Lurasidone

Lurasidone is a prescription medication used to treat schizophrenia and depression. Lurasidone belongs to a group of drugs called atypical antipsychotics. These medications work by acting on certain receptors in the brain that affect mood and behavior.

This medication comes in tablet form and is usually taken once daily, with food.

Common side effects include restlessness, nausea, and drowsiness. Do not drive or operate heavy machinery until you know how this medication affects you.

Lurasidone is a prescription medication used to treat:

• Schizophrenia in adults and adolescents (13 to 17 years)
• Depression associated with bipolar I disorder (bipolar depression) in adults (alone or with lithium or valproate)
• Depression associated with bipolar I disorder (bipolar depression) in pediatric patients (10 to 17 years) 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take lurasidone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The lurasidone dose your doctor recommends will be based on the following: 

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• Age

Schizophrenia Treatment:

• The recommended dose range for treating adolescents (13 to 17 years) 40 mg to 80 mg per day. 
• The recommended dose range for treating adults is 40 mg to 160 mg per day.

Bipolar Depression Treatment:

• The recommended dose range for pediatric patients (10 to 17 years) is 20 mg to 80 mg per day.
• The recommended dose range for adults is 20 mg to 120 mg per day. 

WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
• Lurasidone is not approved for use in patients with dementia-related psychosis.
• 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 with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.
• In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

Serious side effects have been reported with lurasidone including the following:

1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Medicines like lurasidone can increase the risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Lurasidone should not be used to treat people with dementia-related psychosis.
2. Increased risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions).
   • Talk to your, or your family member's, healthcare provider about:
     • all risks and benefits of treatment with antidepressant medicines.
     • all treatment choices for depression or other serious mental illness.
   • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
   • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or a history of suicidal thoughts or actions.
   • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
     • 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.
     • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
     • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
3. Neuroleptic malignant syndrome. This is a serious side effect of treatment with lurasidone. Tell your healthcare provider right away if you have any of the following symptoms: fever, unusually stiff muscles, dizziness, fainting or low blood pressure. 
4. Tardive dyskinesia. This condition results in repetitive and involuntary movements (movements that you cannot control. Tell your healthcare provider right away if you have some or all of the following symptoms of tardive dyskinesia: unusual eye blinking, lip smacking, tongue movements, or rapid jerking movements or slow repetitive movements in the arms or legs.
5. Metabolic changes. Lurasidone may cause people to gain weight or it may alter their blood sugar and cholesterol levels. While taking lurasidone, your doctor will monitor your weight, blood sugar and blood cholesterol levels. 
6. Hyperprolactinemia. Lurasidone may increase prolactin, which is a hormone our body naturally produces. Increased prolactin levels can change the levels of other hormones the body produces, which may result in decreased ability to have a baby, decreased bone density, lack of a menstrual cycle in women and lack of ability to have an erection in men. Your healthcare provider may monitor your levels of prolactin during treatment with lurasidone. 
7. Decrease in certain blood cell counts. Your healthcare provider will monitor your blood counts often during your first few months being treated with lurasidone. Tell your healthcare provider right away if you have a fever or other signs of infection (chills, tiredness, body aches), as this could be a sign that your blood cell count has dropped too low. 
8. Low blood pressure. Tell your healthcare provider right away if you experience signs of low blood pressure, such as dizziness, lightheadedness and unusually slow or fast heart rate. Your healthcare provider may monitor your heart rate and blood pressure during your treatment with lurasidone.  

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

Do not take Latuda if you:

• are allergic to lurasidone or any of its ingredients
• are taking certain other medicines called CYP3A4 inhibitors or inducers including ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, rifampin, avasimibe, St. John's wort, phenytoin, or carbamazepine. Ask your healthcare provider if you are not sure if you are taking any of these medicines.

Serious side effects have been reported with lurasidone. See "Drug Precautions" section.

Common side effects include:

• sleepiness or drowsiness
• restlessness and feeling like you need to move around (akathisia)
• difficulty moving, slow movements, muscle stiffness, or tremor
• nausea

These are not all the possible side effects of lurasidone. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, and herbal supplements. Especially tell your doctor if you take medicines for:

• depression
• high blood pressure - such as diltiazem (Cardizem, Cartia, Taztia, Tiazac, others), and verapamil (Calan, Covera, Isoptin, Verelan, in Tarka, and others)
• Parkinson's disease
• trouble sleeping
• abnormal heart beats or rhythm
• epilepsy - such as carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek)
• inflammation
• psychosis

This is not a complete list of lurasidone drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Lurasidone falls into category B. It is not known if lurasidone will harm your unborn baby. This medication should be used during pregnancy only if the potential benefit to the mother justifies the risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if lurasidone crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using lurasidone.

Medication must be taken with food (at least 350 calories).

Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition called tardive dyskinesia. Tardive dyskinesia may not go away, even if you stop taking lurasidone. Tardive dyskinesia may also start after you stop taking lurasidone.

Before you receive lurasidone, tell your healthcare provider if you have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start receiving lurasidone and during your treatment.

Undesirable changes in cholesterol and weight have been seen in patients treated with atypical antipsychotics such as lurasidone.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Do not drive or operate heavy machinery until you know how this medication affects you.