 and 2 did not include any patients aged 65 or older.

    Caplyta Note

    Notes

    Register patients in the National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

    Caplyta Patient Counseling

    Patient Counseling

    Monitor for the emergence of suicidality, especially early during treatment; report these symptoms.

    Neuroleptic malignant syndrome has been reported with antipsychotic drugs. Contact a health care provider or report to the emergency room if signs and symptoms of NMS develop.

    Tardive dyskinesia possible with antipsychotic medications; report abnormal movements.

    Risk of metabolic changes, monitoring of blood glucose, lipids, and weight is necessary.

    Pre-existing low WBC or a history of drug induced leukopenia/ neutropenia: CBC monitoring needed during treatment.

    Risk of orthostatic hypotension and syncope, especially early in treatment, and also at times of re-initiating treatment.

    Do not perform activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until it has been established that Caplyta does not not impact cognitive and motor performance adversely.

    Avoid overheating and dehydration.

    Changes in prescription medications, OTC/herbal use should be reported because of potential drug interactions.

    Report pregnancy; use of Caplyta during the third trimester may cause extrapyramidal and/or withdrawal symptoms in the neonate.

    Consider benefits of breastfeeding and any potential adverse effects on the breastfed child during treatment with lumateperone.

    Caplyta may impair fertility.

    Cost Savings Program

    Caplyta Savings Card

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