INDICATIONS AND USAGE
LATUDA is an atypical antipsychotic indicated
for the treatment of patients with schizophrenia. Efficacy was established in five
6-week controlled studies of adult patients with schizophrenia. 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.
IMPORTANT SAFETY INFORMATION FOR LATUDA
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete boxed warning.
- 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.
CONTRAINDICATIONS
LATUDA is contraindicated in the following:
- Any patient with a known hypersensitivity to lurasidone HCl or any components in
the formulation. Angioedema has been observed with lurasidone.
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole).
- Concomitant use with strong CYP3A4 inducers (e.g., rifampin).
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. The management of NMS should
include: 1) immediate discontinuation of antipsychotic drugs and other drugs not
essential to concurrent therapy; 2) intensive symptomatic treatment and medical
monitoring; and 3) treatment of any concomitant serious medical problems for which
specific treatments are available.
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. In short-term,
placebo-controlled studies, the median change from baseline to endpoint in prolactin
levels for LATUDA-treated females was -0.2 ng/mL and was 0.5 ng/mL for males. The
proportion of female patients with prolactin elevations ≥5x ULN was 5.7% for LATUDA-treated
patients versus 2.0% for placebo-treated female patients. The proportion of male
patients with prolactin elevations >5x ULN was 1.6% versus 0.6% for placebo-treated
male patients.
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
and in patients with known cardiovascular disease or cerebrovascular disease.
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: In short-term, placebo-controlled
trials, somnolence was reported in 17.0% (256/1508) of patients treated with LATUDA
compared to 7.1% (50/708) of placebo patients, respectively. 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: (incidence ≥5% and at least twice
the rate of placebo) in patients treated with LATUDA were somnolence, akathisia,
nausea and parkinsonism.
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are registered trademarks of Dainippon Sumitomo Pharma Co., Ltd.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma
Co., Ltd.
©2013 Sunovion Pharmaceuticals Inc. All rights reserved.
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PROPERTY OF SUNOVION PHARMACEUTICALS INC. CONFIDENTIAL AND PROPRIETARY. NOT FOR DISSEMINATION. © 2013 Sunovion Pharmaceuticals Inc.