Long-Term Use of Latuda® (lurasidone HCl) | HCP Resources

Dr. Smith's Dashboard

Sunovion Services

Request complimentary samples of LATUDA® (lurasidone HCl) tablets for your patients

ORDER YOUR SAMPLES NOW

Need support? Ask Sunovion Answers for information about LATUDA® (lurasidone HCl)

 

A dedicated team is available 7 days a week, from 8 AM to 12:00 midnight ET, to answer patient's calls at 1-855-552-8832

LEARN MORE

Most Viewed

Adult long-term safety data 

Long-term open-label continuation study

Latuda® (lurasidone HCl) Bipolar Depression - Long-Term Study Design

Latuda® (lurasidone HCl) Bipolar Depression - Long-Term Study Design

 
  • The long-term continuation study was an 18-month open-label study designed to monitor safety, tolerability, and effectiveness of LATUDA 20-80 mg/day in adult patients who were initially enrolled in one of the three 6-week double-blind, placebo-controlled studies (1 monotherapy study and 2 adjunctive therapy studies with lithium or valproate), followed by a 6-month open-label extension study of LATUDA 20-120 mg/day1
  • A total of 1,199 patients entered and 941 (78.5%) completed the initial 6-week double-blind phase, of these patients 817/941 (86.8%) entered and 559 completed the 6-month extension study; 122/559 patients (21.8%) entered the 18-month continuation study, of whom 40/122 (32.8%) completed1
  • Concomitant therapy with mood stabilizers was permitted throughout the open-label extension and continuation studies. The mean dose of LATUDA during the 18-month continuation study was 61.8 mg/day1
  • The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient2

LATUDA had a minimal effect on patients’ weight1

Weight change from double-blind baseline in an adult open-label continuation study

Latuda® (lurasidone HCl) Long-Term Study: Weight Change Seen in Adult Patients with Bipolar Depression Chart

Latuda® (lurasidone HCl) Long-Term Study: Weight Change Seen in Adult Patients with Bipolar Depression Chart

 

Mean weight at baseline of the 6-week, double-blind study (N=122) was 165.9 lb (75.4 kg).1

  • The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient
  • Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended2

*Observed cases.
Year 1 includes 6 months of treatment in the open-label extension study and 6 months of treatment in the open-label continuation study.
Year 2 includes 6 months of treatment in the open-label extension study and 18 months of treatment in the open-label continuation study.


Lipid changes through 2 years

LATUDA had a minimal effect on patients’ lipid parameters

Lipid changes from double-blind baseline in an adult open-label continuation study3*

Latuda® (lurasidone HCl) Long-Term Study: Lipid Changes seen in Adult Patients with Bipolar Depression Chart

Latuda® (lurasidone HCl) Long-Term Study: Lipid Changes seen in Adult Patients with Bipolar Depression Chart

 

Mean lipid parameters at baseline of the 6-week, double-blind study (N=122) were: total cholesterol: 195.5 mg/dL, LDL: 116.8 mg/dL, HDL: 50.5 mg/dL, triglycerides: 151.5 mg/dL.1

  • The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient2
  • Undesirable alterations in lipids have been observed in adult patients treated with atypical antipsychotics2

*Observed cases.
Year 1 includes 6 months of treatment in the open-label extension study and 6 months of treatment in the open-label continuation study.
Year 2 includes 6 months of treatment in the open-label extension study and 18 months of treatment in the open-label continuation study.


Glycemic control changes through 2 years

LATUDA had a minimal effect on patients’ glucose and HbA1c levels

Glycemic control changes from double-blind baseline in an adult open-label continuation study3*

 

Mean glycemic control measures at baseline of the 6-week, double-blind study (N=122) were: glucose 91.1 mg/dL, HbA1c: 5.33%1

  • The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient2
  • Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness2

*Observed cases.
Year 1 includes 6 months of treatment in the open-label extension study and 6 months of treatment in the open-label continuation study.
Year 2 includes 6 months of treatment in the open-label extension study and 18 months of treatment in the open-label continuation study.


