Lurasidone (loo-RAS-i-done)

Treats schizophrenia and depression caused by bipolar disorder.

Brand Name(s):

Latuda

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Keep using this medicine for the full treatment time, even if you feel better after the first few doses.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using certain other medicines including carbamazepine, clarithromycin, ketoconazole, phenytoin, rifampin, ritonavir, St John's wort, or voriconazole.
• Some medicines can affect how lurasidone works. Tell your doctor if you are using any of the following:
  • Atazanavir, bosentan, diltiazem, efavirenz, erythromycin, etravirine, fluconazole, modafinil, nafcillin, or verapamil
  • Blood pressure medicine
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, blood or bone marrow problems, diabetes, prolactin-dependent breast cancer, Parkinson's disease, trouble swallowing, or a history of seizures or neuroleptic malignant syndrome (NMS). Tell your doctor if you have any kind of blood vessel or heart problems, including low blood pressure, heart failure, a low amount of blood, heart rhythm problems, or a history of a heart attack or stroke.
• This medicine may cause the following problems:
  • Increased risk of stroke
  • Neuroleptic malignant syndrome (NMS)
  • Tardive dyskinesia (a movement disorder)
  • Changes in blood sugar levels
• This medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel depressed and have thoughts about hurting yourself.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make you dizzy or drowsy, or to have trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, fast, slow, pounding, or uneven heartbeat
• Confusion, double vision, headache, trouble speaking, thinking, or walking
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Increased thirst, hunger, or urination
• Lightheadedness, dizziness, or fainting
• Mood or behavioral changes, or thoughts of hurting yourself or others
• Neck muscle spasm, throat tightness, trouble swallowing or breathing, or sticking out of the tongue
• Seizures
• Sweating, muscle stiffness
• Twitching or muscle movements you cannot control (often in your face, tongue, or jaw)

If you notice these less serious side effects, talk with your doctor:

• Anxiety or restlessness
• Diarrhea, nausea, vomiting, or upset stomach
• Sleepiness or unusual drowsiness, tiredness
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

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