Latuda

— THERAPEUTIC DISORDERS TREATED —
  • 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

    • Latuda Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Lurasidone HCl 20mg, 40mg, 60mg, 80mg, 120mg; tabs.

    Pharmacological Class

    Atypical antipsychotic.

    How Supplied

    Tabs—30, 90, 500

    How Supplied

    Latuda 20mg 

    • White to off-white, round tablet; marked with “L20” one-sided debossing; supplied in 30-, 90-, 500-count bottles, and a box of 100 Hospital Unit Dose (10 blister cards, 10 tablets each).

    Latuda 40mg 

    • White to off-white, round tablet; marked with “L40” one-sided debossing; supplied in 30-, 90-, 500-count bottles, and a box of 100 Hospital Unit Dose (10 blister cards, 10 tablets each).

    Latuda 60mg 

    • White to off-white, oblong tablets; marked with “L60” one-sided debossing; supplied in 30-, 90-, 500-count bottles, and a box of 100 Hospital Unit Dose (10 blister cards, 10 tablets each).

    Latuda 80mg 

    • Pale green, oval tablets; marked with “L80” one-sided debossing; and supplied in 30-, 90-, 500-count bottles, and a box of 100 Hospital Unit Dose (10 blister cards, 10 tablets each).

    Latuda 120mg 

    • White to off-white, oval tablets; marked with “L120” one-sided debossing; and supplied in 30-, 90-, 500-count bottles, and a box of 100 Hospital Unit Dose (10 blister cards, 10 tablets each).

    Storage

    Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F).

    Manufacturer

    Sunovion

    Mechanism of Action

    The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D2 and serotonin Type 2 (5HT2A) receptor antagonism.

    Latuda Indications

    Indications

    Major depressive episodes associated with bipolar I disorder as monotherapy in patients ≥10yrs and as adjunctive therapy with lithium or valproate in adults.

    Latuda Dosage and Administration

    Adult

    Take with food (≥350 calories). Initially 20mg once daily. Usual range: 20–120mg/day; max 120mg/day. Moderate (CrCl 30 to <50mL/min) to severe renal impairment (CrCl <30mL/min), moderate hepatic impairment (Child Pugh Score 7–9): initially 20mg; max 80mg/day. Severe hepatic impairment (Child Pugh Score 10–15): initially 20mg; max 40mg/day. If moderate CYP3A4 inhibitors (eg, diltiazem, atazanavir, erythromycin, fluconazole, verapamil) is added concomitant to prescribed lurasidone therapy: reduce lurasidone dose to ½ of the original dose; if lurasidone is added concomitant to prescribed moderate CYP3A4 inhibitors: initially 20mg/day; max 80mg/day. Concomitant moderate CYP3A4 inducers (eg, bosentan, efavirenz, etravirine, modafinil, nafcillin): may need to increase lurasidone dose after chronic treatment (≥7 days) with inducer.

    Children

    <10yrs: not established. Take with food (≥350 calories). 10–17yrs: initially 20mg once daily as monotherapy; may increase after 1 week based on response. Usual range: 20–80mg/day; max 80mg/day.

    Renal Impairment

    Dosage reduction is recommended for patients with moderate or severe renal impairment (CLcr<50 mL/minute). Patients with impaired renal function (CLcr<50 mL/minute) had higher exposure to lurasidone than patients with normal renal function. Greater exposure may increase the risk of Latuda-associated adverse reactions. 

    Hepatic Impairment

    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. 

    Latuda Contraindications

    Contraindications

    Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil) and inducers (eg, rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine).

    Latuda Boxed Warnings

    Boxed Warning

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

    Boxed Warning

    Increased Mortality in Elderly Patients with Dementia-Related Psychosis 

    • Latuda is not approved for the treatment of patients with dementia-related psychosis.

    Suicidal Thoughts and Behaviors 

    • Increased risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies.

    • Monitor all patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.