Prolactin changes through 2 years

LATUDA had a minimal effect on patients’ prolactin levels

Prolactin change from double-blind baseline in an adult open-label continuation study1*

Latuda® (lurasidone HCl) Long-Term Study: Prolactin Changes seen in Adult Patients with Bipolar Depression Chart

Latuda® (lurasidone HCl) Long-Term Study: Prolactin Changes seen in Adult Patients with Bipolar Depression Chart

 

Median prolactin level at baseline of the 6-week, double-blind study (N=122) was 7.8 ng/mL.

  • The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient2
  • As with other drugs that antagonize dopamine D2 receptors, LATUDA elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds2

*Observed cases.
Year 1 includes 6 months of treatment in the open-label extension study and 6 months of treatment in the open-label continuation study.
Year 2 includes 6 months of treatment in the open-label extension study and 18 months of treatment in the open-label continuation study.


footer-cta-patient-support

Support Your Patients

Savings, support, and tools are available for your patients. Get the support they need.

footer-cta-efficacy

Proven Efficacy

LATUDA provides proven efficacy in patients with bipolar depression.

footer-cta-insights

Gain Expert Insights

What do your peers have to say about patients and treatment? Find out.

 


References:

  1. Pikalov A, Tsai J, Mao Y, Silva R, Cucchiaro J, Loebel A. Long-term use of lurasidone in patients with bipolar disorder: safety and effectiveness over 2 years of treatment. Int J Bipolar Disord. 2017;5( 1 ):9. doi: 10. 1186/ s40345-017-0075-7.
  2. LATUDA prescribing information. Sunovion Pharmaceuticals Inc. March 2018.
  3. Data on file. Sunovion Pharmaceuticals Inc.

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR LATUDA

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

Suicidal Thoughts and Behaviors
Antidepressants increased the risk of suicidal thoughts and behavior 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.

 

CONTRAINDICATIONS: LATUDA is contraindicated in the following:

Cerebrovascular Adverse Reactions, Including Stroke: In clinical trials, elderly subjects with dementia randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported with administration of antipsychotic drugs. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of antipsychotic drugs, including LATUDA, intensive symptomatic treatment and monitoring.

Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal involuntary movements) and the potential for it to become irreversible are believed to increase as the duration of treatment and total cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses or may even arise after discontinuation of treatment. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes Atypical antipsychotic drugs have caused metabolic changes including:

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Patients with diabetes should be regularly monitored for worsening of glucose control; those with risk factors for diabetes should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, LATUDA elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia has been reported with antipsychotics. Agranulocytosis (including fatal cases) has been reported with other agents in the class. Monitor complete blood count in patients with a pre-existing low white blood cell count (WBC)/absolute neutrophil count (ANC) or history of drug-induced leukopenia/neutropenia. Discontinue LATUDA at the first sign of a decline in WBC in the absence of other causative factors.

Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope. Generally, the risk is greatest at the beginning of treatment and when increasing the dose. Monitor patients vulnerable to hypotension and those with cardiovascular and cerebrovascular disease.

Falls: Antipsychotics may cause somnolence, postural hypotension, or motor and sensory instability, which may lead to falls, causing fractures or other injuries. For patients with disease, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during therapy.

Seizures: LATUDA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.

Potential for Cognitive and Motor Impairment: Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with LATUDA does not affect them adversely.

Body Temperature Regulation: Use LATUDA with caution in patients who may experience conditions that increase body temperature (e.g., exercising strenuously, exposure to extreme heat, concomitant medication with anticholinergic activity, or being subject to dehydration).

Dysphagia: Antipsychotics, including LATUDA, have been associated with esophageal dysmotility and aspiration, and should be used with caution in patients at risk for aspiration pneumonia.

Most Commonly Observed Adverse Reactions: Commonly observed adverse reactions (≥5% incidence and at least twice the rate of placebo) for LATUDA:

To report SUSPECTED ADVERSE REACTIONS, contact Sunovion Pharmaceuticals Inc. at 877-737-7226 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Indications

LATUDA is indicated for:

Before prescribing LATUDA, please read the full Prescribing Information, including Boxed Warning.