Latuda (Lurasidone)

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR LATUDA

WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to patients receiving placebo (sugar pill). LATUDA is not approved for treating these patients. Antidepressants have increased the risk of suicidal thoughts and actions in some children, teenagers, and young adults. Patients of all ages starting treatment should be watched closely for worsening of depression, suicidal thoughts or actions, unusual changes in behavior, agitation, and irritability. Patients, families, and caregivers should pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. LATUDA is not approved for patients under the age of 18 years.

Neuroleptic malignant syndrome (NMS): NMS is a rare and potentially fatal side effect reported with LATUDA and similar medicines. Call your doctor right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; sweating; or muscle pain and weakness. LATUDA should be stopped if you have NMS.

Tardive dyskinesia (TD): TD is a serious and sometimes permanent side effect reported with LATUDA and similar medicines. Tell your doctor about any movements you cannot control in your face, tongue, or other body parts, as they may be signs of TD. TD may not go away, even if you stop taking LATUDA. TD may also start after you stop taking LATUDA.

Metabolic Changes

High blood sugar: High blood sugar and diabetes have been reported with LATUDA and medicines like it. If you have diabetes or risk factors for diabetes, your blood sugar should be tested at the beginning of and throughout treatment with LATUDA. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have blood sugar problems or signs of diabetes, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry.

High cholesterol and triglycerides: Increases in triglycerides and in LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported with LATUDA.

Weight gain: Some patients may gain weight while taking LATUDA. Your doctor should check your weight regularly.

Additional Important Warnings

• Other risks may include feeling dizzy or lightheaded upon standing, decreases in white blood cells (which can be fatal), or trouble swallowing. Tell your doctor if you experience any of these.
• LATUDA and medicines like it may raise the levels of prolactin. Tell your healthcare provider if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence.
• Tell your healthcare provider if you have a seizure disorder, have had seizures in the past, or have conditions that increase your risk for seizures.
• Tell your healthcare provider if you experience prolonged, abnormal muscle spasms or contractions, which may be a sign of a condition called dystonia.
• LATUDA can affect your judgment, thinking, and motor skills. You should not drive or operate hazardous machinery until you know how LATUDA affects you.
• LATUDA may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm.
• Tell your healthcare provider about all prescription and over-the-counter medicines you are taking or plan to take, since there are some risks for drug interactions with LATUDA. Avoid drinking alcohol while taking LATUDA.
• Tell your healthcare provider if you are pregnant or if you are planning to get pregnant. Avoid breast feeding while taking LATUDA.

The most common side effects for LATUDA in clinical studies:

• in adults with Bipolar Depression include: an inner sense of restlessness or need to move (akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; and sleepiness
• in adults with Schizophrenia include: sleepiness; an inner sense of restlessness or need to move (akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; and nausea

This is not a complete summary of safety information. Please discuss the full Prescribing Information for prescription LATUDA with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATIONS

LATUDA is used to treat:

• Depressive episodes in bipolar I disorder (bipolar depression) in adults when used alone or with lithium or valproate
• Schizophrenia in adults