     

    Latuda 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 for clinical worsening or behavior changes in all patients. Discontinue if neuroleptic malignant syndrome occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Hypovolemia. Dehydration. Diabetes risk factors; obtain baseline fasting blood sugar. Monitor for hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Moderate to severe hepatic or renal impairment. History of seizures. Mania or hypomania (monitor). Dysphagia. Parkinson's disease. Dementia with Lewy Bodies. Exposure to extreme heat. Perform fall risk assessments when initiating and recurrently on long-term therapy. Write ℞ for smallest practical amount. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Increased Mortality in Elderly Patients with Dementia-Related Psychosis

    • Increased risk of death in elderly patients. 

    • While the causes of death varied, most of the deaths were reported to be cardiovascular or infectious in nature.

    • Latuda is not approved to treat patients with dementia-related psychosis.

    Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients

    • Unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adults extends to longer-term use (eg, beyond 4 months).

    • Monitor all patients for clinical worsening and emergence of suicidal thoughts and behaviors (esp during the initial few months of treatment and at times of dosage changes).

    • Changes in behavior should be monitored by family members or caregivers.

    • If depression persistently worsens or if emergent suicidal thoughts or behaviors develop, consider changing treatment regimen, including potentially discontinuing Latuda.

    Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis

    • Latuda is not approved to treat patients with dementia-related psychosis.

    Neuroleptic Malignant Syndrome (NMS)

    • Discontinue immediately if NMS is suspected and administer intensive symptomatic treatment and monitoring.

    • NMS is associated with the following clinical manifestations: hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. 

    Tardive Dyskinesia  

    • The risk of developing tardive dyskinesia and the likelihood it becomes irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase.

    • Signs and symptoms of tardive dyskinesia may be suppressed by Antipsychotic treatment and may possibly mask the underlying process. The effects that symptomatic suppression has on the long-term course of the syndrome is unknown.  Prescribe Latuda in order to minimize the occurrence of tardive dyskinesia.

    • Reserve chronic antipsychotic treatment for patients with chronic illness that:

      • Is known to respond to antipsychotic drugs, and for whom alternative, equally effective but potentially less harmful treatments are unavailable or inappropriate.

      • Patients who require chronic treatment should be given the smallest dose and the shortest duration of treatment and be reassessed periodically.

    • Consider discontinuing Latuda if tardive dyskinesia develops.

    Metabolic Changes  

    • Have been associated with metabolic changes (eg, hyperglycemia, dyslipidemia, and body weight gain) that may increase cardiovascular/cerebrovascular risk.

    • Hyperglycemia and Diabetes Mellitus

      • There have been reports of hyperglycemia in patients treated with Latuda.

      • Assess fasting plasma glucose before or soon after initiation of Latuda 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.

    Hyperprolactinemia

    • Latuda may elevate prolactin levels.

    • Long-standing hyperprolactinemia, when associated with hypogonadism, may result in decreased bone density.

    Leukopenia, Neutropenia and Agranulocytosis  

    • Leukopenia and neutropenia have been reported with antipsychotic agents.

    • 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.

    • Discontinue Latuda at the first sign of 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 Latuda and have the patient's WBC followed until recovery.

    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, and consider using a lower starting dose of Laturda and slower titration.

    Falls

    • Latuda 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

    • Latuda may cause seizures.

    • The risk is greatest in patients with a history of seizures or with conditions that lower the seizure threshold (eg, Alzheimer dementia, elderly >65yrs).

    Potential for Cognitive and Motor Impairment

    • Latuda 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 Latuda with caution in patients who perform strenuous exercise, are exposed to extreme heat, are dehydrated, or are on anticholinergic medications.

    Activation of Mania/Hypomania 

    • Increased risk of developing a manic or hypomanic episode (esp in patients with bipolar disorder).

    • Monitor for emergence of such episodes.

    Dysphagia

    • Esophageal dysmotility and aspiration have been associated with antipsychotic drugs.

    • Use cautiously in patients at risk for aspiration pneumonia.

    Pregnancy Considerations

    Risk Summary

    • Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There are no studies of Latuda use in pregnant women.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: Neonates who were exposed to antipsychotic drugs during the 3rd trimester of pregnancy have been reported to present with extrapyramidal and/or withdrawal symptoms. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately.  

