About Latuda® (lurasidone HCl) - Information For HCPs

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How does LATUDA work? Watch a video about the potential mechanism of action of LATUDA.

Bipolar depression is different than other types of depression. LATUDA provides proven antidepressant efficacy in patients with bipolar depression.

  • Efficacy established in adults and in pediatric patients (10 to 17 years) with bipolar depression1
    • In adult studies, LATUDA monotherapy and adjunctive therapy with lithium or valproate were superior to placebo in the reduction of Montgomery-Åsberg Depression Rating Scale (MADRS) scores at Week 61
    • In the pediatric patients (10 to 17 years) study, LATUDA monotherapy was superior to placebo in the reduction of Children's Depression Rating Scale, Revised (CDRS-R) scores at Week 61
  • Safety and tolerability evaluated in multiple bipolar depression studies, including short-term pivotal studies and longer-term, open-label extension studies1
  • Once-daily dosing, taken with food (at least 350 calories)1

Proven Antidepressant Efficacy of Latuda® (lurasidone HCI)

What is LATUDA?

LATUDA is an atypical antipsychotic indicated for monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) and adjunctive treatment with lithium or valproate in adult patients with bipolar depression. Efficacy was established in patients with bipolar depression in two 6-week controlled studies in adults and in one 6-week controlled study in pediatric patients (10 to 17 years). 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. The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established. 

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What percentage of patients with bipolar disorder experience depressive symptoms at the onset of their illness?

It has been reported that __% of adult patients with bipolar disorder who were misdiagnosed were initially diagnosed with unipolar depression.

In the pivotal study of Latuda ® (lurasidone HCI) monotherapy in adult patients with bipolar depression, the primary rating scale used to assess depressive symptoms was the:

When considering the full diagnostic criteria for a major depressive episode, based on the DSM-5, which 2 factors may present differently in children and adolescents with bipolar disorder compared with adults?

What is the maximum recommended daily dose of Latuda ® (lurasidone HCI) for pediatric patients (10 to 17 years) with bipolar depression?

In the open-label extension phase of a pivotal study of Latuda ® (lurasidone HCI) monotherapy in adult patients with bipolar depression, mean weight change from baseline to Week 24 was:

As an adjunct therapy to lithium or valproate, the initial starting dose of Latuda ® (lurasidone HCI) for bipolar depression in adult patients is 20mg/day and can be titrated up to a maximum dose of ____ as needed.

The mean change from baseline in total cholesterol seen in adult patients treated with Latuda ® (lurasidone HCI) and lithium or valproate in the short-term adjunctive therapy study (up to Week 6) was:


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Proposed Mechanism of Action

Receptor-binding affinity: in vitro receptor-binding results


LATUDA Proposed Mechanism of Action Video

See how LATUDA is thought to work in relation to the brain neurotransmitters dopamine and serotonin. Although the mechanism of action (MOA) of LATUDA is unclear, this video presents a potential MOA for the treatment of bipolar depression.

Human Brain - Video
  • Although the mechanism of action of LATUDA is unclear, the efficacy of LATUDA in bipolar depression could be mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism1
  • The correlation between receptor-binding affinities and clinical outcomes is uncertain1

 Latuda® (lurasidone HCl) prescribing information. Sunovion Pharmaceuticals Inc. March 2018.
2. Ketter TA, Sarma K, Silva R, Kroger H, Cucchiaro J, Loebel A. Lurasidone in the long-term treatment of patients with bipolar disorder: a 24-week open-label extension study. Depress Anxiety. 2016;33(5):424-434.



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).


LATUDA is indicated for:

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