Indicated for:

Schizophrenia: (adult and adolescent patients 13 to 17 years):

• Treatment of adult and adolescent patients age 13 to 17 years with schizophrenia.

Adults: The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg per day to 160 mg per day. The maximum recommended dose is 160 mg per day.

Adolescents (13 –17 years): The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg per day to 80 mg per day. The maximum recommended dose is 80 mg per day.

Monotherapy Treatment for Major Depressive Episode Associated with Bipolar I Disorder (adult and pediatric patients 10 to 17 years):

• Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression).

Adults: The recommended starting dose of LATUDA is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 20 mg per day to 120 mg per day as monotherapy or as adjunctive therapy with lithium or valproate.The maximum recommended dose, as monotherapy or as adjunctive therapy with lithium or valproate, is 120 mg per day.

Pediatrics: The recommended starting dose of LATUDA is 20 mg given once daily as monotherapy. Initial dose titration is not required. The dose may be increased after one week based on clinical response. LATUDA has been shown to be effective in a dose range of 20 mg per day to 80 mg per day as monotherapy. The maximum recommended dose is 80 mg per day. 

Adjunctive Treatment for Major Depressive Episode Associated with Bipolar I Disorder: (adult patients):

• Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).

The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established.

The effectiveness of LATUDA in pediatric patients for the treatment of irritability associated with autistic disorder has not been established.

LATUDA should be taken with food (at least 350 calories).

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.

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.

Patients with Parkinson’s Disease or Dementia with Lewy Bodies are reported to have an increased sensitivity to antipsychotic medication.

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients from clinical worsening, and for emergence of suicidal thoughts and behaviors. LATUDA is not approved for use in pediatric patients with depression.

Antidepressant treatment can increase the risk of developing a manic or hypomanic episode, particularly in patients with bipolar disorder.

LATUDA is contraindicated with:

• Concomitant use with a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.)
• Concomitant use with a with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine, etc.)

LATUDA may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including LATUDA.

Tardive dyskinesia is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements that can develop in patients treated with antipsychotic drugs.

As with other antipsychotic drugs, LATUDA should be used cautiously in patients with a history of seizures or with conditions that lower the seizure threshold, e.g., Alzheimer’s dementia.

Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents.

Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain.

As with other drugs that antagonize dopamine D2 receptors, LATUDA elevates prolactin levels. Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds. Long-standing hyperprolactinemia, when associated with hypogonadism, may lead to decreased bone density in both female and male patients.

Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescription of these drugs is considered in a patient with previously detected breast cancer.

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics.

Leukopenia/neutropenia has been reported during treatment with antipsychotic agents. Agranulocytosis (including fatal cases) has been reported with other agents in the class.

LATUDA, like other antipsychotics, has the potential to impair judgment, thinking or motor skills.

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer’s dementia.

Grapefruit and grapefruit juice should be avoided in patients taking LATUDA, since these may inhibit CYP3A4 and alter LATUDA concentrations.

Concomitant use of LATUDA with moderate CYP3A4 inhibitors (e.g., diltiazem, atazanavir, erythromycin, fluconazole, verapamil) increase the exposure of lurasidone compared to the use of LATUDA alone. LATUDA dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4.

Concomitant use of LATUDA with moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin), increase the exposure of lurasidone compared to the use of LATUDA alone. LATUDA dose should be increased when used concomitantly with moderate inducers of CYP3A4.

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

Nursing Mothers: Discontinue drug or nursing, considering risk of drug discontinuation to the mother.

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• Use in patients under the age of 10 for monotherapy treatment of major depressive episode associated with bipolar I disorder (bipolar depression). GoToSource

• Use in patients under the age of 13 for schizophrenia. GoToSource

• Use in patients under the age of 18 for adjunctive treatment of major depressive episode associated with bipolar I disorder (bipolar depression). GoToSource

• Mania associated with bipolar disorder. GoToSource

• Dementia-related psychosis in geriatric patients. GoToSource

• Irritability associated with autistic disorder. GoToSource

• Anxiety, delirium, insomnia, agitation and aggression. GoToSource

• Post-traumatic stress disorder. GoToSource

Heart failure, sudden death and pneumonia in older patients with dementia. GoToSource

Tachycardia (rapid heart rate), blurred vision, neuroleptic malignant syndrome (life-threatening neurological disorder), tardive dyskinesia (involuntary movement disorder), hyperprolactinemia (excessive secretion of prolactin a hormone secreted by the pituitary gland), orthostatic hypotension (fall in blood pressure when upright position is assumed), leukopenia (decreased white blood cells), seizures, weight gain and hyperglycemia (high blood sugar). GoToSource

Worsening of schizophrenia, akathisia (restlessness), psychotic disorders, dystonia (involuntary muscle contractions), salivary hypersecretion, insomnia, prolongation of the QTc interval and sedation. GoToSource

Agranulocytosis (drug-induced blood disorder), suicidal ideation, anemia (low number of red blood cells), first-degree atrioventricular block, angina pectoris, bradycardia (slow heart rate), gastritis (inflammation of lining of stomach), rhabdomyolysis (destruction of skeletal muscle), kidney failure, erectile dysfunction, angioedema (swelling in deep layers of skin) and hypertension (high blood pressure). GoToSource

Lawsuits filed for hyponatremia.