    Nursing Mother Considerations

    Risk Summary

    • Consider the development and health benefits of breastfeeding along with the mother’s clinical need for Latuda and any potential adverse effects on the breastfed infant from Latuda or from the underlying maternal condition.

    Pediatric Considerations

    Schizophrenia

    • Safety and effectiveness of Latuda have not been established in pediatric patients less than 13 years of age with schizophrenia. 

    Bipolar Depression

    • Safety and effectiveness of Latuda have not been established in pediatric patients less than 10 years of age with bipolar depression.

    Geriatric Considerations

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

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

    Renal Impairment Considerations

    Dosage reduction is recommended for patients with moderate or severe renal impairment (CLcr<50 mL/minute). Patients with impaired renal function (CLcr<50 mL/minute) had higher exposure to lurasidone than patients with normal renal function. Greater exposure may increase the risk of Latuda-associated adverse reactions. 

    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. 

    Latuda Pharmacokinetics

    Absorption

    • Peak serum concentrations: approximately 1 to 3 hours.

    • Approximately 9 to 19% of an administered dose is absorbed.

    Distribution

    • Mean apparent volume of distribution: 6173 (17.2) L.

    • Highly bound (~99%) to serum proteins.

    Metabolism

    • CYP3A4.

    Elimination

    • Half-life: 18 hours.

    • Fecal (80%), renal (9%).

    Latuda Interactions

    Interactions

    See Adults and Contraindications. Avoid grapefruit and grapefruit juice.

    Latuda Adverse Reactions

    Adverse Reactions

    Somnolence, akathisia, extrapyramidal symptoms, nausea, rhinitis/rhinorrhea (80mg), vomiting, weight gain, insomnia; orthostatic hypotension and syncope possible.

    Latuda Clinical Trials

    Clinical Trials

    Adults (Monotherapy)

    • Approval was based on a 6-week, multicenter, randomized, double-blind, placebo-controlled study of adult patients (mean age of 41.5 years, range 18 to 74) with major depressive episodes associated with bipolar I disorder, with or without rapid cycling, and without psychotic features (N=485).

    • Patients were randomized to receive one of two flexible-dose ranges of Latuda (20 to 60mg/day, or 80 to 120mg/day) or placebo.

    • The primary endpoint was the change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score at Week 6. The key secondary endpoint was the Clinical Global Impression-Bipolar-Severity of Illness scale (CGI-BP-S).

    • At week 6, both doses of Latuda achieved superiority to placebo in reduction of MADRS and CGI-BP-S scores. Overall, the high dose range (80 to 120mg/day) did not provide additional benefit compared with the low dose range (20 to 60mg/day).

    Adults (Adjunctive Therapy with Lithium or Valproate)

    • Approval was based on a  6-week, multicenter, randomized, double-blind, placebo-controlled study of adult patients (mean age of 41.7 years, range 18 to 72)  with major depressive episodes associated with bipolar I disorder, with or without rapid cycling, and without psychotic features (N=340). Patients who remained symptomatic after treatment with lithium or valproate were randomized to flexibly dosed Latuda 20 to 120 mg/day or placebo.  

    • The primary endpoint was the change from baseline in MADRS score at Week 6. The key secondary instrument was the CGI-BP-S scale. 

    • At week 6, Latuda was superior to placebo in reduction of MADRS and CGI-BP-S scores as an adjunctive therapy with lithium or valproate.

    Pediatric Patients (10 to 17 years)  

    • Approval was based on a 6-week, multicenter, randomized, double-blind, placebo-controlled study of pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder, with or without rapid cycling, and without psychotic features (N=343). Patients were randomized to flexibly dosed LATUDA 20 to 80 mg/day or placebo.

    • The primary endpoint was the change from baseline in CDRS-R score at Week 6. The key secondary endpoint was the change from baseline in CGIBP-S depression score. 

    • At week 6, Latuda was superior to placebo in reduction of CDRS-R total score and CGI-BP-S depression score.

