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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 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 behaviors in patients aged 24 years and younger. Monitor for clinical worsening and emergence of suicidal thoughts and behavior. LATUDA is not approved for use in pediatric patients with depression.

 

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. There is no known treatment for established TD, although 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, 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 Warnings.