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

 

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Frequently Asked Questions

If you or your patients have questions about LATUDA, review the most frequently asked questions below and get the answers you need. If your question isn't listed, more resources are available at Sunovion AnswersSM Support for LATUDA. Patients can also call Sunovion AnswersSM support specialists by phone at 1-855-5LATUDA (1-855-552-8832) any time between 8AM to 12 midnight (EST).

LATUDA should be taken with food (at least 350 calories).1 Visit our dosing information page for complete information.

Patients should:

  • Avoid eating grapefruit or drinking grapefruit juice while taking LATUDA, as these can affect the amount of LATUDA in the blood.1
  • Not drive, operate machinery, or do other dangerous activities until they know how LATUDA affects them. LATUDA may make them drowsy.1
  • Avoid getting overheated or dehydrated.1
  • Not over-exercise.1
  • Stay inside, in a cool place during hot weather, if possible.1
  • Stay out of the sun. They should not wear too much or heavy clothing.1
  • Drink plenty of water.1
  • Not drink alcohol while taking LATUDA. It may make some side effects of LATUDA worse.1

There are no studies of LATUDA use in pregnant women.1 The limited available data are not sufficient to inform a drug-associated risk of birth defects or miscarriage.1

Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.1 Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy.1 These symptoms have varied in severity.1 Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization.1 Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately.

The FDA no longer classifies drugs by pregnancy category; therefore, this information is no longer included in the LATUDA prescribing information. However, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LATUDA during pregnancy. For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.1

No, LATUDA tablets should not be cut in half.

Patients should store LATUDA tablets at room temperature between 68°F to 77°F (20°C to 25°C).1

LATUDA is indicated for: treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate in adults; treatment of schizophrenia in adult and adolescent patients age 13 to 17 years. Please see full Prescribing Information for complete information, including details on use in special populations.

You can request sample packs of LATUDA for your appropriate patients with bipolar depression by clicking here.

Eligible patients can save on their LATUDA prescription with the LATUDA Savings Card. You can order packs of 10 cards for your patients or order packs of 10 vouchers for a 14-day supply of LATUDA at no cost here.

The LATUDA Savings Program may help offset the cost of copay on your patients’ LATUDA prescription—as long as they meet the eligibility requirements.

Here’s how the program works:

If your patient has commercial insurance, the LATUDA Savings Card may reduce their copay to as little as $15* by saving them as much as $125 for a 30-day prescription for up to 12 monthly prescription fills in a calendar year.

If your patient pays cash for LATUDA, they will save up to $125 on the cost of up to 12 monthly prescriptions after paying the first $15.* If they have questions about affording therapy or if they have no insurance, or limited insurance, we will help connect them with the appropriate assistance programs.

To get the LATUDA Savings Card, your patients simply register online here or over the phone at 1-855-5LATUDA (1-855-552-8832). Then use the Card when they fill their LATUDA prescriptions.

*Restrictions apply.

The LATUDA Savings Card allows up to 12 uses with a valid prescription—each one for up to a 30-day supply.

Patients are not eligible if prescriptions are paid in part or full by any state or federally funded health care program, including but not limited to Medicare, Medicaid, VA, DOD, TRICARE, or where prohibited by law.


Reference:
1. Latuda® (lurasidone HCl) prescribing information. Sunovion Pharmaceuticals Inc. February 2017.

Important Safety Information & Indications

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.

Suicidality and Antidepressant Drugs
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior in patients over age 24. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. LATUDA is not approved for use in pediatric patients with depression.

 

CONTRAINDICATIONS
LATUDA is contraindicated in the following:

WARNINGS AND PRECAUTIONS
Cerebrovascular Adverse Reactions, Including Stroke: In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects. LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with administration of antipsychotic drugs, including LATUDA. NMS can cause hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.

Tardive Dyskinesia (TD): TD is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements that can develop in patients with antipsychotic drugs. There is no known treatment for established cases of TD, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Given these considerations, LATUDA should be prescribed in a manner that is most likely to minimize the occurrence of TD. If signs and symptoms appear in a patient on LATUDA, drug discontinuation should be considered.

Metabolic Changes

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 risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics 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 during treatment with atypical antipsychotics 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 during treatment with antipsychotic agents. Agranulocytosis (including fatal cases) has been reported with other agents in the class. Patients with a preexisting low white blood cell count (WBC) or a history of drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy, and LATUDA should be discontinued at the first sign of a decline in WBC in the absence of other causative factors.

Orthostatic Hypotension and Syncope: LATUDA may cause orthostatic hypotension. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension, in patients with known cardiovascular disease or history of cerebrovascular disease and in patients who are antipsychotic-naїve.

Seizures: LATUDA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold (e.g., Alzheimer’s dementia).

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: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing LATUDA for patients who will be experiencing conditions that may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.

Suicide: The possibility of suicide attempt is inherent in psychotic illness and close supervision of high-risk patients should accompany drug therapy. Prescriptions for LATUDA should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.

Dysphagia: 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. LATUDA and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.

ADVERSE REACTIONS
Commonly observed adverse reactions (≥5% incidence and at least twice the rate of placebo) for LATUDA:

Indications

LATUDA is indicated for:

 

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