    Latuda Note

    Not Applicable

    Latuda Patient Counseling

    Cost Savings Program

    Latuda Copay Savings Program

    Latuda Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Lurasidone HCl 20mg, 40mg, 60mg, 80mg, 120mg; tabs.

    Pharmacological Class

    Atypical antipsychotic.

    How Supplied

    Tabs—30, 90, 500

    How Supplied

    Latuda 20mg 

    • White to off-white, round tablet; marked with “L20” one-sided debossing; supplied in 30-, 90-, 500-count bottles, and a box of 100 Hospital Unit Dose (10 blister cards, 10 tablets each).

    Latuda 40mg 

    • White to off-white, round tablet; marked with “L40” one-sided debossing; supplied in 30-, 90-, 500-count bottles, and a box of 100 Hospital Unit Dose (10 blister cards, 10 tablets each).

    Latuda 60mg 

    • White to off-white, oblong tablets; marked with “L60” one-sided debossing; supplied in 30-, 90-, 500-count bottles, and a box of 100 Hospital Unit Dose (10 blister cards, 10 tablets each).

    Latuda 80mg 

    • Pale green, oval tablets; marked with “L80” one-sided debossing; and supplied in 30-, 90-, 500-count bottles, and a box of 100 Hospital Unit Dose (10 blister cards, 10 tablets each).

    Latuda 120mg 

    • White to off-white, oval tablets; marked with “L120” one-sided debossing; and supplied in 30-, 90-, 500-count bottles, and a box of 100 Hospital Unit Dose (10 blister cards, 10 tablets each).

    Storage

    Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F).

    Manufacturer

    Sunovion

    Mechanism of Action

    The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D2 and serotonin Type 2 (5HT2A) receptor antagonism.

    Latuda Indications

    Indications

    Schizophrenia.

    Latuda Dosage and Administration

    Adult

    Take with food (≥350 calories). Initially 40mg once daily. Usual range: 40–160mg/day; max 160mg/day. Moderate (CrCl 30 to <50mL/min) to severe renal impairment (CrCl <30mL/min), moderate hepatic impairment (Child Pugh Score 7–9): initially 20mg; max 80mg/day. Severe hepatic impairment (Child Pugh Score 10–15): initially 20mg; max 40mg/day. If moderate CYP3A4 inhibitors (eg, diltiazem, atazanavir, erythromycin, fluconazole, verapamil) is added concomitant to prescribed lurasidone therapy: reduce lurasidone dose to ½ of the original dose; if lurasidone is added concomitant to prescribed moderate CYP3A4 therapy: initially 20mg/day; max 80mg/day. Concomitant moderate CYP3A4 inducers (eg, bosentan, efavirenz, etravirine, modafinil, nafcillin): may need to increase lurasidone dose after chronic treatment (≥7 days) with inducer.

    Children

    <13yrs: not established. Take with food (≥350 calories). 13–17yrs: initially 40mg once daily. Usual range: 40–80mg/day; max 80mg/day. Dose modifications: see Adult.

    Renal Impairment

    Dosage reduction is recommended for patients with moderate or severe renal impairment (CLcr<50 mL/minute). Patients with impaired renal function (CLcr<50 mL/minute) had higher exposure to lurasidone than patients with normal renal function. Greater exposure may increase the risk of Latuda-associated adverse reactions. 

    Hepatic Impairment

    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. 

    Latuda Contraindications

    Contraindications

    Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil) and inducers (eg, rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine).

    Latuda Boxed Warnings

    Boxed Warning

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

    Boxed Warning

    Increased Mortality in Elderly Patients with Dementia-Related Psychosis 

    • Latuda is not approved for the treatment of patients with dementia-related psychosis.

    Suicidal Thoughts and Behaviors 

    • Increased risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies.

    • Monitor all patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.

     

    Latuda 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 for clinical worsening or behavior changes in all patients. Discontinue if neuroleptic malignant syndrome occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Hypovolemia. Dehydration. Diabetes risk factors; obtain baseline fasting blood sugar. Monitor for hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Moderate to severe hepatic or renal impairment. History of seizures. Mania or hypomania (monitor). Dysphagia. Parkinson's disease. Dementia with Lewy Bodies. Exposure to extreme heat. Perform fall risk assessments when initiating and recurrently on long-term therapy. Write ℞ for smallest practical amount. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Increased Mortality in Elderly Patients with Dementia-Related Psychosis

    • Increased risk of death in elderly patients. 

    • While the causes of death varied, most of the deaths were reported to be cardiovascular or infectious in nature.

    • Latuda is not approved to treat patients with dementia-related psychosis.

    Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients

    • Unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adults extends to longer-term use (eg, beyond 4 months).

    • Monitor all patients for clinical worsening and emergence of suicidal thoughts and behaviors (esp during the initial few months of treatment and at times of dosage changes).

    • Changes in behavior should be monitored by family members or caregivers.

    • If depression persistently worsens or if emergent suicidal thoughts or behaviors develop, consider changing treatment regimen, including potentially discontinuing Latuda.

    Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis

    • Latuda is not approved to treat patients with dementia-related psychosis.

    Neuroleptic Malignant Syndrome (NMS)

    • Discontinue immediately if NMS is suspected and administer intensive symptomatic treatment and monitoring.

    • NMS is associated with the following clinical manifestations: hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. 

    Tardive Dyskinesia  

    • The risk of developing tardive dyskinesia and the likelihood it becomes irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase.

    • Signs and symptoms of tardive dyskinesia may be suppressed by Antipsychotic treatment and may possibly mask the underlying process. The effects that symptomatic suppression has on the long-term course of the syndrome is unknown.  Prescribe Latuda in order to minimize the occurrence of tardive dyskinesia.

    • Reserve chronic antipsychotic treatment for patients with chronic illness that:

      • Is known to respond to antipsychotic drugs, and for whom alternative, equally effective but potentially less harmful treatments are unavailable or inappropriate.

      • Patients who require chronic treatment should be given the smallest dose and the shortest duration of treatment and be reassessed periodically.

    • Consider discontinuing Latuda if tardive dyskinesia develops.

    Metabolic Changes  

    • Have been associated with metabolic changes (eg, hyperglycemia, dyslipidemia, and body weight gain) that may increase cardiovascular/cerebrovascular risk.

    • Hyperglycemia and Diabetes Mellitus

      • There have been reports of hyperglycemia in patients treated with Latuda.

      • Assess fasting plasma glucose before or soon after initiation of Latuda 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.

    Hyperprolactinemia

    • Latuda may elevate prolactin levels.

    • Long-standing hyperprolactinemia, when associated with hypogonadism, may result in decreased bone density.

    Leukopenia, Neutropenia and Agranulocytosis  

    • Leukopenia and neutropenia have been reported with antipsychotic agents.

    • 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.

    • Discontinue Latuda at the first sign of 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 Latuda and have the patient's WBC followed until recovery.

    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, and consider using a lower starting dose of Laturda and slower titration.

    Falls

    • Latuda 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

    • Latuda may cause seizures.

    • The risk is greatest in patients with a history of seizures or with conditions that lower the seizure threshold (eg, Alzheimer dementia, elderly >65yrs).

    Potential for Cognitive and Motor Impairment

    • Latuda 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 Latuda with caution in patients who perform strenuous exercise, are exposed to extreme heat, are dehydrated, or are on anticholinergic medications.

    Activation of Mania/Hypomania 

    • Increased risk of developing a manic or hypomanic episode (esp in patients with bipolar disorder).

    • Monitor for emergence of such episodes.

    Dysphagia

    • Esophageal dysmotility and aspiration have been associated with antipsychotic drugs.

    • Use cautiously in patients at risk for aspiration pneumonia.

    Pregnancy Considerations

    Risk Summary

    • Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There are no studies of Latuda use in pregnant women.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: Neonates who were exposed to antipsychotic drugs during the 3rd trimester of pregnancy have been reported to present with extrapyramidal and/or withdrawal symptoms. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately.  

    Nursing Mother Considerations

    Risk Summary

    • Consider the development and health benefits of breastfeeding along with the mother’s clinical need for Latuda and any potential adverse effects on the breastfed infant from Latuda or from the underlying maternal condition.

    Pediatric Considerations

    Schizophrenia

    • Safety and effectiveness of Latuda have not been established in pediatric patients less than 13 years of age with schizophrenia. 

    Bipolar Depression

    • Safety and effectiveness of Latuda have not been established in pediatric patients less than 10 years of age with bipolar depression.

    Geriatric Considerations

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

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

    Renal Impairment Considerations

    Dosage reduction is recommended for patients with moderate or severe renal impairment (CLcr<50 mL/minute). Patients with impaired renal function (CLcr<50 mL/minute) had higher exposure to lurasidone than patients with normal renal function. Greater exposure may increase the risk of Latuda-associated adverse reactions. 

    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. 

    Latuda Pharmacokinetics

    Absorption

    • Peak serum concentrations: approximately 1 to 3 hours.

    • Approximately 9 to 19% of an administered dose is absorbed.

    Distribution

    • Mean apparent volume of distribution: 6173 (17.2) L.

    • Highly bound (~99%) to serum proteins.

    Metabolism

    • CYP3A4.

    Elimination

    • Half-life: 18 hours.

    • Fecal (80%), renal (9%).

    Latuda Interactions

    Interactions

    See Adults and Contraindications. Avoid grapefruit and grapefruit juice.

    Latuda Adverse Reactions

    Adverse Reactions

    Somnolence, akathisia, extrapyramidal symptoms, nausea, rhinitis/rhinorrhea (80mg), vomiting, weight gain, insomnia; orthostatic hypotension and syncope possible.

    Latuda Clinical Trials

    Clinical Trials

    Adults

    • Approval was based on five 6-week, placebo-controlled studies in adults with schizophrenia. An active-control arm (olanzapine or quetiapine extended-release) was included in 2 studies to assess assay sensitivity.

    • The studies assessed psychiatric signs and symptoms at the end of week 6 by using the following:

      • Positive and Negative Syndrome Scale (PANSS), is a multi-item inventory of general psychopathology used to evaluate the effects of drug treatment in schizophrenia. PANSS total scores may range from 30 to 210. 

      • Brief Psychiatric Rating Scale derived (BPRSd), derived from the PANSS, is a multi-item inventory primarily focusing on positive symptoms of schizophrenia, whereas the PANSS includes a wider range of positive, negative and other symptoms of schizophrenia. The BPRSd consists of 18 items rated on a scale of 1 (not present) to 7 (severe). BPRSd scores may range from 18 to 126.

      • The Clinical Global Impression severity scale (CGI-S) is a clinician-rated scale that measures the subject’s current illness state on a 1- to 7-point scale.

    • At week 6, study results are as followed:

      • Study 1 - Latuda 40mg or 120mg/day achieved superiority to placebo on the BPRSd total score, and the CGI-S.

      • Study 2 - Latuda 80mg/day achieved superiority to placebo on the BPRSd total score, and the CGI-S.

      • Study 3 - Latuda 40mg or 120mg/day achieved superiority to placebo on the PANSS total score, and the CGI-S.

      • Study 4 - Latuda 80mg/day achieved superiority to placebo on the PANSS total score, and the CGI-S.

      • Study 5 - Latuda 80mg or 160mg/day achieved superiority to placebo on the PANSS total score, and the CGI-S.

    Adolescents (13-17 years) 

    • Approval was based on a 6-week, multicenter, randomized, double-blind, placebo-controlled study of 326 adolescents (13 to 17 years) with schizophrenia. Patients were randomized to receive Latuda (40 or 80 mg/day) or placebo.  

    • The primary rating instrument used to assess psychiatric signs and symptoms was the PANSS. The key secondary instrument was the CGI-S.

    • At week 6, both doses of Latuda achieved superiority to placebo in reduction of PANSS and CGI-S scores. Overall, the 80mg/day dose did not provide additional benefit compared with the 40mg/day dose.

    Latuda Note

    Not Applicable

    Latuda Patient Counseling

    Cost Savings Program

    Latuda Copay Savings Program

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